FDA Alert News December 2007

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Food and drug administration press release for december 2007

FDA Alert News December 2007
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Food and Drug Administration Press Releases

The Food and Drug Administration today announced that it will be extending the comment period on the agency's proposed sunscreen regulation to Dec. 26, 2007. The comment period was set to expire on Nov. 26. Typically, comment periods for Federal rules is 90 days. The sunscreen rule, when finalized, will amend the 1999 FDA final rule on sunscreen products that protect against ultraviolet B (UVB) rays and incorporates new testing and labeling requirements for products that protect against ultraviolet A (UVA) rays.

On Aug. 27 the agency released to the public its proposed rule for over-the-counter (OTC) sunscreen products. FDA received nine requests to extend the comment period. One asked for an additional two months, eight for an additional nine months. The submissions cited the need for more time to complete laboratory testing and consumer studies on the proposed labeling system. By extending the comment period for 30 days, FDA is balancing industry concerns and the interests of public health to ensure that sunscreen products properly inform consumers of the level of protection they provide against UVA and UVB rays.

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 OTC drug products:
www.fda.gov/cder/Offices/OTC/consumer.htm

FDA Approves Zyrtec for Nonprescription Use in Adults and Children

The U.S. Food and Drug Administration has approved tablet, chewable tablet, and syrup formulations of Zyrtec (cetirizine HCl) for nonprescription use. The nonprescription drug is approved for the temporary relief of symptoms due to hay fever or other respiratory allergies (sneezing; runny nose; itchy, watery eyes; itchy throat or nose) in adults and children 2 years of age and older.  

The nonprescription Zyrtec products also are approved for the relief of itching due to hives in people 6 years of age and older, including adults.

"The approval of Zyrtec for nonprescription use offers an additional treatment option for children and adults," said Andrea Leonard-Segal, M.D., director, Division of Nonprescription Clinical Evaluation in the FDA's Center for Drug Evaluation and Research. "As for all nonprescription drugs, consumers and caregivers should read and carefully follow all directions on the labeling."

The tablets and chewable tablets are approved for adults and children 6 years of age and older:

The syrup is approved for:

The company will market two distinct Zyrtec products for each dosage form. One will provide directions for treating the symptoms of hay fever and other respiratory allergies. The other will contain directions for use to relieve the itching due to hives.

Zyrtec may cause drowsiness in some people at recommended doses. Other common side effects include fatigue and dry mouth. 
 
On November 9, 2007, the FDA announced that it had approved Zyrtec-D, a product which contains cetirizine HCl and pseudoephedrine HCl, for nonprescription use. Sales of the Zyrtec-D are subject to restrictions in the Combat Methamphetamine Epidemic Act. This law places restrictions on the sale of products containing pseudoephedrine, such as limiting the amount that an individual can purchase, and imposing record keeping requirements on the retail establishments that sell the product and that it be located with the pharmacist. Nonprescription Zyrtec-D was approved for the relief of symptoms due to hay fever or other upper respiratory allergies such as runny nose, sneezing, itchy, watery eyes, itching of the nose or throat, and nasal congestion. Zyrtec-D is also approved for reducing swelling of nasal passages, for relief of sinus congestion and pressure, and for restoring freer breathing through the nose due to hay fever and other upper respiratory allergies. Zyrtec-D is not approved for the relief of itching due to hives. 

Zyrtec is marketed and distributed by McNeil Consumer Healthcare, based in Fort Washington, Pa.

FDA Issues Early Communication for Chantix

Background: The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Chantix, a drug approved as an aid to smoking cessation treatment. An Early Communication reflects FDA’s current analysis of available data concerning these drugs and does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue.

FDA is evaluating postmarketing adverse event reports for Chantix (varenicline), a prescription medicine to help adults stop smoking.

Based on FDA’s request for information from the manufacturer, Pfizer, Inc., the company recently submitted reports to the agency describing suicidal ideation (thoughts). In the wake of a case report citing erratic behavior in an individual who had used Chantix, FDA has also asked the company for any information on additional cases that may be similar in patients who have taken the drug.

FDA’s Center for Drug Evaluation and Research is working to complete an analysis of the available information and data. When this analysis is completed, FDA will communicate the conclusions and recommendations to the public.

In the meantime, FDA recommends that health care providers monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes.

FDA also advises that, due to reports of drowsiness, patients should use caution when driving or operating machinery until they know how using Chantix may affect them.

Full text of the Early Communication about the Ongoing Safety Review can be found at: http://www.fda.gov/cder/drug/early_comm/varenicline.htm.

FDA Approves Nexavar for Patients with Inoperable Liver Cancer

The U.S. Food and Drug Administration today announced that it has approved Nexavar (sorafenib) for use in patients with a form of liver cancer known as hepatocellular carcinoma, when the cancer is inoperable. Nexavar was originally approved in 2005 for the treatment of patients with advanced renal cell carcinoma, a form of kidneycancer.

"In a randomized clinical trial, the group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn't receive the drug,” said Robert Justice, M.D., director of FDA's division of drug oncology products. "This is an important new treatment option for patients who are fighting this very difficult form of cancer."

According to the National Library of Medicine, hepatocellular carcinoma accounts for 80 to 90 percent of all liver cancers. This type of cancer can be difficult to remove completely using surgery. If all of the cancer cannot be removed, the disease is usually fatal within three to six months. The American Cancer Society estimates that there will be 19,160 new cases and 16,780 deaths from cancer of the liver and intrahepatic bile duct in the United States in 2007.

Nexavar is a type of anticancer drug called a kinase inhibitor. It interferes with molecules that are thought to be involved in chemical messages sent within cancer cells, in the formation of blood vessels that supply tumors, and in cell death.

FDA's approval of Nexavar was based on the results of an international randomized placebo-controlled trial in patients with inoperable hepatocellular carcinoma. The study was designed to compare the survival of a group of patients who received the drug against a group of similar patients who did not.

A total of 602 patients were studied. Each patient received Nexavar or a placebo. Both groups were comparable with regard to age, gender, race, the stage and other characteristics of their cancer, and the types of cancer treatment they had received before entering the clinical trial.

The trial was stopped after a planned interim analysis showed a statistically significant advantage in overall survival for the patients who had received Nexavar. Patients who received Nexavar survived a median of 10.7 months while patients who received placebo survived a median of 7.9 months. A separate analysis showed that tumors progressed more slowly in patients who received Nexavar compared to patients who had received placebo.

