FDA Alert News July 2007 - Food and drug administration press release for july 2007

Food and Drug Administration Press Releases

• 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 As with other FDA guidance, draft guidance documents would be made available for public comment prior to being finalized.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:
• Food and Drug Administration Press Releases

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

FDA Clears for Marketing First Quick Test for Malaria

• Tue, 26 Jun 2007 20:57:00 GMT

The U.S. Food and Drug Administration has cleared for marketing the Binax NOW Malaria Test, the first authorized U.S. rapid test for malaria, a mosquito-bornedisease caused by a parasite. The test is intended for laboratory use.

Standard laboratory tests for malaria require identifying parasites in a blood sample under a microscope, a difficult task that requires training and experience.

The Binax NOW test is significantly faster and easier to use. Results are available in 15 minutes after a few drops of whole blood are placed on a dipstick. The test can also differentiate the most dangerous malaria parasite, Plasmodium falciparum, from less virulent malaria parasites. Results still need to be confirmed using standard microscopic evaluation.

People infected with malarial parasites often experience a high fever, chills, and flu-like illness. Left untreated, they may develop severe complications and die.

Although malaria has been eliminated from the United States since the 1950s, it can still affect U.S. residents who travel or who work in other countries. According to the Centers for Disease Control and Prevention, there were 1,528 newly-reported cases of malaria in the United States in 2005,  including seven deaths. Nearly all deaths can be prevented if the infection is diagnosed and treated early.

"Since malaria is uncommon in the United States, clinicians and lab personnel may not be accustomed to diagnosing this disease," said Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "When used in combination with other laboratory tests, the Binax NOW test provides an additional tool to help them diagnose this disease faster in the United States."

The Binax NOW test was 95 percent accurate compared with standard microscopic diagnosis in a multi-center study outside the United States in areas where malaria is prevalent.

The Binax NOW test is manufactured by Binax Inc., a subsidiary of Inverness Medical Innovations Inc. of Scarborough, Me.

For more information on malaria consult CDC at www.cdc.gov/malaria/.

• Refererence:
• FDA Clears for Marketing First Quick Test for Malaria

FDA Issues Dietary Supplements Final Rule

• Fri, 22 Jun 2007 16:30:00 GMT

The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a qualitymanner, do not contain contaminants or impurities, and are accurately labeled.

"This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA."

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Robert E. Brackett, Ph.D., director of FDA'sCenter for Food Safety and Applied Nutrition.

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

The final rule includes flexible requirements that can evolve with improvements in scientific methods used for verifying identity, purity strength, and composition of dietary supplements.

As a companion document, FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing of specific dietary ingredients used in the processing of dietary supplements.

Under the interim final rule the manufacturer may be exempted from the dietary ingredient identity testing requirement if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. FDA is soliciting comment from the public on the interim final rule. There will be a 90-day comment period, ending on September 24, 2007. Comments may be addressed to the Division of Dockets Management Branch at www.fda.gov/dockets/ecomments.

The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with more than 500 employees have until June 2008 to comply, companies with less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

Backgrounder: http://www.cfsan.fda.gov/~dms/dscgmps7.html

Fact Sheet: http://www.cfsan.fda.gov/~dms/dscgmps6.html

To see a consumer article called "Final Rule Promotes Safe Use of Dietary Supplements," visit http://www.fda.gov/consumer/updates/dietarysupps062207.html.

• Refererence:
• FDA Issues Dietary Supplements Final Rule

FDA Approves First Drug for Treating Fibromyalgia

• Thu, 21 Jun 2007 20:08:00 GMT

The U.S. Food and Drug Administration today approved Lyrica (pregabalin), the first drug to treat fibromyalgia, a disorder characterized by pain, fatigue and sleep problems.

Lyrica reduces pain and improves daily functions for some patients with fibromyalgia.

"Today's new approval marks an important advance, and provides a reason for optimism for the many patients who will receive pain relief with Lyrica," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "However, consumers should understand that some patients did not experience benefit in clinical trials. We still have more progress to make for treatment of this disorder."

Persons with fibromyalgia typically experience long-lasting or chronic pain, as well as muscle stiffness and tenderness. Fibromyalgia affects about 3 million to 6 million people in the United States each year. The disorder mostly affects women and typically develops in early-to-middle adulthood.

There is no test for the diagnosis of fibromyalgia. Doctors make a diagnosis by conducting physical examinations, evaluating symptoms, and ruling out other conditions.

Individuals with fibromyalgia have been shown to experience pain differently from other people. Studies have shown that such patients have decreased pain after taking Lyrica, but, the mechanism by which Lyrica produces such an effect is unknown.

Two double-blind, controlled clinical trials, involving about 1,800 patients, support approval for use in treating fibromyalgia with doses of 300 milligrams or 450 milligrams per day.

The most common side effects of Lyrica include mild-to-moderate dizziness and sleepiness. Blurred vision, weight gain, dry mouth, and swelling of the hands and feet also were reported in clinical trials. The side effects appeared to be dose-related. Lyrica can impair motor function and cause problems with concentration and attention. FDA advises that patients talk to their doctor or other health care professional about whether use of Lyrica may impair their ability to drive.

Lyrica already is approved for treating partial seizures, pain following the rash of shingles and pain associated with diabetes nerve damage (diabetic neuropathy).

Lyrica is manufactured by New York-based Pfizer Inc. Pfizer has agreed to perform a study of the drug in children with fibromyalgia and a study in breastfeeding women.

To see a consumer article called Living with Fibromyalgia, First Drug Approved, visit
www.fda.gov/consumer/updates/fibromyalgia062107.html

• Refererence:
• FDA Approves First Drug for Treating Fibromyalgia

Food and Drug Administration Press Releases

• 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:
• Food and Drug Administration Press Releases

Food and Drug Administration Press Releases

• 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:
• Food and Drug Administration Press Releases