FDA Alert News August 2007 - Food and drug administration press release for august 2007

Food and Drug Administration Press Releases

• Thu, 02 Aug 2007 22:45:00 GMT

Data from the U.S. Military Health System will soon help the U.S. Food and Drug Administration make decisions affecting the safety and use of FDA-regulatedproducts for all Americans.

The FDA, part of the U.S. Department of Health and Human Services, and the Department of Defense today announced a partnership to share data and expertise related to the review and use of FDA-regulated drugs, biologics, and medical devices.

General patient data such as prescriptions, lab results and patient weight will be used by the FDA to spot trends, which may identify potential concerns as well as recognize benefits of products.

The two agencies will protect all personal health information exchanged under the agreement, in accordance with federal law.

"FDA is privileged to collaborate with DoD to protect the health of all Americans," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "The opportunity to create systems to monitor the safety of products should directly benefit those cared for by the armed services as well as many others."

The partnership, which will operate under a memorandum of understanding (MOU), is part of the FDA's Sentinel Network, a medical product safety initiative first announced in January 2007. This initiative is intended to explore linking private sector and public sector information to create a virtual, integrated, electronic network. The MOU was signed by von Eschenbach and Assistant Secretary of Defense for Health Affairs S. Ward Casscells, M.D. Among the DoD programs involved in the agreement is TRICARE, the agency that administers the health care plan serving 9.1 million members of the uniformed services, retirees and their families. The first data shared will most likely be TRICARE prescription information.

"Currently, most drug studies performed prior to FDA approval involve about 1,000 patients, and follow up studies use similar numbers," said Casscells. "Data from the Military Health System will expand the possibilities to include millions of patients when it comes to follow up research. We have more than 6.6 million beneficiaries using the TRICARE pharmacy benefit alone."

The DoD and FDA will meet later this year to establish specific procedures and safeguards necessary to implement the MOU. Long range plans for the Sentinel Network call for a seamless national electronic information network that will include everything from new medical product information and patient care records to adverse event reports, and domestic and foreign clinical trials.

For more information:
FDA-DoD Memorandum of Understanding
http://www.fda.gov/oc/mous/domestic/FDA-DOD-INFO.html

• Refererence:
• Food and Drug Administration Press Releases

FDA Announces Program to Enhance States Food Safety Programs

• Tue, 31 Jul 2007 16:49:00 GMT

The U.S. Food and Drug Administration today launched a national program to bring about the adoption of more uniform, equivalent, and high quality regulatory programs by state agencies responsible for regulating facilities that manufacture, process, pack, or hold food under FDA’s jurisdiction.

“This risk-based program represents a significant step in further integrating our food safety system,” said Margaret O’K. Glavin, FDA’s associate commissioner for regulatory affairs. “We realize it will be several years before it’s fully implemented, but we’re confident this program will bring great benefits to the public health.”

Currently, programmatic activities can vary from state to state and such variations can lead to inconsistencies in oversight of food safety. Adoption of voluntary standards for state regulatory programs will establish a uniform basis for measuring and improving the performance of state programs for regulating manufactured food and help the state and federal authorities reduce foodborne illness hazards in food facilities.

The Manufactured Food Regulatory Program Standards are the result of five years of intensive cooperative effort by federal and state regulators. The standards define best practices for the critical elements of state regulatory programs designed to protect the public from foodborne illness and injury, including:

• the program’s regulatory foundation;
• staff training;
• inspection;
• quality assurance;
• food defense preparedness and response;
• foodborne illness and incident investigation;
• enforcement;
• education and outreach;
• resource management;
• laboratory resources; and
• program assessment.

Each standard has corresponding self-assessment worksheets. Several standards have supplemental worksheets and forms to assist state regulators in determining whether their state program addresses all of the elements in the standards.

The Manufactured Food Regulatory Program Standards have been approved by the U.S. Office of Management and Budget and will be pilot-tested in New York, Oregon, and Missouri before September 30, 2007.

FDA regulates about 80 percent of the food supply, which includes food for humans and animals, except meat products, poultry products, and egg products, which are regulated by the U.S. Department of Agriculture.

• Refererence:
• FDA Announces Program to Enhance States Food Safety Programs

FDA Permits Restricted Use of Zelnorm for Qualifying Patients

• Fri, 27 Jul 2007 13:25:00 GMT

The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55who meet specific guidelines.

In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available.

In addition to the age and gender restrictions, the IND protocol for Zelnorm limits use of the drug to those with IBS-C or CIC whose physicians decide the drug is medically necessary. Patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of Zelnorm.

On March 30, 2007, the FDA asked Novartis, the manufacturer of Zelnorm, to suspend its U.S. marketing and sales because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm compared with treatment with an inactive substance (placebo).

At that time, the FDA indicated that there might be patients for whom the benefits of Zelnorm treatment outweigh the risks and for whom no other treatment options were available. FDA committed to work with Novartis to allow access to Zelnorm for those patients through a special program. That work yielded this IND protocol.

"These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research (CDER). "Zelnorm will remain off the market for general use."

Irritable bowel syndrome is a disorder characterized most commonly by cramping, abdominal pain, bloating, constipation, and diarrhea. IBS causes a great deal of discomfort and distress, but it does not permanently harm the intestines and does not lead to disease. For some people, however, IBS can be disabling. They may be unable to work, attend social events, or even travel short distances.

Patients are considered to have chronic constipation if they have fewer than three complete spontaneous bowel movements per week and at least one of the following symptoms for at least 25 percent of those bowel movements: straining, hard stools, incomplete evacuation.

Physicians with IBS-C or CIC patients who meet the IND criteria should contact Novartis at 888- 669-6682 or 866-248-1348. Those who do not qualify for the Zelnorm treatment protocol may contact FDA’s Division for Drug Information about other options at 888-463-6332.

For more information:

Novartis Zelnorm Web page
www.zelnorm.com

National Institute of Diabetes and Digestive and Kidney Diseases—Irritable Bowel Syndrome
http://digestive.niddk.nih.gov/ddiseases/pubs/ibs/

International Foundation for Functional Gastrointestinal Disorders
www.iffgd.org

FDA Center for Drug Evaluation and Research
www.fda.gov/cder

• Refererence:
• FDA Permits Restricted Use of Zelnorm for Qualifying Patients

FDA Statement on Gene Therapy Clinical Trial

• Thu, 26 Jul 2007 22:48:00 GMT

On July 24, 2007 the U.S. Food and Drug Administration (FDA) was informed by Targeted Genetics Corporation of Seattle about the death of a patient who received an investigational gene therapy product in a clinical trial for thetreatment of active inflammatory arthritis.

FDA's condolences go to the patient's family.

FDA is providing this preliminary information in recognition of the public's interest in these types of new therapies.

Targeted Genetics notified FDA earlier that a patient in its trial experienced a serious adverse event. Even though the cause of the illness wasn't known, and is still uncertain, the agency immediately placed the trial on clinical hold--meaning no further product can be administered and no new patients can be enrolled.

The product that was being studied uses a particle called a vector that is designed to deliver treatment genes to target cells. The vector used is a recombinant adeno-associated virus (AAV) derived vector and delivers the gene for Tumor-Necrosis Factor -Receptor, with the intent to inhibit a key mediator of inflammation. In the study, the gene therapy was administered into the joint affected by the disease to reduce inflammation and disease in patients with active inflammatory arthritis.

More than 100 subjects have been enrolled in the trial, according to the company, without known similar serious events. However, the patient's illness was related in time to the receipt of a second injection of the product. Upon being alerted to the adverse event, FDA immediately began its investigation to determine whether the illness was related to the treatment. The investigation into the cause of the patient's illness and subsequent death is intensive and ongoing.

Targeted Genetics is cooperating with FDA's investigation and has agreed to provide the agency with ongoing results from various tests and all other information it is compiling that may help determine the cause of this patient's death. FDA is also coordinating with the National Institutes of Health in an effort to acquire a better understanding of the potential scientific and safety implications of this event. These matters will be discussed at the September meeting of the NIH Recombinant DNA Advisory Committee.

FDA is not aware of similar adverse events occurring in other gene therapy trials either with this specific product or with those that use other genes in AAV vectors. However, as a precaution, the agency is further reviewing all ongoing trials involving any use of AAV.

FDA recognizes the contributions of participants in clinical trials and places a high priority on potential safety issues – volunteers play a critical role in making treatments available that have the potential to help many other patients who need new treatments for serious diseases.
The agency is continuing to obtain and assess additional information to help determine, if possible, the cause of the event, and any potential implications and will take additional steps and provide updates as warranted.

• Refererence:
• FDA Statement on Gene Therapy Clinical Trial

FDA Nanotechnology Report Outlines Scientific, Regulatory Challenges

• Wed, 25 Jul 2007 18:00:00 GMT

The U.S. Food and Drug Administration (FDA)'s Nanotechnology Task Force today released a report that recommends the agency consider developing guidance and taking other steps to address the benefits and risks of drugs and medicaldevices using nanotechnology.