The most common adverse reactions that have been observed in patients taking Nexavar (for hepatocellular carcinoma or renal cell carcinoma) are fatigue, weight loss, rash or superficial skin shedding, hand or foot skin reaction, hair loss, diarrhea, anorexia, nausea and abdominal pain. Twenty percent or more of patients had experienced at least one of these reactions. In patients with hepatocellular carcinoma, diarrhea was reported in 55 percent of patients who received Nexavar. Inadequate blood supply to the heart or heart attack were reported in 2.7 percent of patients who received Nexavar, compared to 1.3 percent for patients who received placebo. New high blood pressure was reported in 9 percent of patients who received Nexavar, compared to 4 percent of patients who received placebo.

Elevated serum lipase, an enzyme that measures liver function, occurred in 40 percent of patients who received Nexavar, compared to 37 percent of patients who received placebo, and hypophosphatemia, or low blood levels of phosphate, occurred in 35 percent of patients who received Nexavar, compared to 11 percent of patients who received placebo.

Nexavar comes in 200 milligram tablets and the usual dose is two tablets (400 milligrams) taken twice a day on an empty stomach.

Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany for Bayer Pharmaceuticals Corporation, West Haven, Conn. and by Onyx Pharmaceuticals, Inc., Emeryville, Calif.

FDA Awards Grants to Further Food Safety

The U.S. Food and Drug Administration's Office of Regulatory Affairs (ORA) today announced the award of three lab grants, designed to boost the food screening capabilities and spot radioactive material in food, resulting from deliberate or accidental contamination. These labs are partof the Food Emergency Response Network (FERN).

The three-year grants provide $250,000 a year for supplies, personnel, minor facility upgrades and training. Recipients of the grants are the Texas Department of State Health Services Laboratory, the New York Health Research/New York Department of Health, and the Wisconsin State Laboratory of Hygiene.

FDA's ORA will expand its testing program to address the threat to food safety through radiological terrorism events. ORA has developed radiological screening and analysis methodologies used to evaluate foods and food products.

The grants are targeted toward enhanced detection of radiological contamination and thus enhance the nation's overall capability to rapidly detect and respond to deliberate attacks on the food supply.

The grant awards further expand the FDA's ability to promote the integrated strategy for protecting the nation's food supply through the three core elements of prevention, intervention, and response, as outlined in the agency's Food Protection Plan. These funded labs will be involved in food defense surveillance testing as well as bolstering the FDA's emergency response efforts by increasing the capacity for testing of foods for radioactive contamination, intentional or accidental.

The selected laboratories will receive funds to assist in acquiring supplies, personnel, and facility upgrades. The labs will receive training in current food testing methodologies, participate in method development and validation, proficiency testing, and food defense surveillance assignments.

Two key project areas have been identified for the grant recipients. These areas involve the detection of radioactive contamination, utilizing the most advanced detection systems available.

FERN's mission is to integrate the nation's food-testing laboratories at the local, state, and federal levels into a network able to respond to emergencies involving biological, chemical, or radiological food contamination. The network can respond to emergencies related to agents in food and restore the public's confidence in the food supply.

Approximately $2 Million of Potentially Harmful "Cosmetic" Eye Product Seized

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized today 12,682 applicator tubes of Age Intervention Eyelash, a product that may, in some users, lead to decreased vision. Authorities said the sales value ofthe seized tubes is approximately $2 million.

Age Intervention Eyelash is sold and distributed by Jan Marini Skin Research, Inc., of San Jose, Calif.

The FDA considers Age Intervention Eyelash to be an unapproved and misbranded drug because Jan Marini Skin Research has promoted the product to increase eyelash growth. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA. The agency takes seriously its responsibility to protect Americans from unapproved drugs.

FDA also considers the seized Age Intervention Eyelash to be an adulterated cosmetic. The product contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye).

For patients using the prescription drug, using the Age Intervention Eyelash in addition to the drug may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug's effectiveness. Damage to the optic nerve may lead to decreased vision and possibly blindness.

In addition, use of Age Intervention Eyelash may cause other adverse effects in certain people due to the bimatoprost, including macular edema (swelling of the retina) and uveitis (inflammation in the eye), which may lead to decreased vision.

The U.S. Attorney's Office for the Northern District of California filed the complaint requesting the seizure, and coordinated with the FDA. The California Department of Public Health‘s Food and Drug Branch had previously embargoed the seized products at the San Jose facility. Jan Marini Skin Research has notified FDA that the company ceased manufacturing and shipping any Age Intervention Eyelash product containing bimatoprost last year.

The FDA recommends that consumers, dermatologists, and estheticians who may still have Age Intervention Eyelash discontinue using it and discard any remaining product. FDA also recommends that consumers consult their health care provider if they have experienced any adverse events that they suspect are related to the product's use.

FDA Announces Board Members of Reagan-Udall Foundation

The U.S. Food and Drug Administration (FDA) today announced the board members and chair of the Reagan-Udall Foundation. The private and independent nonprofit organization will advance FDA's mission to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.

"The Reagan-Udall Foundation will be an important and independent vehicle for furthering the mission of FDA. By supporting public-private partnerships and other scientific collaborations, the foundation will enrich the agency and provide critical perspectives for the future," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "As FDA looks toward its future, the Reagan-Udall Foundation is in a unique position to understand, support and prepare the agency for that future."

"This foundation brings together an extraordinary group of leaders with diverse talents and experiences. The board members' combined backgrounds reflect the transformation and vision of FDA," said von Eschenbach.

In a demonstration of bipartisan support, the U.S. Congress mandated the foundation's creation in the Food and Drug Administration Amendments Act, passed in September 2007. The law requires that the foundation board of directors be established within 30 days and that it not include any federal employee.

Mark McClellan, M.D., Ph.D., director of the Engleberg Center for Health Care Reform at the Brookings Institution, former commissioner of FDA and former administrator of the Centers for Medicare and Medicaid Services, will chair the foundation.

McClellan said, "The foundation is an unprecedented opportunity to enlist broad-based support to accelerate scientific progress to help FDA fulfill its mission of protecting and promoting the public health—a mission that is more challenging but more important than ever."

"I look forward to a collaborative partnership with the board, the agency, legislators, and stakeholders to accelerate innovation that will improve the quality and safety of medical and food products," said McClellan.

In addition to McClellan, the new board members are:

"By agreeing to serve on the board, these distinguished representatives will help FDA continue to bridge scientific discovery into the development of safe and effective products," said von Eschenbach. "They reflect the areas served by FDA, all of which have a stake in a transparent and collaborative process. The broad representation from science, academia and industry in addition to strong Congressional support for this foundation is indicative of its mission, which will be about building the science of product safety."

The statute calls for a 14-member board: four representatives from the general pharmaceutical, device, food, cosmetic, and biotechnology industries; three from academic research organizations; two from patient or consumer advocacy groups; one representing health care providers; and four at-large representatives with expertise or experience relevant to the foundation's purpose.

In addition, a majority of the foundation's board members—nine out of 14—must be appointed from a list of candidates provided by the National Academy of Sciences and the remaining five from nominations submitted by patient and consumer advocacy groups, professional scientific and medical societies and industry trade organizations.

As required by statute, four government health care officials—the commissioner of the FDA, the director of the National Institutes of Health, the director of the Centers for Disease Control and Prevention, and the director of the Agency for Health Care Research and Quality—appointed the board members from the two lists of candidates. The FDA commissioner and NIH director will continue participating in foundation activities as non-voting board members.

Congress established the Reagan-Udall Foundation to identify and address unmet scientific needs in the development, manufacture and evaluation of the safety and effectiveness of FDA-regulated products, including post-market evaluation. The foundation will establish scientific projects and programs to address those needs and help accomplish the scientific work FDA needs to support its regulatory mission.

FDA Announces Steps to Improve Advisory Committee Processes

The Food and Drug Administration is announcing several steps to strengthen its advisory committee processes in ways consistent with recommendations of the Institute of Medicine. The measures include proposed new guidance or procedures on advisory committee voting, on disclosing information on conflicts of interest, and on security and appropriate conduct for participants at meetings. Other improvements include greater clarity to FDA’s advisory committee Web site, which can be found at http://www.fda.gov/oc/advisory/default.htm.

“One of FDA’s strengths is that we routinely enlist the nation’s leading experts to give us public advice on complex medical and scientific issues,” said Randall Lutter, Ph.D., deputy commissioner for policy. “The new steps we’re taking further enhance the transparency and reliability of our advisory committee processes.”

A draft guidance document being issued today recommends advisory committees adhere to a process of simultaneous voting, in which all members vote at once. The results of the vote would be announced immediately. How each member voted would be part of the public record. The draft guidance document is available at http://www.fda.gov/oc/advisory/votingguidance.html.

A second draft guidance issued recently lays out recommended changes to the process of public disclosure of financial interests that create conflicts of interest for advisory committee members. The new draft guidance makes the process more transparent and consistent by having all advisory committee members publicly disclose interests for which a waiver is granted. The draft guidance also includes redesigned disclosure and waiver templates that are clearer and easier for the general public to understand. The draft guidance document and redesigned templates are available at http://www.fda.gov/oc/advisory/waiver/ACdisclosure1007.html.

FDA also has formalized operating procedures designed to ensure appropriate security and promote proper decorum and public conduct at advisory committee meetings. They are intended to help ensure that meetings proceed in an orderly fashion and that the work of the committees is not impeded, but that the right of free speech is also protected.

In addition, FDA has improved its Web page on advisory committees by providing better access to information about waivers granted for conflicts of interest. This Web page provides current information about upcoming advisory committee meetings and other updated information related to FDA's advisory committee processes. The Web site is at http://www.fda.gov/oc/advisory/default.htm.

Finally, the FDA has recently posted the names of outside experts that it has named to a new risk communication advisory committee to make recommendations to FDA about how best to communicate the risks and benefits of FDA regulated products. More information about this advisory committee and the list of members can be found at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01739.html.

FDA’s policies on advisory committees continue to be informed by new studies on conflicts of interest. The agency asked a consultant, Eastern Research Group, to study 16 recent advisory committees. The report highlights the difficulty of assembling highly qualified experts who are free of conflicts and finds that those who have received waivers appear to be significantly more qualified than those who have not received waivers. The full report is available online at http://www.fda.gov/oc/advisory/ERGCOIreport.pdf.

So far this year the agency has convened 47 meetings of expert independent advisory committees to advise FDA on topics such as new gene therapies and the safety of children’s cough and cold medicines.

FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia

The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks.

People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.

"FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "FDA remains committed to making sure that doctors and patients have the latest information about the risks and benefits of medicines."

Avandia, manufactured by GlaxoSmithKline (GSK), Philadelphia, Pa., was approved in 1999 as an adjunct to diet and exercise to improve control of blood sugar levels. Avandia is approved to be used as a single therapy or used in combination with metformin and sulfonylureas, other oral anti-diabetes treatments.

During the past year, FDA has carefully weighed several complex sources of data, some which show conflicting results, related to the risk of chest pain, heart attacks and heart-related deaths, and deaths from any cause in patients treated with Avandia.

At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Therefore, FDA has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent. GSK has agreed to conduct the study and FDA will ensure it is initiated promptly.

The revision of Avandia's existing boxed warning – FDA's strongest form of warning – includes the following statement:

A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.

The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients.
GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia.

To date, no oral anti-diabetes drug has been conclusively shown to reduce cardiovascular risk. Consequently, the agency also will be requesting that labeling of all approved oral anti-diabetes drugs contain language describing the lack of data showing this benefit.

Today's action follows recommendations made at the July 2007 joint meeting of FDA's Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling.

For more information:
Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm

FDA Issues Safety Alert on Avandia
www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html

FDA Approves Nonprescription Zyrtec-D for Allergies

The Food and Drug Administration (FDA) has approved Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg), an allergy drug, for nonprescription use in adults and children 12 years of age and older. This drug combines an antihistamine with a nasal decongestant.

Available as a prescription drug since 2001, Zyrtec-D is now approved as a nonprescription drug for the relief of symptoms due to hay fever or other upper respiratory allergies such as, runny nose, sneezing, itchy, watery eyes, itching of the nose or throat, and nasal congestion. Zyrtec-D is also for reducing swelling of nasal passages, for relief of sinus congestion and pressure, and for restoring freer breathing through the nose.

Hay fever and other allergies are the sixth leading cause of chronic disease, with about 50 million sufferers each year in the United States, according to the National Institute of Allergy and Infectious Diseases.

"The approval of this widely-used drug for nonprescription use will enable many people to have access to another effective treatment for their allergy symptoms," said Andrea Leonard-Segal, M.D., director, Division of Nonprescription Clinical Evaluation in the FDA"s Center for Drug Evaluation and Research. "This approval reflects FDA's commitment to bringing prescription drugs to the over-the-counter market when they can be safely used without a prescription.

Zyrtec-D"s common side effects include drowsiness, fatigue, and dry mouth. Sales of the drug are subject to restrictions in the Combat Methamphetamine Epidemic Act. This law places restrictions on the sale of products containing pseudoephedrine, such as limiting the amount that an individual can purchase, and imposing record keeping requirements on the retail establishments that sell the product. Zyrtec-D is distributed by McNeil Consumer Healthcare, Fort Washington, Pa.