"Nanotechnology holds enormous potential for use in a vast array of products," said Commissioner of Food and Drugs Andrew von Eschenbach, M.D., who endorsed the Task Force Report and its recommendations on July 23, 2007. "Recognizing the emerging nature of this technology and its potential for rapid development, this report fosters the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials."

Scientists and researchers increasingly are working in the nanoscale, creating and using materials and devices at the level of molecules and atoms—1/100,000th the width of a human hair.

The FDA's Task Force Report on Nanotechnology addresses regulatory and scientific issues and recommends FDA consider development of nanotechnology-associated guidance for manufacturers and researchers. The Task Force was initiated by Commissioner von Eschenbach in 2006.

The Task Force reports that nanoscale materials potentially could be used in most product types regulated by FDA and that those materials present challenges similar to those posed by products using other emerging technologies. The challenges, however, may be complicated by the fact that properties relevant to product safety and effectiveness may change as size varies within the nanoscale.

The report also says that the emerging and uncertain nature of nanotechnology and the potentially rapid development of applications for FDA-regulated products highlight the need for ensuring transparent, consistent, and predictable regulatory pathways.

Anticipating the potential for rapid development in the field, the report recommends consideration of agency guidance that would clarify, for example, what information to give FDA about products, and also when the use of nanoscale materials may change the regulatory status of particular products. As with other FDA guidance, draft guidance documents would be made available for public comment prior to being finalized.

In addition, the report says the FDA should work to assess data needs to better regulate nanotechnology products, including biological effects and interactions of nanoscale materials. The agency also should develop in-house expertise and ensure consideration of relevant new information on nanotechnology as it becomes available, according to the report. FDA should evaluate the adequacy of current testing approaches to assess safety, effectiveness and quality of nanoscale materials.

FDA and 22 other federal agencies are part of the National Nanotechnology Initiative, a federal research and development program established to coordinate the multi-agency efforts in nanoscale science, engineering, and technology.

For more information:

FDA Nanotechnology Report

Report PDF: www.fda.gov/nanotechnology/taskforce/report2007.pdf

Report HTML: www.fda.gov/nanotechnology/taskforce/report2007.html

Consumer Article: www.fda.gov/consumer/updates/nanotech072507.html

National Nanotechnology Initiative: http://www.nano.gov/

Fact sheet: http://www.fda.gov/nanotechnology/taskforce/factsheet2007.html

• Refererence:
• FDA Nanotechnology Report Outlines Scientific, Regulatory Challenges

FDA Expands Its Nationwide Warning about the Risk of Botulism Poisoning From Certain Castleberry Food Products and Dog Food

• Sat, 21 Jul 2007 23:55:00 GMT

This press release translated:
En Español |Japanese | Korean |Chinese | Vietnamese | Russian | German

This press release was revised on July 23, 2007, to update the "best by" dates in the fourth paragraph.
This press release was revised on July 26, 2007 to update disposal instructions in the seventh paragraph.

The U.S. Food and Drug Administration is expanding its July 18 warning to consumers. This expansion is for consumers and pet owners regarding canned food products and dog food produced by Castleberry's Food Company of Augusta, Ga., due to the risk of botulinum toxin. Castleberry's is expanding the recall to include all of the following canned products with all "best by" and code dates, and FDA is warning consumers not to purchase or eatany of the canned products listed in the table below.

The agency is expanding its warning based in part on FDA test results and information obtained during a joint FDA and U.S. Department of Agricultureinspection of the Castleberry’s facility in Augusta, Ga.

Exposure to botulinum toxin can be fatal and two people in Texas and two people in Indiana remain seriously ill and hospitalized with botulism poisoning associated with eating Castleberry's Hot Dog Chili Sauce.

While the previous recall and the known illnesses are linked to "best by" dates of April 30 to May 22, 2009, the firm has extended the recall to include all products listed irrespective of "best by" date. The firm is cooperating with FDA in the recall of these products and has ceased processing and distribution.

In addition, Castleberry's is recalling other products containing meat, which are regulated by the U.S. Department of Agriculture. USDA is also warning the public not to eat certain brands of Castleberry's products containing meat. The list of these USDA-regulated products can be viewed at this link to the USDA website: http://www.fsis.usda.gov/News_&_Events/Recall_033_2007_expanded/index.asp

Consumers who have any of these products or any foods made with these products should throw them away immediately. Double bag the cans in plastic bags that are tightly closed then place in a trash receptacle for non-recyclable trash outside of the home. Additional instructions for safe disposal can be found at www.cdc.gov/botulism/botulism_faq.htm.

Retailers that have any of these products are asked to assure that they are removed from use and do not accidentally get reintroduced for sale, serviceor donation. Do not puncture cans or open them in any way for disposal as this will create a potential health hazard. (More information for retailers and foodservice establishments.)

Symptoms of botulism poisoning in humans can begin from 6 hours to 2 weeks after eating food that contains the toxin. Symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, and muscle weakness that moves progressively down the body, affecting the shoulders first then descending to the upper arms, lower arms, thighs, calves, etc. Botulism poisoning can also cause paralysis of the breathing muscles which can result in death unless assistance with breathing (mechanical ventilation) is provided. Individuals who show these symptoms and who may have recently eaten one of the Castleberry’s products currently under recall should seek immediatemedical attention.

The disease has only been seen occasionally in dogs. Ferrets are highly susceptible to botulinum toxin. The incubation period can be 2 hours to 2 weeks; in most cases, the symptoms appear after 12 to 24 hours. Botulism is characterized by progressive motor paralysis. Typical clinical signs may include muscle paralysis, difficulty breathing, chewing and swallowing, visual disturbances and generalized weakness may also occur. Death usually results from paralysis of the respiratory or cardiac muscles. Pet owners who have used these products and whose pets have these symptoms should contact their veterinarian immediately. At this time we are not aware of pet illnesses associated with these products although we recommend that all these products should be discarded.

Castleberry's recommends consumers with any questions or concerns about this recall should go to Castleberry’s website (www.castleberrys.com) or call Castleberry’s consumer hotline at 1-800-203-4412 or 1-888-203-8446.

Consumers with questions can call FDA at 1-888-SAFEFOOD.

• Refererence:
• FDA Expands Its Nationwide Warning about the Risk of Botulism Poisoning From Certain Castleberry Food Products and Dog Food

FDA Warns Consumers about Risk of Botulism Poisoning fromHot Dog Chili Sauce Marketed Under a Variety of Brand Names

• Wed, 18 Jul 2007 01:35:00 GMT

The U.S. Food and Drug Administration (FDA) is warning consumers not to eat 10 ounce cans of Castleberry’s Hot Dog Chili Sauce (UPC 3030000101), Austex Hot Dog Chili Sauce (UPC 3030099533), and Kroger Hot Dog Chili Sauce (UPC 1111083942) with “best by” dates from April 30, 2009 through May 22, 2009 due to possible botulism contamination. Botulism can be fatal. The “best by dates” can be found on the can lids.

Consumers who have any of these products or any foods made with these products should throw them away immediately. If the “best by” date is missing or unreadable consumers should throw the product out.

Two children in Texas and an Indiana couple who ate these products became seriously ill and have been hospitalized.

Symptoms of botulism poisoning can begin from 6 hours to 2 weeks after eating food that contains the toxin. Symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, and muscle weakness that moves progressively down the body, affecting the shoulders first then descending to the upper arms, lower arms, thighs, calves, etc. Botulism poisoning can also cause paralysis of the breathing muscles which can result in death unless assistance with breathing (mechanical ventilation) is provided.

Individuals who show these symptoms and who may have recently eaten Castleberry’s Hot Dog Chili Sauce, Austex Hot Dog Chili Sauce, or Kroger Hot Dog Chili Sauce should seek immediate medical attention.

All of the above products are manufactured by the Castleberry Food Company in Augusta, Georgia.

Castleberry has informed FDA that it is voluntarily recalling all of the potentially contaminated products and is cooperating with FDA, the Centers for Disease Control and Prevention (CDC), and the states’ active investigations into the cause of this contamination and scope of the products’ distribution.

Castleberry is also voluntarily recalling a numbr of products that are not under FDA’s regulatory authority. For a list of these products, visit: www.castleberrys.com/news_productrecall.asp.

FDA will provide updates as more information becomes available. Consumers can call the FDA at 1-888-723-3366.

Castleberry recommends consumers with any questions or concerns about thisrecall should go to Castleberry’s website (www.castleberrys.com)or call Castleberry’s consumer hotline at 1-888-203-8446.

• Refererence:
• FDA Warns Consumers about Risk of Botulism Poisoning fromHot Dog Chili Sauce Marketed Under a Variety of Brand Names

FDA Approves First of a Kind Medical Device to Treat Cervical Degenerative Disc Disease

• Tue, 17 Jul 2007 17:25:00 GMT

The U.S. Food and Drug Administration (FDA) approved for marketing the Prestige Cervical Disc, made by Medtronic Sofamor Danek of Memphis—the first artificial cervical (neck) disc for the treatment of cervical degenerative disc disease,one of the most common causes of neck and arm pain.