For more information:

Allergies and Hay Fever Fact Sheet
www.fda.gov/womens/getthefacts/allergies.html

FDA Consumer Magazine: "Itching for Some Allergy Relief?"
www.fda.gov/fdac/features/2002/302_itch.html

FDA Clears Silver-Coated Breathing Tube for Marketing

The U.S. Food and Drug Administration today announced that it has cleared for marketing a breathing tube coated with a thin layer of silver. The coating, a material known to have antimicrobial properties, reduces the risk that patients on ventilators will acquire pneumonia while in the hospital.

The Agento endotracheal tube, manufactured by C.R. Bard Inc., is intended for patients who must rely on a ventilator to breathe for 24 hours or more.

Patients requiring such a breathing support system are at risk of exposure to hospital-acquired bacteria that can build up on the breathing tube or pass through the tube to their lungs, eventually causing a lung infection known as ventilator-associated pneumonia (VAP).

Fifteen percent of the patients on ventilators develop VAP every year and 26,000 die from the infection, according to the Centers for Disease Control and Prevention.

"Patients who require ventilator support are at increased risk for pneumonia, which poses a significant public health issue. This product can help to lower this risk," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health.

Silver has been known for its antimicrobial properties for decades and has been used for this purpose on several types of devices. This is the first endotracheal tube coated with silver. 

In a multicenter clinical trial comparing the Agento breathing tube to an uncoated tube, the percentage of patients who developed pneumonia was reduced from 7.5 percent to 4.8 percent. The Agento also delayed the onset of pneumonia.

The FDA in July issued a proposed guidance document on antimicrobial device submissions stating that when companies claim their product reduces or prevents device-related infections, the claim should be supported by such clinical data.

C.R. Bard is located in Murray Hill, N.J.

FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents (ESAs)

The U.S. Food and Drug Administration today approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with chronic kidney failure.

The labeling changes, which incorporate advice from FDA advisory committees and expand upon labeling changes made in March 2007, also include a statement that symptoms of anemia, fatigue and quality of life have not been shown to improve in patients with cancer who are treated with ESAs.

Epogen, Procrit and Aranesp are approved to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in certain patients with cancer. Epogen and Procrit are also approved for use in certain patients with anemia who are scheduled to undergo major surgery to reduce blood transfusions during or shortly after surgery and for the treatment of anemia caused by zidovudine (AZT) therapy in HIV patients.

For Patients with Cancer

For patients with cancer, the new boxed warnings emphasize that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater.

The boxed warnings also emphasize that no clinical data are available to determine whether there is a similar risk of shortened survival or increased tumor growth for patients with cancer who receive an ESA dose that attempts to achieve a hemoglobin level of less than 12 g/dL. This is the hemoglobin level commonly achieved in clinical practice.

Health care providers determine whether a patient is anemic and decide on ESA dosing by measuring how much of the protein known as hemoglobin is present in a patient's red blood cells.

An earlier boxed warning, approved in March, described the results of six studies demonstrating that survival was shorter and tumors progressed faster when ESAs were used to achieve hemoglobin levels of 12 g/dL or greater in cancer patients.

Today's new boxed warning also clarifies that ESAs should only be used in patients with cancer when treating anemia specifically caused by chemotherapy and not for other causes of anemia. Moreover, it states that ESAs should be discontinued once the patient's chemotherapy course has been completed.

"Health care professionals need to consider the risks of increased tumor progression and decreased survival in patients with cancer when prescribing ESAs," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer and acting director of its Center for Drug Evaluation and Research. "ESAs should be used in patients with cancer only when their anemia is due to chemotherapy and only at the lowest dose necessary to avoid the need for blood transfusions."

The FDA is working with the manufacturer to design and conduct clinical trials of different dosing regimens and tumor types to further characterize potential tumor progression associated with ESAs.

For Patients with Chronic Kidney Failure

For patients with chronic kidney failure, the new boxed warning states that ESAs should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk for death and for serious cardiovascular reactions such as stroke, heart attack or heart failure, the boxed warning states.

In addition to the boxed warning, the new labeling provides specific instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment with an adequate increase in their hemoglobin levels.

The new labeling also emphasizes that there are no data from controlled trials demonstrating that ESAs improve symptoms of anemia, quality of life, fatigue, or patient well-being for patients with cancer or for patients with HIV undergoing AZT therapy.

In March 2007 the FDA approved labeling changes and issued a public health advisory outlining the new safety information about ESAs. Safety concerns regarding ESAs were discussed during May 2004 and May 2007 meetings of FDA's Oncologic Drug Advisory Committee and a September 2007 joint meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. ESA product labeling was previously revised in 1997, 2004 and 2005 to reflect new safety information.

The agency is currently reviewing a proposed Medication Guide that will better communicate the safety and effectiveness of ESAs to patients and will replace the existing patient labeling.

ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. These drugs are manufactured by Amgen Inc., Thousand Oaks, Calif. Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, N.J, a subsidiary of Johnson & Johnson.

For more information: http://www.fda.gov/cder/drug/infopage/RHE/default.htm

FDA Selects Members for Risk Communication Advisory Committee

The U.S. Food and Drug Administration has selected 15 voting members to serve on its Risk Communication Advisory Committee. The Committee will advise FDA about how best to communicate to the public about the risks and benefits of FDA-regulated products so as to facilitate their optimal use.

On June 5, 2007 FDA announced the establishment of the advisory committee and requested nominations for qualified individuals to serve as members. The agency received more than 240 nominations, many for exceptionally qualified individuals.

The establishment of the advisory committee was one of the recommendations of the Institute of Medicine’s 2006 report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public."

"Communicating effectively about the safety and effectiveness of drugs and other medical products is one of the central roles of FDA," said Randall Lutter, Ph.D., Deputy Commissioner for Policy. "We were in such strong agreement about the value of the Risk Communication Advisory Committee that we expanded its scope to address communication regarding all products regulated by the agency, including our food supply responsibilities."

The advisory committee’s 15 voting members include independent experts and public members. Experts were chosen from the fields of risk communication, risk perception, decision analysis, communication, social marketing, health literacy, journalism, and other behavioral and social sciences. Public members include those who can provide the perspective of users of FDA-regulated products, such as consumers, patients, caregivers and health care providers. For some meetings, one or more industry representatives may be invited to participate in a nonvoting capacity.

Members have been assigned to serve for periods ranging from one to four years. FDA expects to hold the committee’s first meeting in the first quarter of 2008. The list of members is available on FDA’s Web site at http://www.fda.gov/oc/advisory/OCRCACRoster.htm.

FDA is currently amending the committee’s charter to incorporate the provisions of the recently passed Food and Drug Administration Amendments Act of 2007.

FDA Requests Marketing Suspension of Trasylol

The U.S. Food and Drug Administration (FDA) today announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.

FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.

There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.

Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.

Two weeks ago, FDA was notified that researchers with the Ottawa Health Institute stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The preliminary data from this terminated study also suggested that fewer patients receiving the drug experienced serious bleeding events.

On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to the Canadian study's termination. In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.

FDA Requests Recall of 'True Man Sexual Energy,' 'Energy Max' Dietary Supplements

The U.S. Food and Drug Administration yesterday requested a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules, illegal drug products that contain potentially harmful, undeclared ingredients. The products, often advertised as ``all natural'' alternatives to approved erectile dysfunction drugs, could interact with medications and cause dangerously low blood pressure. They contain substances that have similar structures to active ingredients in approved prescription drugs.

The FDA has not approved True Man or Energy Max, and their safety and effectiveness are unknown.

The FDA requested the recall of all products distributed under both labels in a letter to Yin Kao, president and owner of America True Man Health Inc., of West Covina, Calif.

The products are often advertised in newspapers, retail stores, and on the Internet.

“The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure," said Janet Woodcock, M.D., deputy commissioner for scientific and medical programs, chief medical officer and acting director of the FDA’s Center for Drug Evaluation and Research.

As formulated, True Man Sexual Energy and Energy Max are classified as unapproved new drugs that do not declare the active ingredients thione, an analog of sildenafil; or piperadino vardenafil, an analog of vardenafil. Analogs may cause side effects and drug interactions similar to the approved drugs they resemble.

The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

The FDA issued an alert on May 10, 2007, (http://www.fda.gov/bbs/topics/NEWS/2007/NEW01633.html) advising consumers not to buy or use True Man or Energy Max products. Today’s recall request comes as a result of the company previously failing to notify all of their consignees and involves True Man Sexual Energy packaged in blister pack cartons of 10 capsules and Energy Max packaged in blister pack cartons of 20 capsules. FDA is prepared to take further regulatory action should the firm refuse to accede to this request.

FDA chemical analysis has shown that Energy Max contains thione, an analog of sildenafil, a substance similar to the active ingredient in the approved ED drug Viagra. In addition, FDA investigators found that True Man contains the same analog or an analog of vardenafil, the active ingredient Levitra, another approved ED treatment. Neither of the analogs used in True Man or Energy Max are components of FDA-approved drug products.

Customers who have either product in their possession should stop using it immediately and contact their health care provider if they have experienced any problems that may be related to taking this product.

Consumers should 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

Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787

More than $300,000 of Drugs and Dietary Supplements Seized

At the request of the U.S. Food and Drug Administration, on Wednesday, U.S. Marshals seized more than $300,000 worth of product, including NC Solution, an antifungal product, and other drugs for human or animal use, dietary supplements, and ingredients to make those products because some lacked FDA approval and all were maintained under grossly unsanitary conditions by General Therapeutics Corp., of St. Louis, Mo.

The FDA considers NC Solution to be a drug because it is intended for the use in the diagnosis, cure, or treatment of disease in people or animals. NC Solution is also a new drug because it is not generally recognized as safe and effective for its intended uses.

Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by the FDA. The company does not have approval for NC Solution.

“The action taken Wednesday is the culmination of the concerted efforts by the FDA to get the firm to follow the law when it comes to manufacturing safe products for consumers,” said Margaret O'K. Glavin, FDA Associate Commissioner for Regulatory Affairs.

In August and September, FDA inspectors found that the company was still manufacturing drugs and dietary supplements under unsanitary conditions, including insects and rodent filth on and around manufacturing equipment, despite a warning by FDA of serious violations in 1999. Following the 1999 inspection, a company official told the FDA in January, 2000, it would stop manufacturing drugs.

The FDA recommends that consumers who have any products manufactured by General Therapeutics, including NC Solution, consult their health care provider about discontinuing use and if they have experienced any adverse events that they suspect are related to the product's use.

Catherine L. Hanaway, U.S. Attorney for the Eastern District of Missouri, filed the complaint requesting the seizure, and her office will continue to coordinate with the FDA to ensure proper disposal of the seized items.

The FDA's action against the company is consistent with the agency's initiative on unapproved drugs which pose potentially harmful risks to consumers.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration today announced a new e-mail service that alerts subscribers whenever information is updated on certain FDA Web pages.

The service is free and available for a wide variety of FDA's Web pages, including food safety protection, medical product approvals and consumer health information.

"Being able to directly communicate with consumers, health care professionals and the regulated industry about the safety of our food supply and medical products is critical to FDA's ongoing commitment to protecting the public health," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "E-mail is the leading use of the Internet, and this service strengthens FDA's ability to keep its audiences informed quickly and effectively."

To receive e-mail alerts, subscribers need only click on the red envelope icon located on participating Web pages. Each e-mail update includes a direct link to the FDA Web page that has been updated.

Powered by GovDelivery, a private sector e-mail subscription management system used by several other federal agencies, the service allows subscribers the flexibility to personalize the information most important to them.

A full list of currently available topics can be found at www.fda.gov/emaillist.html).

Food and Drug Administration Press Releases

Background: On May 29, 2007 AstraZeneca, the maker of Prilosec (omeprazole) and Nexium (esomeprazole), sent FDA data from two long-term studies in patients with severe gastroesophageal reflux disease (GERD) that were being treated with either Prilosec or Nexium.  The studies were designed to assess the effectiveness of treatment with Prilosec, or Nexium, or surgery for severe GERD.  Participants were randomly assigned to receive treatment with either a drug (Prilosec in one study and Nexium in the other) or surgery. During the studies, cardiovascular events raised a question about whether  long-term use of these drugs increases the risk of heart attacks, heart failure, and heart-related sudden death in patients taking either one of the prescribed drugs compared to patients who received surgical treatment.  On Aug. 9, 2007 FDA released an "Early Communication of an Ongoing Safety Review" of these drugs.  The agency’s initial review determined that there was no increased risk of heart problems associated with long-term use of these drugs.  At FDA’s request, AstraZeneca submitted a large amount of additional information about these and other studies and FDA undertook a comprehensive review of all available data regarding this potential safety concern.  The following represents the agency’s current analysis of available data on these medications.

Current Information:  FDA has completed a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium.  While both of the long-term studies reported to FDA on May 29, 2007 collected safety data, the study protocols did not specify how heart problems, such as heart attacks, were defined or verified.  As a result, evaluating the information that was gathered about the safety of both drugs in these studies was challenging.  FDA’s assessment of the information from the data gathered was further supported by an additional analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled.  Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with the use of Prilosec or its newer formulation Nexium.