"The approval of this artificial disc means that people with cervical degenerative disc disease now will have another surgical option for treating this condition," said Daniel Schultz, M.D., director, Center for Devices and Radiological Health, FDA. "This device will help relieve pain and restore function."

The cervical spine (neck region) consists of seven bones (called the vertebrae), which are separated from one another by intervertebral discs. These discs allow the neck to bend and rotate.

The current surgical treatment involves removing a diseased or bulging disc in a patient's neck and fusing two or more bony vertebrae. The Prestige Cervical Disc would instead replace the impaired natural disc.

The PRESTIGE Cervical Disc consists of two main pieces of stainless steel that articulate against one another with a ball and trough (groove) http://www.fda.gov/cdrh/pdf6/p060018.jpg. After a doctor removes the impaired natural disc, the artificial disc is attached to the adjacent vertebrae with bone screws.

FDA based approval on the company's laboratory and animal testing, and on its clinical study of 541 patients. The clinical study showed that the device improved neck and/or arm pain, and was as safe and effective as cervical fusion, a common treatment for degenerative disc disease. The approval decision also took into account the recommendations of the Orthopedic and Rehabilitation Devices Panel of FDA's Medical Devices Advisory Committee, which reviewed the product in September.

As a condition of approval, the company will conduct a post-approval study over the next seven years to evaluate the longer term safety and effectiveness of the device. FDA will continue to monitor the device as part of the agency's overall effort to ensure that products remain safe and effective once they reach the marketplace.

FDA approved the PRESTIGE Cervical Disc as a class III device under the pre-market approval process. FDA's regulation of medical devices is risk-based, with devices classified into low-risk (class I), moderate-risk (class II), or high-risk (class III) categories. The FDA regulatory program includes requirements for registration and listing of products, for high-quality production using good manufacturing practices and for post-market reporting of adverse events.

• Refererence:
• FDA Approves First of a Kind Medical Device to Treat Cervical Degenerative Disc Disease

FDA Approves First Molecular-Based Lab Test to Detect Metastatic Breast Cancer

• Mon, 16 Jul 2007 21:05:00 GMT

The U.S. Food and Drug Administration today approved the first molecular-based laboratory test for detecting whether breast cancer has spread (metastasized) to nearby lymph nodes. The GeneSearch BLN Assay detects molecules that areabundant in breast tissue but scarce in a normal lymph node.

The presence or absence of breast cancer cells in underarm lymph nodes is a powerful predictor of whether the cancer has spread and is used to help decide appropriate therapy for a woman with metastatic breast cancer.

Lymph nodes are part of the system that helps protect the body against infection. The first lymph node that filters fluid from the breast is called the "sentinel node," because that is where breast cancer cells are likely to spread first.

During a lumpectomy or mastectomy to remove a breast tumor, surgeons commonly remove the sentinel node for examination under a microscope. Sometimes the sentinel node is examined immediately and if tumor cells are found, additional lymph nodes are removed. A more extensive microscopic examination, requiring one to two days for results, is almost always performed. If tumor cells are only found with the later microscopic examination, the patient may require a second surgery to remove the remaining lymph nodes.

"The GeneSearch BLN Assay offers a new approach to sentinel node testing," said Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. "Results of this rapid test are available while patients are on the operating table, providing a way for some women to avoid a second operation."

In a clinical trial, the GeneSearch BLN Assay showed strong agreement with results from extensive microscopic examination of the lymph nodes of 416 patients. The test accurately predicted that breast cancer had spread nearly 88 percent of the time in women with metastasis. Patients without metastasis were identified accurately 94 percent of the time.

Most of the women were also studied to compare the BLN Assay with immediate microscopic examination during surgery. The test gave fewer false negative results, but slightly more false positive results. A false negative test result, when the cancer has actually spread, may delay the needed removal of additional lymph nodes. A false positive test, indicating metastasis when there is none, may result in a more extensive surgery and puts the women at risk of  unnecessary lymphedema (swelling due to fluid build-up following lymph node removal) and other side effects.

The GeneSearch BLN Assay is manufactured by Veridex, a Johnson & Johnson Company, of Warren, N.J.

• Refererence:
• FDA Approves First Molecular-Based Lab Test to Detect Metastatic Breast Cancer

Update on Tainted Veggie Booty Snack Food

• Fri, 13 Jul 2007 20:14:00 GMT

Corrections were made in the 2nd and 8th paragraphs of this press release on July 16, 2007

The Food and Drug Administration (FDA) today confirmed that a strain of Salmonella Wandsworth bacteria found in Veggie Booty snack food is responsible for the disease outbreak that occurred between March and June 2007.

Laboratory testing conducted by the Minnesota Agricultural Lab previously confirmed initial epidemiologic evidence that implicated Veggie Booty snack food as the source of the outbreak. The results of FDA’s own testing added further confirmation.

Veggie Booty is marketed by Robert’s American Gourmet, of Sea Cliff, N.Y.

FDA continues to advise consumers not to eat any Veggie Booty and to throw away product they have. FDA also advises consumers not to eat Super Veggie Tings Crunchy Corn Sticks, and to throw out any supplies they have, because this product also may be contaminated.

No illnesses have been associated with any other Robert's American Gourmet products.

Salmonella typically causes diarrhea (may be bloody), often accompanied by abdominal cramps and fever. Symptoms typically begin within one to four days after exposure to the bacteria. In infants and persons with poor underlying health and those with weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections.

Individuals who have recently eaten Veggie Booty or Super Veggie Tings Crunchy Corn Sticks and who have experienced any of the symptoms described above should contact a doctor or other health care provider immediately. Both products may appeal to children, so parents should be especially vigilant and seek medical care if they observe signs of illness.

The Centers for Disease Control and Prevention (CDC) has identified 60 persons, mostly toddlers, from 19 states who have become ill. Five persons were hospitalized. No deaths have been reported. States reporting illnesses include: California (seven cases), Colorado (five), Connecticut (two), Georgia (one), Illinois (one), Indiana (one), Massachusetts (four), Minnesota (two), New Hampshire (two), New Jersey (two), New York (15), Oregon (one), Pennsylvania (four), Tennessee (one), Texas (two), Virginia (one), Vermont (three), Washington (four), and Wisconsin (two).

FDA, the States, and CDC are continuing the investigation. Preliminary testing suggests that the seasoning mix used in Veggie Booty may be the source of the contamination. FDA will continue to trace back the ingredients and processing methods used for the seasoning mix, seeing to determine whether the seasoning actually is the source of the problem.

Veggie Booty is sold in a flexible plastic foil bag in four ounce, one ounce and one-half ounce packages. Some gift baskets available for purchase on the internet include Veggie Booty or Super Veggie Tings Crunchy Corn Sticks.

Robert’s American Gourmet ceased distributing Veggie Booty and began recalling the product on June 28. The company has also voluntarily recalled all lots and sizes of Super Veggie Tings Crunchy Corn Sticks snack food because the same potentially contaminated seasoning may have been used in making that product, too. In addition, the manufacturer of Veggie Booty and other products for Robert’s has ceased production until this investigation is complete. Robert's American Gourmet and its contract manufacturer are fully cooperating with FDA's investigation into the cause of the contamination.

FDA will provide additional updates as the investigation progresses and more information becomes available.

Wellbaskets.com Is Alerting Customers of the Veggie Booty Voluntary Recall Issued on June 28, 2007 by Robert's American Gourmet (July 2, 2007)

Robert’s American Gourmet Food, Inc. Conducts a Nationwide Recall of Super Veggie Tings Crunchy Corn Sticks Because of Possible Health Risk (July 2, 2007)

Photo: Robert's American Gourmet Super Veggie Tings Crunchy Corn Sticks

FDA's Pilot Program to Better Educate Consumers about Recalled Food Products

Robert's American Gourmet Food, Inc. Conducts Nationwide Recall of Veggie Booty Because of Possible Health Risk (June 28, 2007)

Veggie Booty Snack Food Identified in Product Recall (June 28, 2007)

FDA Press Release (June 28, 2007)

• Refererence:
• Update on Tainted Veggie Booty Snack Food

FDA Approves CustomVue Monovision LASIK

• Thu, 12 Jul 2007 12:35:00 GMT

The U.S. Food and Drug Administration approved for marketing the first LASIK device designed for treating one eye to see far away objects and the other eye for close-up vision.

“The approval of the CustomVue Monovision LASIK expands permanent vision correction options for nearsighted adults who also have trouble focusing on objects close-up,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “Unlike traditional LASIK, Monovision LASIK may reduce the need for reading glasses in some people over 40.”

LASIK, or laser in-situ keratomileusis, is a procedure in which the surgeon cuts a flap in the outer layers of the cornea, removes a small amount of the tissue beneath it with the laser, and then replaces the flap. CustomVue Monovision LASIK produces monovision correction in nearsighted (myopic) adults, with or without astigmatism, ages 40 years or older with normal age-related loss of ability to focus on near objects (presbyopia).

The CustomVue device is designed to correct all nearsightedness in the patient’s dominant eye and only part of the nearsightedness in the non-dominant eye. This allows the patient to use the fully corrected eye for distance vision and the under-corrected eye for seeing close up. After a period of time, the brain adjusts to the difference in perception between the two eyes.