Based on everything now known at the agency, the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of the two small long-term studies does not indicate the presence of a true effect. Therefore, FDA continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems.  FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs.

About Prilosec and Nexium

Prilosec and Nexium are members of a class of drugs known as proton pump inhibitors (PPIs). Nexium (esomeprazole)  is the newer formulation of the original Prilosec (omeprazole) product. As prescription products, they are used to treat the symptoms of GERD and other conditions caused by excess stomach acid. PPIs work to decrease the amount of acid produced in the stomach and help heal erosions in the lining of the esophagus known as erosive esophagitis. They are also indicated for use with an antibiotic to treat gastric ulcers. Prilosec is also available as an over-the-counter medication to treat frequent heartburn.

To read a summary of what FDA knows about the data, visit:
www.fda.gov/cder/drug/early_comm/omeprazole_esomepazole_update.htm

To read the Early Communication visit:
http://www.fda.gov/cder/drug/early_comm/omeprazole_esomeprazole.htm

To report serious adverse reactions visit:
www.fda.gov/medwatch/report/hcp.htm

Or write to:
5600 Fishers Lane
Rockville, MD  20853-9787
Or Call: 1-800-FDA-1088

 

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration today announced that the manufacturers of drugs containing the active ingredient carbamazepine have agreed to add to the drugs' labeling a recommendation that, before starting therapy with the drugs, patients with Asian ancestry get a genetic blood test that can identify a significantly increased risk of developing a rare, but serious, skin reaction.

Carbamazepine is a drug used for treatment of epilepsy, bipolar disorder, and neuropathic pain. It is sold under the brand names Carbatrol, Equetro and Tegretol.

"Science is now letting us individually treat patients based on how their body might react to a drug," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "When being considered for treatment with carbamazepine, genetically high-risk patients can be given a test that will help their health care providers make personalized drug treatment decisions and help avoid potentially serious skin reactions."

The prescribing information for these drugs already includes a warning that for all patients starting carbamazepine therapy, regardless of ethnicity, rare but severe and sometimes life-threatening skin reactions can occur. These life-threatening skin reactions include toxic epidermal necrolysis and Stevens-Johnson syndrome, characterized by multiple skin lesions, blisters, fever, itching and other symptoms.

The risk of these reactions is estimated to be about 1 to 6 per 10,000 new users of the drug in countries with mainly white populations. However, the risk is estimated to be about 10 times higher in some Asian countries.

The skin reaction warnings will be moved to the current boxed warning section of the labeling. The new recommendation that health care providers give patients with Asian ancestry a genetic test before starting treatment will also be added to the boxed warning section.

To screen for this genetic marker, a patient's blood can be drawn by a health care provider and the test administered at a laboratory. It is estimated that about 5 percent of patients being considered for treatment with carbamazepine are of Asian ancestry and would need to have this test.

Studies have found a strong association between certain serious skin reactions and an inherited variant of a gene, HLA-B* 1502, an immune system gene, found almost exclusively in people with Asian ancestry. Patients testing positive for this gene should not be treated with carbamazepine unless the benefit clearly outweighs the increased risk of these serious skin reactions.

Patients who have taken carbamazepine for more than a few months and not experienced any skin reactions are unlikely to ever experience these reactions, regardless of ancestry or genetic test results. Patients currently taking carbamazepine who are concerned about these skin reactions should not stop taking the drug without first consulting their health care provider. 

Carbatrol is manufactured by Shire Pharmaceuticals, Wayne, Penn.; Equetro is manufactured by Validus Pharmaceuticals Inc., Parsippany, N.J.; and Tegretol is manufactured by Novartis, East Hanover, N.J. Generic versions of carbamazepine are available. 

For Information

FDA Information for Healthcare Professionals: Carbamazepine
www.fda.gov/cder/drug/InfoSheets/HCP/carbamazepineHCP.htm

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration is warning consumers not to use 3.5 oz. packages of Swad brand sindoor, an orange or red powder used in some traditional South Asian Pacific ceremonies that is applied to the face or scalp, imported by Raja Foods LLC of Skokie, Illinois because the product contains high levels of lead. Although the product was not intended to be sold for food use, its labeling is confusing and implies that it may be used as food. The Illinois Department of Public Health has confirmed two cases of lead poisoning in consumers who used the product as an ingredient in home cooked meals. Other uses of the product,including as a cosmetic, can also be dangerous due to the high lead levels.

Lead can be toxic to all humans but due to the risks it poses to a developingnervous system, women of childbearing age, pregnant women and their unborn children,and young children should be especially cautious and limit their exposure tolead. Symptoms of lead toxicity include: stomach aches, colic, nausea, vomiting,abnormal irritability, and insomnia. However, people with lead in their bloodoften do not exhibit symptoms. Permanent damage to the central nervous systemfrom lead exposure can result in learning difficulties in school children aswell as cause other long-term health problems such as kidney disease. Anyonewho has consumed this product should consult his or her health care providerimmediately.

At least 280 packages of Sindoor were distributed to grocery stores that specializein foods from India in Colorado, Georgia, Illinois, Indiana, Iowa, Kansas,Michigan, Minnesota, Missouri, Nebraska, New York, Ohio, Oregon, Tennessee, Texas,Washington, and Wisconsin.

The front label of the bag states "SWAD BEST TASTE IN TOWN SINDOOR", "FORRECIPE IDEAS VISIT OUR WEBSITE: WWW.RAJAFOODS.COM",and "PRODUCT OF INDIA." The back label states "Importedand Distributed by: Raja Foods, 8110, N. St. Louis Avenue, Skokie, ILL 60076",with a UPC of 0 51179 42236 0 and may have a sticker stating "NONEDIBLE".

Packages of Sindoor can be returned to the place of purchase for a full refund.Consumers with questions may contact the company at 1-800-800-7923 x 2860.

Consumers should report adverse events related to this product to MedWatch, the FDA’s voluntary reporting program: www.fda.gov/medwatch/report.htm,800-332-1088, fax: 800-332-0178, mail: MedWatch, Food and Drug Administration,5600 Fishers Lane, Rockville, MD 20852-9787.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration has approved Bystolic (nebivolol) for the treatment of high blood pressure.

Bystolic is a beta blocker, a well-established class of medications that reduces blood pressure by reducing the force with which the heart pumps. It is a new drug not previously approved in the United States.

Nearly one in three adults in the United States has high blood pressure, also called hypertension, which can increase the risks for stroke, heart failure, heart attack, kidney failure, and death. 