People considering CustomVue monovision LASIK should first wear monovision contact lenses for at least a week to determine if they can tolerate having one eye under-corrected. Following monovision surgery, the two eyes may not work together as well as they did before in some patients, especially in dim light or when performing tasks requiring very sharp vision or fine depth perception. Patients may need to wear glasses or contact lenses for some activities such as night driving or reading small type.

CustomVue Monovision LASIK is a permanent operation to the cornea. Side effects may include glare from bright lights, rings around lights (halos), light sensitivity, night driving glare, ghost images, double vision and visual fluctuation.

CustomVue Monovision LASIK is manufactured by AMO/VISX Inc., based in Santa Clara, Calif. The new approval is for the monovision correction, which uses the previously approved wavefront-guided treatments—an eye-mapping system that guides the laser—for myopia and astigmatism. FDA based its approval on the review of a clinical study of safety and effectiveness outcomes submitted by the company.

At FDA’s request, AMO/VISX will conduct a post-approval study following 500 patients for six months after surgery to characterize quality of vision and quality of life issues associated with permanent LASIK monovision correction. The objective of the study is to estimate the proportion of monovision LASIK patients who experience visual disturbances that are severe enough to limit activities or adversely affect a patient’s quality of life.

• Refererence:
• FDA Approves CustomVue Monovision LASIK

FDA Finds Consumers Continue to Buy Potentially Risky Drugs Over the Internet

• Mon, 02 Jul 2007 18:35:00 GMT

The U.S. Food and Drug Administration continues to warn the American public about the dangers of buying medications over the Internet.

New data collected by the FDA show that consumers who are trying to save money on prescription drugs don’t need to take chances by buying prescription drugs from foreign Internet sites, because low-cost generic versions are available in the United States. This finding also may be an indication that some consumers are likely buying foreign drugs this way to avoid getting a prescription from their doctor or health care professional, since many Web sites do not require a prescription.

Safety Concerns
The use of prescription drugs without a prescription is an intrinsically unsafe practice. FDA urges consumers to have a prescription from their doctor or other health care professional before using prescription drugs. The agency also urges consumers to review www.fda.gov for important information before making such purchases.

Consumers should be aware of safety concerns of drugs purchased from unregulated Internet sellers since some of these drugs might:

• require careful dosing and monitoring;
• not have adequate labeling for safe use;
• be inappropriately packaged, therefore product integrity is uncertain;
• have been withdrawn from the U.S. market for safety or efficacy reasons;
• may carry risks that require initial screening and/or periodic patient monitoring;
• cause harm—such as a controlled substance (narcotic), whose use should be supervised by a doctor or health care professional due to abuse potential; and
• have clinically significant drug-drug interactions.

Recent examinations of a sample of drugs shipped to U.S. consumers found several drugs are associated with higher risks and are more dangerous to the consumer if used without the supervision of a doctor or health care professional. For example, warfarin (an anticoagulant or blood thinner) is a medication that requires very close monitoring to prevent stroke or death. Another example is amoxicillin and other antibiotics that should not be used for self treatment to reduce the risk of antibiotic-resistant infections. Levothyroxine, a thyroid replacement hormone, also requires close monitoring to ensure effective treatment. Another blood thinner, clopidogrel, may pose increased risk of cardiac events, such as heart attack if used in sub-optimal doses, which might be found in imported tablets. (See more examples in Table 2).

Consumers are also at risk if the drugs are not properly labeled for safe and effective use. For example, alendronate sodium, which is used to treat and prevent osteoporosis, should include information warning patients of significant side effects if it is not taken appropriately. Imported eye drop preparations may not have been manufactured under proper conditions to ensure sterility, leaving patients susceptible to contamination that may result in serious infections. These are only a few examples demonstrating the importance of obtaining FDA-approved drugs and health care provider monitoring.

Cost Concerns
The examination of foreign mail shipments also found that about 45 percent of the imported products already are available in the United States as an FDA-approved generic drug (see Table 1). About half of these generic drugs are available through national pharmacy chain programs that offer generic prescriptions at a cost of $4 each. This cost is usually significantly less than the cost of drugs charged by Internet sellers.

FDA has documented problems with imported drug products and has taken action when possible against foreign Web sites selling counterfeit products. Some examples follow.

• FDA Updates its Nationwide Alert on Counterfeit Blood Glucose Test Strips (October 23, 2006)
  www.fda.gov/bbs/topics/NEWS/2006/NEW01497.html
• FDA Warns Consumers Not to Buy or Use Prescription Drugs from Various Canadian Websites that Apparently Sell Counterfeit Products (August 30, 2006)
  www.fda.gov/bbs/topics/NEWS/2006/NEW01441.html
• Federal Authorities Cease Sale and Distribution of Counterfeit Lipitor (August 31, 2005)
  www.fda.gov/bbs/topics/news/2005/new01228.html
• FDA Takes Action Against Company for Illegal Importation of Unapproved, Potentially Unsafe Drugs (December 01, 2004)
  www.fda.gov/bbs/topics/news/2004/NEW01142.html
• FDA Warns Consumers About Counterfeit Drugs Purchased in Mexico (July 30, 2004)
  www.fda.gov/bbs/topics/ANSWERS/2004/ANS01303.html
• FDA Test Results of Prescription Drugs from Bogus Canadian Website Show All Products Are Fake and Substandard (July 13, 2004)
  www.fda.gov/bbs/topics/news/2004/NEW01087.html
• FDA Takes Action Against Foreign Websites Selling Counterfeit Contraceptive Patches (February 12, 2004)
  www.fda.gov/bbs/topics/NEWS/2004/NEW01023.html
• FDA and Johnson & Johnson Warn Public About Counterfeit Contraceptive Patches Sold Through Foreign Internet Site (February 04, 2004)
  www.fda.gov/bbs/topics/NEWS/2004/NEW01017.html
• FDA/U.S. Customs Import Blitz Exams Reveal Hundreds of Potentially Dangerous Imported Drug Shipments (September 29, 2003)
  www.fda.gov/bbs/topics/NEWS/2003/NEW00948.html
  

• Refererence:
• FDA Finds Consumers Continue to Buy Potentially Risky Drugs Over the Internet

FDA Approves First Generic Versions of Lamisil Tablets

• Mon, 02 Jul 2007 18:29:00 GMT

The U.S. Food and Drug Administration today approved the first generic versions of prescription Lamisil (terbinafine hydrochloride) tablets, used to treat nail fungus infection (onychomycosis). Such infections occur when fungi invade a fingernail or toenail or the skin underneath the nail.

"This approval offers Americans additional alternatives when choosing medications to treat nail fungus infections," said Gary J. Buehler, R.Ph., director of FDA's Office of Generic Drugs.

FDA approved applications from multiple generic drug manufacturers for terbinafine hydrochloride tablets in 250-milligram formulations. Manufacturers include: Amneal Pharmaceuticals, Apotex Corp., Aurobindo Pharma USA Inc., Dr. Reddy's Laboratories Ltd., Gedeon Richter USA Inc., Genpharm Inc., Glenmark Pharmaceuticals Inc., InvaGen Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Orgenus Pharma Inc., Roxane Laboratories Inc., TEVA Pharmaceuticals USA, Watson Laboratories Inc., Wockhardt USA Inc.

The remaining patent or exclusivity for Lamisil expired on June 30, 2007.

According to the online trade magazine, Drug Topics, Lamisil tablets are the 57th highest selling brand-name prescription drug by retail dollars in the United States.

In addition to terbinafine tablets, FDA also approved an application for a generic version of over-the-counter Lamisil cream (terbinafine hydrochloride,1 percent) to treat athlete's foot, a skin disease caused by a fungus that usually occurs between the toes. The cream is manufactured by Taro Pharmaceuticals U.S.A. Inc.

The FDA's Office of Generic Drugs ensures that generic drugs are safe and effective through a thorough scientific and regulatory process.

For more information:
Office of Generic Drugs
www.fda.gov/cder/consumerinfo/generic_equivalence.htm.

Generic Drugs: What You Need to Know
www.fda.gov/fdac/features/2002/502_generic.html.

FDA monthly reports for first-time generics
www.fda.gov/cder/ogd/approvals/

• Refererence:
• FDA Approves First Generic Versions of Lamisil Tablets

FDA Warns Consumers Not to Eat Veggie Booty Snack Food

• Thu, 28 Jun 2007 23:18:00 GMT

The U.S. Food and Drug Administration is warning consumers not to eat Veggie Booty flavor of snack food, marketed by Robert's American Gourmet, due to possible contamination with Salmonella Wandsworth, bacteria that cause gastrointestinalillness.

FDA advises consumers to throw away any Robert's American Gourmet brand Veggie Booty they have in their home. Veggie Booty is sold in a flexible plastic foil bag in four ounce, one ounce, and one-half ounce packages. No other flavors or varieties of snack food marketed by Robert's American Gourmet have been associated with Salmonella Wandsworth contamination.

Veggie Booty is often consumed by children, so parents are encouraged to watch their children, and seek medical care if they observe signs of illness.