"High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body," said Douglas C. Throckmorton, M.D., FDA's deputy director of the Center for Drug Evaluation and Research. "Bystolic offers a new treatment option for people who need to control their high blood pressure."

The safety and efficacy of Bystolic in lowering blood pressure was assessed in three randomized, double-blind, multi-center, placebo-controlled clinical trials that ran for up to three months.  

A fourth placebo-controlled clinical trial demonstrated additional blood pressure-lowering effects when Bystolic was given with up to two other antihypertensive medications in patients with inadequate blood pressure control. In total, more than 2,000 people received Bystolic during the trials. Its efficacy during the trials was similar to those of other FDA-approved beta blockers.

The most common side effects reported by patients taking Bystolic in clinical trials were headache, fatigue, dizziness and diarrhea.  

Mylan Bertek Pharmaceuticals Inc. of Research Triangle Park, N.C., is the sponsor of Bystolic. New York City-based Forest Laboratories, Inc. owns the rights for the sales and marketing of the drug.

For more information
What is High Blood Pressure? — National Heart Lung and Blood Institute
www.nhlbi.nih.gov/health/dci/Diseases/Hbp/HBP_WhatIs.html

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) issued a final rule today that requires that manufacturers of over-the-counter (OTC) stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient nonoxynol 9 (N9) include a warning that the chemical N9 does not provide protection against infection from HIV (the virus that causes AIDS) or other sexually transmitted diseases (STDs).

Stand-alone spermicides include gels, foams, films, or inserts containing N9 that are used by themselves for contraception. Consumers can protect themselves from the transmission of STDs and HIV by practicing abstinence, being in a monogamous relationship where neither partner is infected, and using condoms consistently and correctly.

"FDA is issuing this final rule to correct misconceptions that the chemical N9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases, including HIV infection," said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research (CDER). "Clinical research has shown that N9 provides no protection against sexually transmitted diseases to the woman if her sexual partner is infected with an STD pathogen or HIV."

In addition, FDA is requiring that the labels warn consumers that the chemical N9 in stand-alone vaginal contraceptives and spermicides can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner.

In January 2003, FDA proposed new warning statements and other labeling information for these products after results from a major clinical study in Africa and Thailand showed that women using a contraceptive gel product containing N9 were not protected against HIV and other STDs and were at higher risk for HIV infection than women using a placebo gel. Because these and other studies have shown that use of products containing N9 cause vaginal and rectal irritation, which can heighten the chance of becoming infected with HIV from an infected partner, FDA's action is based on the need to protect the public health and empower consumers to make better informed decisions about the use of these products.

This rule is being finalized following a public comment period and a thorough analysis of information and views from consumers, health care providers, academicians and industry. FDA is requiring that labeling of OTC vaginal contraceptive/spermicidal products containing N9 bear the following warnings:

Other information in the new labeling includes:

FDA is issuing the final rule to provide a clear, consistent message that N9 is not effective in preventing HIV transmission, and that N9 may actually facilitate transmission of the disease for those who are at risk for HIV/AIDS. This final rule is consistent with FDA’s draft guidance for N9 use with condoms.

The full text of the final rule is posted at http://www.fda.gov/OHRMS/DOCKETS/98fr/07-6111.htm

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration today approved Kuvan (sapropterin dihydrochloride), the first drug of its kind approved to slow the effects of a rare genetic disorder that causes mental retardation, smaller brain size, delayed speech and other neurological problems. Tetrahydrobiopterin (BH4)-responsive phenylketonuria or PKU disease occurs in one out of every 12,000 to 15,000 live births in the United States.

PKU is a genetic disorder in which the enzyme phenylalanine hydroxylase (PAH), which helps our bodies break down phenylalanine (Phe), an amino acid found in foods, does not function properly. The result is high levels of phenylalanine in the blood. High levels of Phe are toxic to the brain and can lead to mental retardation, behavioral abnormalities, seizures, an inability to focus and organize information, and other neurologic complications.

“This new drug therapy represents hope for patients and families dealing with this difficult disease,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. “Now, for the first time, there is a medical intervention to help patients and their families slow the devastating neurological effects of this disease.”

Kuvan was first granted orphan drug designation by the FDA in January 2004. A drug is eligible for orphan drug designation if it is intended to treat a disease or condition that affects less than 200,000 people in the United States. A drug is also eligible for orphan drug designation if it is intended to treat a disease of condition that affects more than 200,000 and there is no reasonable expectation that the cost of developing and making available a drug for the disease or condition will be recovered from sales of the drug.

In January, 2006 Kuvan was granted a fast track designation by FDA based on its potential to offer a significant advantage to patients over current treatment options. The Kuvan new drug application (NDA) also received a priority review by FDA.

Kuvan works by increasing PAH enzyme activity in PKU patients with some residual PAH enzyme function. This then leads to an increased breakdown (metabolism) of phenylalanine (Phe), resulting in lower levels of Phe in the blood.

Kuvan must be used in combination with a phenylalanine-restricted diet. A patient can override the effects of Kuvan by not following a Phe-restricted diet. Phenylalanine is present in foods that contain proteins such as meats, dairy and egg products.

Patients being treated with Kuvan must have their blood phenylalanine levels monitored frequently by their physicians or other health care professional to ensure their Phe levels are in the normal range. FDA also recommends patients work closely with a dietitian to manage their diets. In addition, the manufacturer will establish general disease registries for PKU to help FDA and physicians track how patients are doing on the medication around the world in order to monitor its safety, efficacy and any adverse events.
.
The safety and efficacy of Kuvan was demonstrated in four short-term (up to 30 weeks) clinical studies with 579 patients with the disease. The data from these studies supported the clinical effectiveness of Kuvan in the treatment of BH4-responsive PKU. The most common adverse events reported included headache, diarrhea, abdominal pain, upper respiratory tract infection and throat pain.

Kuvan was developed by BioMarin Pharmaceutical Inc. based in Novato, Calif. in partnership with Merck Serono, a division of Merck KGaA, Darmstadt, Germany.

FDA Investigation Leads to Prison Sentence for Woman Who Claimed to Cure Lou Gehrig's Disease

The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations today announced that a New Jersey woman has been sentenced to 33 months in prison for falsely claiming that she could cure amyotrophic lateral sclerosis (ALS), commonly called “Lou Gehrig’s Disease.”

Elizabeth Lerner, a.k.a. "Elizabeth Cooperman," 38, of Egg Harbor City, N.J., was sentenced on Dec. 12, 2007, in the U.S. District Court of New Jersey for defrauding two ALS patients and their families. She also was ordered to pay $35,390 in restitution to the victims of the scheme and a criminal fine of $7,500.