Individuals who have recently eaten Veggie Booty and who have experienced any of the symptoms described below should contact a doctor or other health care provider immediately. Any such illnesses in persons with a recent history of eating Veggie Booty should be reported to state or local health authorities.

This warning is based on 52 reports of illness across 17 states, beginning in March 2007. Almost all the illnesses have occurred in children under 10 years old, with the most cases in toddlers. Most persons had reported bloody diarrhea; four were hospitalized. FDA learned of the illnesses on June 27 from the Centers for Disease Control and Prevention, which conducted an investigation of the illnesses with state and local health officials. The outbreak is considered likely to be ongoing.

Salmonella typically causes diarrhea (may be bloody); the diarrhea is often accompanied by abdominal cramps and fever. Symptoms typically begin within one to four days after exposure to the bacteria. In infants, persons with poor underlying health and those with weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections.

States reporting illnesses include: California (seven cases), Colorado (five cases), Connecticut (one case), Georgia (one case), Indiana (one case), Massachusetts (three cases), Minnesota (two cases), New Hampshire (two cases), New Jersey (two cases), New York (13 cases), Oregon (one case), Pennsylvania (three cases), Tennessee (one), Texas (one), Vermont (three cases), Washington (four cases), and Wisconsin (two cases).

Robert's American Gourmet, of Sea Cliff, N.Y., which markets Veggie Booty, and its contract manufacturer, are fully cooperating with FDA's investigation into the cause of the contamination. Manufacturing and distribution of this product has ceased, and Robert's American Gourmet is recalling all potentially contaminated product, including all expiration dates and lot codes. The product is sold in all 50 states and Canada at retail locations and over the Internet.

FDA’s comprehensive investigation has begun at the manufacturing facility, focused on identifying the source of the contamination. Product samples have been collected and will be analyzed in FDA laboratories. Typical microbiological analysis takes approximately seven days. The Centers for Disease Control and Prevention are also continuing their investigation in close collaboration with state health departments and FDA. FDA will provide additional updates as the investigation progresses and more information becomes available.

• Refererence:
• FDA Warns Consumers Not to Eat Veggie Booty Snack Food

FDA Detains Imports of Farm-Raised Chinese Seafood

• Thu, 28 Jun 2007 19:19:00 GMT

En Español  | 

The Food and Drug Administration (FDA) today announced a broader import control of all farm-raised catfish, basa, shrimp, dace (related to carp), and eel from China. FDA will start to detain these products at the border until the shipments are proven to be free of residues from drugs that are notapproved in the United States for use in farm-raised aquatic animals.

This action by FDA, a part of the U.S. Department of Health and Human Services, will protect American consumers from unsafe residues that have been detected in these products. There have been no reports of illnesses to date.

"We're taking this strong step because of current and continuing evidence that certain Chinese aquaculture products imported into the United States contain illegal substances that are not permitted in seafood sold in the United States," said Dr. David Acheson, FDA's assistant commissioner for food protection. "We will accept entries of these products from Chinese firms that demonstrate compliance with our requirements and safety standards."

During targeted sampling from October 2006 through May 2007, FDA repeatedly found that farm-raised seafood imported from China were contaminated with antimicrobial agents that are not approved for this use in the United States.

The contaminants were the antimicrobials nitrofuran, malachite green, gentian violet, and fluoroquinolone. Nitrofuran, malachite green, and gentian violet have been shown to be carcinogenic with long-term exposure in lab animals. The use of fluoroquinolones in food animals may increase antibiotic resistance to this critically important class of antibiotics.

None of these substances is approved for use in farm-raised seafood in the United States, and the use of nitrofurans and malachite green in aquaculture is also prohibited by Chinese authorities. Chinese officials have acknowledged that fluoroquinolones are used in Chinese aquaculture and are permitted for use in China.

The levels of the drug residues that have been found in seafood are very low, most often at or near the minimum level of detection. FDA is not seeking recall of products already in U.S. commerce and is not advising consumers to destroy or return imported farm-raised seafood they may already have in their homes. FDA is concerned about long term exposure as well as the possible development of antibiotic resistance.

The FDA action includes conditions under which an exporter can be exempted from FDA's detention action by providing specified information to the agency. This information must demonstrate the exporter has implemented steps to ensure its products do not contain these substances and that preventive controls are in place. The additional import controls placed on seafood from China will last as long as needed.

FDA may allow the entry into the United States and subsequent distribution into the marketplace of individual shipments of the Chinese farm-raised seafood products if the company provides documentation to confirm the products are free of residues of these drugs.

• Refererence:
• FDA Detains Imports of Farm-Raised Chinese Seafood

Food and Drug Administration Press Releases

• Fri, 03 Aug 2007 17:42:00 GMT

The U.S. Food and Drug Administration (FDA) is warning consumers not to eat certain brands of French Cut Green Beans in 14.5 ounce cans manufactured by Lakeside Foods Inc, of Manitowoc, Wisconsin because the product may not have been processed adequately to eliminate the potential for botulism toxin. Thiswarning is not related to another recent warning for botulism.

The canned green beans may cause botulism if consumed. FDA is providing this warning to make consumers aware of the possible risk of serious illness from eating these products. As of August 1, 2007, FDA had not received reports of illnesses related to the product.

The botulism toxin is very potent, and botulism is a life-threatening illness. Symptoms of botulism can begin from six hours to two weeks after eating food that contains the toxin. The symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, and muscle weakness that moves progressively down the body, affecting the shoulders first then descending to the upper arms, lower arms, thighs, and calves. Botulism also may cause paralysis of the breathing muscles, which can result in death unless assistance with breathing (mechanical ventilation) is provided. Individuals who show these symptoms and who may have recently eaten the product should seek immediate medical attention.

The affected Lakeside cut green beans are sold nationwide under the following labels: Albertson's, Happy Harvest, Best Choice, Food Club, Bogopa, Valu Time, Hill Country Fare, HEB, Laura Lynn, Kroger, No Name, North Pride, Shop N Save, Shoppers Valu, Schnucks, Cub Foods, Dierbergs, Flavorite, IGA, Best Choice and Thrifty Maid. The specific codes (top line of can code) involved are: EAA5247, EAA5257, EAA5267, EAA5277, EAB5247, EAB5257, ECA5207, ECA5217, ECA5227, ECA5297, ECB5207, ECB5217, ECB5227, ECB5307.

Consumers who have any of these products or any foods made with these products should dispose of them immediately. If the code on an affected can is missing or unreadable, consumers should throw the product out.

Lakeside Foods has informed FDA that it is voluntarily recalling all of the potentially contaminated products.

Lakeside Foods recommends that consumers with any questions or concerns about the recall should call the company at 800-466-3834 ext. 4090.

• Refererence:
• Food and Drug Administration Press Releases

Food and Drug Administration Press Releases

• Mon, 06 Aug 2007 22:13:00 GMT

The U.S. Food and Drug Administration (FDA) today approved maraviroc, an antiretroviral drug for use in adult HIV patients. Maraviroc, sold under the trade name Selzentry, is the first in a new class of drugs designed to slow the advancementof HIV and received priority review by the FDA.

Maraviroc is approved for use in combination with other antiretroviral drugs for the treatment of adults with CCR5-tropic HIV-1, who have been treated with other HIV medications and who have evidence of elevated levels of HIV in their blood (viral load). Rather than fighting HIV inside white blood cells, maraviroc prevents the virus from entering uninfected cells by blocking the predominant route of entry, the CCR5 co-receptor. CCR5 is a protein on the surface of some types of immune cells. Among patients who have previously received HIV medications, approximately 50 percent to 60 percent have circulating CCR5-tropic HIV-1. "This is an important new product for many HIV-infected patients who have not responded to other treatments and have few options," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research.

The product label includes a boxed warning about liver toxicity (hepatoxicity) and a statement in the Warnings/Precautions section about the possibility of heart attacks. The FDA's approval of maraviroc is based on safety and effectiveness data from two double-blind, placebo-controlled studies. The 1,076 clinical trial participants were selected because they still showed evidence of HIV-1 in their blood, despite treatment with other HIV medications. A blood test for CCR5 tropic HIV-1 was used during clinical trials to identify patients appropriate for treatment with maraviroc.

The safety and effectiveness of maraviroc have not been established in adult and pediatric patients who have never been treated with any other HIV drug. Additionally, the drug has not been tested or studied in pregnant women. The FDA recommends that HIV positive women should not breast feed, whether or not they are on antiretroviral medications.

The most common adverse events reported with maraviroc were cough, fever, upper respiratory tract infections, rash, musculoskeletal symptoms, abdominal pain, and dizziness.

Maraviroc is distributed by New York-based Pfizer Inc.

• Refererence:
• Food and Drug Administration Press Releases

Food and Drug Administration Press Releases

• Thu, 09 Aug 2007 22:35:00 GMT

A Complaint and Consent Decree of Permanent Injunction were filed Wednesday, August 8 in the U.S. District Court for the Northern District of Iowa, Western Division, against Ysselstein Dairy Inc., Rock Valley, Iowa, and its owner and president, Sjerp W. Ysselstein, after illegal drug residues were found in the dairy's cows. The permanent injunction will not become effective against Ysselstein Dairy until the Court signs and enters the Consent Decree. The action follows FDA investigations into the dairy and itspractices.

The FDA is concerned about the sale of animals for human food that may contain illegal levels of animal drugs because of the potential for adverse effects on human health. The FDA approves new animal drugs with requirements, including a specified time period to withdraw an animal from treatment prior to slaughter, to assure that a drug has been depleted from edible tissue to a level safe for humans.

Ysselstein Dairy produces milk for human consumption and sells dairy cows for slaughter for human consumption. The injunction is based on nine illegal residues in the edible tissue of seven dairy cows sampled by the U.S. Department of Agriculture's Food Safety Inspection Service (FSIS) between July 21, 1992, and March 10, 2006. The drug residues found by FSIS included antibiotics such as tetracycline, sulfadimethoxine, flunixin, oxytetracycline, and penicillin at levels not permitted by the FDA.

Under the terms of the Consent Decree, the dairy and Ysselstein must implement systems for identifying animals, keeping records, drug control, drug accountability, and drug residue withdrawal control. Furthermore, if the FDA informs the defendants of their not being in compliance with the terms of the Decree or the Federal Food, Drug, and Cosmetic Act, the FDA may require them to cease operations until they are in compliance. The Decree also provides for the dairy and Ysselstein to pay a fine for each day they fail to comply with the Decree and for each animal that they sell or deliver for sale in violation of the Decree.

FDA's Kansas City District Office conducted the investigations that led to the Consent Decree. FDA's Center for Veterinary Medicine Division of Compliance, FDA's Office of the Chief Counsel, and the U.S. Attorney's Office in the Northern District of Iowa processed and filed the case.

• Refererence:
• Food and Drug Administration Press Releases

FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol

• Thu, 09 Aug 2007 22:13:00 GMT

The U.S. Food and Drug Administration is warning consumers not to buy or eat three red yeast rice products promoted and sold on Web sites. The products may contain an unauthorized drug that could be harmful to health. The products are promoted as dietary supplements for treating high cholesterol.

The potentially harmful products are: Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics. FDA testing revealed the products contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for marketing in the United States as a treatment for high cholesterol.

“This risk is even more serious because consumers may not know the side effects associated with lovastatin and the fact that it can adversely interact with other medications," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research.

These red yeast rice products are a threat to health because the possibility exists that lovastatin can cause severe muscle problems leading to kidney impairment. This risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions. These medicines include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.

FDA has issued warning letters advising Swanson and Sunburst Biorganics to stop promoting and selling the products. Companies that do not resolve violations in FDA warning letters risk enforcement actions, such as an injunction against continuing violations and a seizure of illegal products.

The FDA warning letters state that the products Red Yeast Rice, Red Yeast Rice/Policosonal Complex, and Cholestrix, sold on the firm’s websites, are unapproved new drugs that are marketed in violation of the Federal Food, Drug, and Cosmetic Act. The warning letters are available on FDA’s Web site: www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm.

FDA advises consumers who use any red yeast rice product to consult their health care provider if they experience problems that may be due to the product.

Report adverse events related to these products to MedWatch, the FDA’s voluntary reporting program:
www.fda.gov/medwatch/report.htm; 800-332-1088; Fax: 800-332-0178; and MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

• Refererence:
• FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol

Food and Drug Administration Press Releases

• Fri, 10 Aug 2007 19:07:00 GMT

The U.S. Food and Drug Administration is warning consumers not to eat raw oysters harvested from an area of the southern tip of Hood Canal in Washington after an outbreak of illness caused by Vibrio parahaemolyticus bacteria. 

Symptoms of the illness, called vibriosis, include watery diarrhea, often with abdominal cramping, nausea, vomiting, fever, and chills. Usually these symptoms occur within 24 hours of ingestion and last no more than three days. Severe disease is rare and occurs most commonly in people with weakened immune systems. Those who believe they have experienced these symptoms after consuming raw oysters should consult their health care provider and contact their local health department.

Raw oysters harvested from “growing area 6” in Hood Canal from July 3, 2007 and after, have caused at least six people to become ill in California and Washington. Additional reports of illness are being investigated by the states. To date, records indicate that raw oysters from the area were distributed to California, Florida, Hawaii, Idaho, New York, Oregon, Washington, British Columbia (Canada), Hong Kong, Malaysia, and Singapore.

The Washington State Department of Health has closed the growing area associated with the illness and has asked commercial oyster harvesters and dealers who obtained oysters from this area to recall them. Consumers who have recently purchased oysters should check with the place of purchase and ask if they were harvested from the affected growing area. 

Those with weakened immune systems, including people affected by AIDS, chronic alcohol abuse, liver, stomach, or blood disorders, cancer, diabetes, or kidney disease should avoid eating raw oysters, regardless of where they are harvested.

FDA advises that consumers can continue to enjoy oysters in many cooked preparations by doing the following:

At Restaurants and other Foodservice Establishments:

• Order oysters fully cooked.

In the Shell:

• Purchase oysters with the shells closed.
• Throw away any oysters with shells already opened.
• Never allow raw seafood to come into contact with cooked food.
• Boil oysters until the shells open. Once shells open, boil for an additional three to five minutes.

To steam—add oysters to water that is already steaming and cook live oysters until the shells open, once open steam for another four to nine minutes.

• Use smaller pots to boil or steam oysters. Using larger pots, or cooking too many oysters at one time, may cause uneven heat distribution, which may cause the oysters in the middle to be under-cooked.
• Discard any oysters that do not open during cooking.

Shucked Oysters:

• Never allow raw seafood to come into contact with cooked food.
• Boil or simmer shucked oysters for at least three minutes or until the edges curl.
• Fry at 375 F for at least three minutes.
• Broil three inches from heat for three minutes.
• Bake at 450 F for 10 minutes.

For more information: Shellfish growing areas close due to vibriosis outbreak
www.doh.wa.gov/Publicat/2007_news/07-131.htm

• Refererence:
• Food and Drug Administration Press Releases

Food and Drug Administration Press Releases

• Thu, 16 Aug 2007 17:59:00 GMT

The U.S. Food and Drug Administration announced today the approval of updated labeling for the widely used blood-thinning drug, Coumadin, to explain thatpeople's genetic makeup may influence how they respond to the drug.

Manufacturers of warfarin, the generic version of Coumadin, are to add similar information to their products' labeling, FDA said.

The labeling change highlights the opportunity for healthcare providers to use genetic tests to improve their initial estimate of what is a reasonable warfarin dose for individual patients. Testing may help optimize the use of warfarin and lower the risk of bleeding complications from the drug.

These labeling updates are based on an analysis of recent studies that found people respond to the drug differently based, in part, on whether they have variations of certain genes.

FDA estimates that 2 million persons start taking warfarin in the United States every year to prevent blood clots, heart attacks and stroke. Warfarin is a difficult drug to use because the optimal dose varies and depends on many risk factors including a patient's diet, age, and the use of other medications.

Patients who take a dose larger than they can tolerate are at risk of life-threatening bleeding. Those who receive too low a dose are at risk of equally dangerous blood clots. Dosing is particularly important at the beginning of therapy, when problems in adjusting the dose can lead to complications such as bleeding.

Warfarin is the second most common drug – after insulin –implicated in emergency room visits for adverse drug events.

Physicians and other health care professionals who prescribe warfarin regularly check to see if the drug is working properly by ordering a test called the PT or prothrombin time that evaluates the blood's ability to clot properly. The results are measured in seconds and compared with the expected value in healthy people, known as the International Normalized Ratio or INR.

"Today's approved labeling change is one step in our commitment to personalized medicine. By using modern science to get the right drug in the right dose for the right patient, FDA will further enhance the safety and effectiveness of the medicines Americans depend on," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D.

The FDA's "personalized medicine" initiative makes use of pharmacogenomics—the science that predicts a response to drugs based upon a person's genetic makeup. This effort supports the personalized health program spearheaded by Health and Human Services Secretary Mike Leavitt.

A person's genes "encode" enzymes and differences in the sequence of a gene can cause differences in enzyme activity or sensitivity. That is why different people process the same drug differently.
 
One-third of patients receiving warfarin metabolize it quite differently than expected. Research has shown that some of the unexpected response to warfarin depends on a patient's variants of the genes CYP2C9 and VKORC1.

"Although genetic testing can currently identify who has these genetic variants, more studies are needed to explore the precise starting dose for these patients," said Larry Lesko, Ph.D., director of the FDA's Office of Clinical Pharmacology. "FDA has been working with other government agencies and organizations to develop such studies under the auspices of our three-year-old Critical Path Initiative, which addresses the challenges of moving promising medical products from discovery to patient use."

FDA's Critical Path Initiative has funded a research project with the University of Utah and the Critical Path Institute of Tucson, Ariz., to develop genetically based instructions for warfarin dosing. The Initiative has also facilitated meetings and planning with the National Heart, Lung and Blood Institute for a clinical trial that will study warfarin dosing based on genetic test information and is helping to pay for another clinical study being conducted by Harvard Partners that will derive personalized warfarin dosing algorithms for patients new to the drug.

The dosage and administration of warfarin must be individualized for each patient according to the particular patient's PT/INR response to the drug. The specific dose recommendations are described in the warfarin product labeling, along with the new information regarding the impact of genetic information upon the initial dose and the response to warfarin. Ongoing warfarin therapy should be guided by continued INR monitoring.

Bristol-Myers Squibb Co. of Princeton, N.J., is the manufacturer of Coumadin.

For more information see New Labeling Information for Warfarin.

• Refererence:
• Food and Drug Administration Press Releases

Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk

• Tue, 14 Aug 2007 21:46:00 GMT

The U.S. Food and Drug Administration today announced manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood. The information will be included in the form of a "boxed" warning—FDA's strongest form of a warning. The upgraded warning emphasizes that the drugsmay cause or worsen heart failure in certain patients.

After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepiride). These drugs are used in conjunction with diet and exercise, to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. FDA had asked the drug's manufacturers, GlaxoSmithKline and Takeda, to address these concerns.

"Under FDA's postmarketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and health care providers of new information," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "This new boxed warning addresses FDA's concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure."

FDA's review of adverse event reports found cases of significant weight gain and edema—warning signs of heart failure. In some reports, FDA noted, continuation of therapy has been associated with poor outcomes, including death.

The strengthened warning advises health care professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their health care providers to discuss alternative treatments.

The warning also states that these drugs should not be used by people with serious or severe heart failure who have marked limits on their activity and who are comfortable only at rest or who are confined to bed or a chair.

FDA's review of Avandia and possible increased risk of heart attacks is ongoing. On July 30, 2007, FDA's Endocrine and Metabolic Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended that Avandia continue to be marketed, and further recommended that information be added to the labeling for risk of heart attacks (ischemic risks).

For more information, visit:
Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information
Pioglitazone HCl (marketed as Actos and Duetact) Information

• Refererence:
• Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk

Federal Court Issues Permanent Injunction Against Puerto Rico Dairies for Drug Residues Found in Cows

• Tue, 14 Aug 2007 16:06:00 GMT

The United States District Court for the District of Puerto Rico issued an Order of Permanent Injunction against J.M. Dairy Inc. and Las Martas Inc., and Juan Manuel Barreto Ginorio, the owner of the dairies, after illegal drugresidues were found in cows.

The U.S. Food and Drug Administration is concerned about the sale of animals for human food that may contain illegal levels of animal drugs because of the potential for adverse effects on human health. FDA approves new animal drugs with requirements, including a specified time period to withdraw an animal from treatment prior to slaughter, to assure that a drug has been depleted from edible tissue to a level safe for humans. The order also prohibits the sale of milk until compliance is met.

The court order follows a civil complaint filed against the defendants on Sept. 19, 2006, based upon FDA's investigations into the dairies and their practices. The dairies produce milk for human consumption and sell dairy cows for slaughter for human consumption.

The injunction is based, in part, on five illegal residues in the edible tissue of three dairy cows sampled by the U.S. Department of Agriculture's Food Safety Inspection Service (FSIS) between August 2003 and September 2005. The drug residues found by FSIS included antibiotics such as sulfamethazine, sulfathiazole, sulfadimethoxine, and penicillin at levels not permitted by FDA. More recent FDA inspections confirmed that the dairies continued to use animal drugs in a manner contrary to the label directions, without the benefit of a veterinarian's oversight, and failed to maintain record-keeping systems to ensure that they did not sell milk or animals for slaughter for human food with illegal new drug residues.

Under the terms of the Aug. 8, 2007 order, the defendants must implement record-keeping systems to ensure that their use of drugs conforms to FDA regulations and that no milk or animals for slaughter for human food enters into interstate commerce with illegal new drug residues.

The defendants may only resume selling or delivering food—milk or animals for slaughter for human food—in interstate commerce after they are notified by FDA that they are in compliance with the terms of the order.

• Refererence:
• Federal Court Issues Permanent Injunction Against Puerto Rico Dairies for Drug Residues Found in Cows

Food and Drug Administration Press Releases

• Fri, 17 Aug 2007 14:22:00 GMT

The U.S. Food and Drug Administration (FDA) is concerned that nursing infants may be at increased risk of morphine overdose if their mothers are taking codeine and are ultra-rapid metabolizers of codeine. The agency has reviewed all available information on this subject since a medical journal reported the death of a 13-day old breastfed infant who died from morphine overdose. The morphine levels in the mother's milk were abnormally high after taking small doses of codeine to treat episiotomy pain. A genetic test showedthat the mother was an ultra-rapid metabolizer of codeine.

"Our best advice to physicians prescribing codeine-containing products to nursing mothers is to prescribe the lowest dose needed for the shortest amount of time," said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research. "And nursing mothers should always consult their physicians before taking any codeine containing products."

Codeine is an ingredient found in prescription and non-prescription medicines that are used to relieve pain or treat cough. Once in the body, some of the codeine is converted (metabolized) to morphine. Some people, due to their genetic makeup, metabolize codeine much faster and more completely than others. These people, called ultra-rapid metabolizers, are more likely to have higher-than-normal levels of morphine in their blood after taking codeine. Mothers who are ultra-rapid metabolizers may have higher-than-usual levels of morphine in breast milk.

According to the FDA, nursing mothers have used codeine safely for many years. In medical practice, codeine is generally considered the safest choice among narcotic pain relievers for nursing women and their babies. However, to raise awareness of this possible health risk and to prevent morphine overdose in nursing infants, FDA is requiring manufacturers of prescription codeine medicines to include information about codeine ultra-rapid metabolism in drug package insert information. In addition, FDA has posted information about this issue on the FDA website for healthcare providers and patients.

Nursing mothers taking codeine (or other narcotic pain relievers) should know how to watch for signs of overdose in their babies. Breast fed babies normally nurse every two to three hours and should not sleep for more than four hours at a time. Signs of morphine overdose in a nursing baby include increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness.

The chance of being an ultra-rapid metabolizer varies among different population groups from less than 1 per 100 people to 28 per 100 people. For people who are ultra-rapid metabolizers, the risk of having an adverse event when taking codeine is not known. The only way to know if someone is an ultra-rapid metabolizer is to do a genetic test. There is a FDA-cleared test to check for ultra-rapid metabolism, but there is only limited information about using this test for codeine metabolism. At this time, the test result alone may not correctly predict if a mother's breast milk will have too much morphine if she uses codeine to treat pain. This test cannot substitute for a doctor's judgment.

Mothers and babies gain many health benefits from breastfeeding. When a nursing mother must take medicine, her infant may be exposed to some risks from that medicine. It is important for healthcare professionals and nursing women using codeine or other medicines to discuss these risks and benefits.

For more information, go to Use of Codeine Products in Nursing Mothers.

• Refererence:
• Food and Drug Administration Press Releases

Food and Drug Administration Press Releases

• Wed, 22 Aug 2007 16:35:00 GMT

The U.S. Food and Drug Administration today approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17. This is the first FDA approval of an atypical antipsychotic drug to treat either disorder in these age groups.

Until now, there has been no FDA-approved drug for the treatment of schizophrenia for pediatric use and only lithium is approved for the treatment of bipolar disorder in adolescents ages 12 and up.

“The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose, and safety of using this product in the pediatric population,” said Dianne Murphy, M.D., director of FDA’s Office of Pediatric Therapeutics. “These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients.”

The FDA first approved Risperdal in 1993 for the treatment of schizophrenia in adults. The drug later was approved for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and the treatment of irritability associated with autistic disorder in children and adolescents 5 to 16 years old.

Evidence to support this approval was collected through studies the FDA requested as part of its pediatric drug development initiatives.

The efficacy of Risperdal in the treatment of schizophrenia in adolescents was demonstrated in two short-term (6 to 8 weeks), double-blind, controlled trials. All patients were experiencing an acute episode of schizophrenia at the time of enrollment. Treated patients generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of their illness.

The efficacy of Risperdal in the treatment of manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a three-week, randomized, double-blind, placebo-controlled, multicenter trial in patients who were experiencing a manic or mixed episode. Treated patients generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity, and other symptoms of their illness.

Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported.

Schizophrenia is a serious and disabling psychiatric disorder. Symptoms may include hallucinations, delusions, and disorganized thinking. Bipolar disorder, also known as manic-depressive illness, is a serious psychiatric disorder that causes wide shifts in a person's mood, energy, and ability to function.

Risperdal is manufactured by Janssen, L.P. of Titusville, N.J.

For more information:

FDA Office of Pediatric Therapeutics
www.fda.gov/oc/opt/default.htm

National Institute of Mental Health—Schizophrenia
www.nimh.nih.gov/healthinformation/schizophreniamenu.cfm

National Institute of Mental Health—Bipolar Disorder
www.nimh.nih.gov/healthinformation/bipolarmenu.cfm

• Refererence:
• Food and Drug Administration Press Releases

Food and Drug Administration Press Releases

• Thu, 23 Aug 2007 17:30:00 GMT

The U.S. Food and Drug Administration today proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC)sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.

"For more than 30 years, consumers have been able to identify the level of UVB protection provided by sunscreens using only sunburn protection factor or SPF values," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "Under today's proposal, consumers will also now know the level of UVA protection in sunscreens, which will help them make informed decisions about protecting themselves and their children against the harmful effects of the sun."

Sunlight is composed of the visible light that we can see, and ultraviolet (UV) light that we can not. There are two types of UV light, UVA and UVB. UVA light is responsible for tanning and UVB for sunburn. Both can damage the skin and increase the risk of skin cancer.

The proposed regulation creates a consumer-friendly rating system for UVA products designed to help consumers identify the level of UVA protection offered by a product. The FDA proposal provides a ratings system for UVA sunscreen products on a scale of one to four stars. One star would represent low UVA protection, two stars would represent medium protection, three stars would represent high protection, and four stars would represent the highest UVA protection available in an OTC sunscreen product. If a sunscreen product does not provide at least a low level (one star) of protection, FDA is proposing to require that the product bear a "no UVA protection" marking on the front label near the SPF value.

Ratings would be derived from two tests the FDA proposes to assess the effectiveness of sunscreens in providing protection against UVA light. The first test measures a product's ability to reduce the amount of UVA radiation that passes through it. The second test measures a product's ability to prevent tanning. This test is nearly identical to the SPF test used to determine the effectiveness of UVB sunscreen products.

In addition, a "Warnings" statement in the "Drug Facts" box will be required of all sunscreen product manufacturers. The warning will say: "UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen." The warning is intended to increase awareness that sunscreens are only one part of a sun protection program.

"Many consumers incorrectly believe that the only way to protect themselves from skin damage caused by the sun is to apply sunscreens," said Douglas Throckmorton, M.D., deputy director of FDA's Center for Drug Evaluation and Research. "The labeling being proposed today strengthens the existing labeling for sunscreens by educating consumers on the added importance of limiting their time in the sun and wearing protective clothing as part of a sun protection regimen."

When finalized, the proposed regulation would amend the existing OTC sunscreen rule published in 1999 that established regulations related to UVB light and mandated that OTC UVB sunscreen products be labeled with a SPF. FDA also is amending its existing 1999 rule to increase the SPF from SPF30+ to SPF50+. Previously, FDA had recognized SPF values up to 30+. Under the proposed amendment, the range would be SPF2 to SPF50+. SPF50 provides more UVB protection than lower SPF values. Additionally, the proposed rule:

• revises the existing SPF (UVB) testing procedures;
• allows new combinations of active ingredients; and
• asks for comments on the issue of nanoparticles.

FDA is accepting comments on the new rule for 90 days until November 26, 2007. Comments must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form. Electronic submissions can be submitted at the following Web sites:

Federal eRulemaking Portal: www.regulations.gov
FDA Web site: www.fda.gov/dockets/ecomments

Written submissions can be submitted by fax or mail:
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Fax: 301-827-6870

For more information:
FDA Web site for Sunscreen Proposed Rule

Consumer Article: FDA Aims to Upgrade Sunscreen Labeling

• Refererence:
• Food and Drug Administration Press Releases

Food and Drug Administration Press Releases

• Sat, 25 Aug 2007 18:00:00 GMT

The U.S. Food and Drug Administration is alerting consumers that Mars Petcare US, Inc. has recalled two dry dog food products because of the potential contaminationwith Salmonella Schwarzengrund.

The Mars Petcare US, based in Franklin, Tenn. is voluntarily recalling five-pound bags of Krasdale Gravy dry dog food sold in Connecticut, Massachusetts, New Jersey, New York, and Pennsylvania, and 50-pound bags of Red Flannel Large Breed Adult Formula dry food sold in Pennsylvania.

The FDA conducted tests on 10 samples, representing seven product brands from the company. Each sample (same size and brand of product) consisted of 15 subsamples, for a total of 150 subsamples. Tests of the 150 subsamples revealed two positive samples; one from the Krasdale Gravy dry food and another from Red Flannel Large Breed Adult Formula dry food.

Salmonella can potentially be transferred to people handling pet food, especially if they have not thoroughly washed their hands after having contact with the product or any surfaces exposed to the product. To date, there have been 64 cases of illness in humans related to Salmonella Schwarzengrund reported to the U.S. Centers for Disease Control and Prevention (CDC); however, none of the reported cases have been directly linked to the recalled product that was tested. The FDA is working with local and state officials, and with officials at the CDC in the investigation.

Here is identification information on the recalled products:

Product: Krasdale Gravy dry dog food
Size: Five-pound bag
UPC Code: 7513062596
Best By Date: July 16, 2008 & July 17, 2008
Best By Date Location: Back of bag
Distribution: Stores in Connecticut, Massachusetts, New Jersey, New York, and Pennsylvania

Product: Red Flannel Large Breed Adult Formula dry dog food
Size: 50-pound bag
UPC Code: 4286900062
Best By Date: July 12, 2008
Best By Date Location: Back of bag
Distribution: Stores in Reedsland and Richlandtown, Pa.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Well animals can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

Consumers with questions about the recalled product should call Mars Petcare US, Inc. at 866-298-8332.

For more information:
Safe Handling Tips for Pet Foods and Treats

Mars Petcare Pet Food Recall Questions andAnswers

Firm Release on Select Red FlannelLarge Breed Adult Formula Dry Dog Food (Aug. 21)

Firm Release on Select KrasdaleGravy Dry Dog Food (Aug. 21)

PennsylvaniaDepartment of Health Press Release (Aug. 10)

• Refererence:
• Food and Drug Administration Press Releases

Food and Drug Administration Press Releases

• Tue, 28 Aug 2007 22:32:00 GMT

The U.S. Food and Drug Administration today announced approval of a secondtest for the detection of West Nile virus (WNV) in blood and organs.

The cobas TaqScreen WNV test is an automated test that's able to detect the genetic material of the virus itself early in the infection. Such nucleic acid testing improves blood and organ safety, detecting whether donated blood and organs have been infected even before the donor's body has begun to produce antibodies against the virus.

Most often, WNV is transmitted to humans by mosquitoes. But WNV can also be transmitted by blood transfusion or organ transplantation from infected donors. While WNV infection is common in Africa, Asia, and the Middle East, it did not appear in the United States until 1999. Since then, WNV has become endemic in most of this country, with from 1 million to 3 million cases between 1999 and 2006, according to the Centers for Disease Control and Prevention.

"This action is the culmination of the dedicated efforts of FDA, our sister agencies, blood establishments, and manufacturers to bring donor screening tests to market for this increasingly common virus," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "As a result, blood centers and hospitals now have a choice of two FDA approved tests to screen for West Nile Virus in donated blood and organs."

Most people infected with WNV show no signs of the disease but about 1 in 150 to 1 in 350 infected people will develop serious symptoms, including encephalitis, an inflammation of the brain. Since the introduction of the virus, the reported number of human cases of serious WNV in the United States has grown steadily from 62 in 1999 to 4,269 in 2006.

WNV has been especially virulent this year. Although it is still early in the WNV season, 58 blood donors who are possibly positive for the virus have been reported to the CDC as of August 21, 2007.

The cobas TaqScreen WNV test is approved for the detection of the virus in plasma specimens from human donors of whole blood and blood components (plasma, red or white cells, platelets) and living donors of cells, reproductive cells and other tissues. It is also intended for use in testing plasma specimens of organ donors when specimens are obtained while the donor's heart is still beating. The test is not intended for use on samples of cord blood or as an aid in the diagnosis of WNV infection.

Approval comes as FDA is preparing guidance on the use of licensed WNV screening tests for blood donors.

The test is manufactured by Roche Molecular Systems Inc. of Pleasanton, Calif.

• Refererence:
• Food and Drug Administration Press Releases

FDA Approves Human Thrombin for Topical Use in Surgery

• Tue, 28 Aug 2007 14:27:00 GMT

The U.S. Food and Drug Administration approved Evithrom (human thrombin),a blood-clotting protein used to help control bleeding during surgery.

Evithrom is the first human thrombin approved since 1954 and is the only product currently licensed. It is derived from human plasma obtained from carefully screened and tested U.S. donors and has undergone steps to further reduce the risk for transfusion-transmitted diseases.

Evithrom is indicated as an aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical. The product is applied to the surface of bleeding tissue and may be used in conjunction with an absorbable gelatin sponge. Evithrom must not be injected into blood vessels, which would result in serious clinical complications and may even be fatal.

"The approval of Evithrom offers an important additional option for surgeons and their patients to help control surgical bleeding," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "Surgeons will now be able to choose between human thrombin and thrombin derived from cattle plasma."

In a clinical trial involving several hundred subjects, Evithrom was found comparable to cattle-derived thrombin in both safety and effectiveness.

Evithrom is manufactured by Omrix Biopharmaceuticals, Ltd., Ramat Gan, Israel, and will be distributed by Johnson & Johnson Wound Management, a division of Ethicon, Inc., Somerville, N.J.

• Refererence:
• FDA Approves Human Thrombin for Topical Use in Surgery