"The FDA's Office of Criminal Investigations aggressively pursues those that provide false hope to patients by making unproven medical claims to unsuspecting patients — many with serious or life-threatening conditions who are desperate for a medical cure," said Terry Vermillion, director of FDA's Office of Criminal Investigations.

Lerner and her co-conspirator Charlene C. DeMarco, 55, a former doctor of osteopathy in Egg Harbor City, were convicted in December 2006 of all charges contained in an 11-count federal indictment. The indictment included one count of conspiracy to commit mail and wire fraud, three counts of mail fraud, six counts of wire fraud, and one count of money laundering.

DeMarco was sentenced on September 2007 to 57 months in prison, ordered to pay $32,190 in restitution to victims of the scam, and to pay a criminal fine of $7,500.

Evidence showed that from October 2002 until November 2004, DeMarco and Lerner agreed to defraud ALS patients and their families by claiming they could treat ALS patients with stem cell therapy, even though they knew they could not. The defendants falsely told their patients and their families that DeMarco had previously received FDA approval to treat ALS.

Jurors heard testimony from 24 government witnesses and viewed hundreds of pieces of evidence regarding the defendants' scheme.

Prosecutors said that Lerner and DeMarco also attempted to defraud two patients and their families in Louisiana of more than $140,000 and successfully obtained more than $40,000 from the scheme. Witnesses described how Learner and DeMarco illegally laundered money they received and used the proceeds for personal expenses.

This case was prosecuted by the United States Attorney's Office for the District of New Jersey in Camden and was investigated by the FDA's Office of Criminal Investigations’ Metro Washington Field Office.

FDA Grants Tentative Approval to First Generic for Antiretroviral Viread

The U.S. Food and Drug Administration has issued a tentative approval for a generic version of Viread (tenofovir disoproxil fumarate), a drug for use in combination with other antiretroviral agents in the treatment of HIV. 

Tentative approval means that although existing patents and/or marketing exclusivity prevent the approval of the product in the United States at this time, the product meets all of FDA's manufacturing quality and clinical safety and efficacy requirements.

The action marks the first tentative approval for a nucleotide analog reverse transcriptase inhibitor (nRTI). The nRTIs block an enzyme called reverse transcriptase, which is important to HIV production.

“The fight to save lives with high-quality anti-retroviral treatment is of significant importance to FDA,” said Gary Buehler, director of FDA’s Office of Generic Drugs. “Our scientists have been working diligently to make safe and effective treatments for AIDS available as quickly as possible to combat this worldwide problem.”

Tenofovir disoproxil fumarate is the latest addition of an anti-retroviral product that can be considered for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR), a five-year, $15 billion effort to fight the HIV/AIDS pandemic — the largest commitment ever by a single nation toward an international health initiative.

All FDA reviews of applications received in association with the PEPFAR program are expedited.  FDA reviewed this application for generic tenofovir disoproxil fumarate tablets in less than six months.

The U.S. Department of Health and Human Services and its agencies, including FDA, are part of an interagency effort under PEPFAR to accomplish the President's goals of treating 2 million HIV-infected people, preventing 7 million new infections, and caring for 10 million people infected with and affected by HIV/AIDS, including orphans and vulnerable children.

As of Sept. 30, 2007, PEPFAR supported life-saving anti-retroviral treatment for a total of more than 1.3 million men, women and children in 15 focus countries in sub-Saharan Africa, Asia and the Caribbean. On May 30, 2007, President Bush announced that he would work with Congress to reauthorize PEPFAR for another five years.

The tenofovir disoproxil fumarate 300 milligram tablets are manufactured by Matrix Laboratories, LTD, of Andhra Pradesh, India.

For more information

PEPFAR on the Web
www.pepfar.gov
http://www.fda.gov/oia/pepfar.htm

FDA Generic Drugs
http://www.fda.gov/cder/consumerinfo/generic_equivalence.htm

Food and Drug Administration Press Releases

As part of the FDA’s comprehensive Food Protection Plan initiative, the agency today released self-assessment tools for industry to minimize the risk of intentional contamination of food and cosmetics. The tools are companion pieces designed to make previously issued industry guidance documents more user-friendly and practical.

Food protection is one of FDA’s top priorities and that means guarding against both intentional and unintentional contamination of foods. “The tools FDA is providing will help members of the food and cosmetic industry identify opportunities to better guard against intentional contamination of their products,” said CFSAN  Acting Center Director David Acheson.

In 2003, FDA issued a set of Food and Cosmetic Security Preventive Measures Guidance documents. These documents are aimed at operators of food and cosmetic establishments, as well as businesses that produce, process, store, repack, relabel, distribute, sell or transport foods, food ingredients, and cosmetics to help them minimize the risk of malicious, criminal, or terrorist actions involving products under their control.

The guidance documents are:

Using feedback from industry, the FDA repackaged the information found in the guidance documents and created a corresponding self-assessment tool for each document. By using the tools, industry members can get a quick and detailed assessment of the measures they currently have in place to protect against intentional contamination of their products. With this consolidated information, it will be easy for them to see where meaningful improvements to their current practices can be made.

The self-assessment tool asks the participant to mark the presence of a variety of food protection measures with a Y (Yes), N (No), N/A (Not Applicable), or Don't Know for each item. Examples of measures addressed by the self-assessment tools include the possibility of product tampering; identification of security procedures and responsibilities; and evaluation of response strategies in the event of product tampering or other intentional contamination.

For more information

The Food and Cosmetic Security Preventive Measures Guidance documents and self assessment tools http://www.cfsan.fda.gov/~dms/defguids.html

The Food Protection Plan
http://www.fda.gov/oc/initiatives/advance/food/plan.html.

FDA Issues Second Safety Warning on Fentanyl Skin Patch

The Food and Drug Administration today issued its second safety warning about the fentanyl transdermal system, an adhesive patch that delivers a potent pain medicine through the skin. In July 2005, the agency issued a similar warning to the public and to health care providers, saying that the directions on the product label and on the patient package insert should be followed exactly in order to avoid overdose. FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it.   

In addition, the agency is asking manufacturers of all fentanyl patches to update their product information and to develop a medication guide for patients.

The fentanyl skin patch contains the opioid fentanyl, a potent narcotic. The skin patch was approved by FDA in 1990 for use in patients with persistent, moderate-to-severe pain who have become opioid tolerant – meaning that they have been using another strong opioid narcotic pain medicine around-the-clock, and have been using the medicine regularly for a week or longer. The skin patch is most commonly prescribed for patients with cancer.

Recent reports to FDA describe deaths and life-threatening side effects after doctors and other health care professionals inappropriately prescribed the patch to relieve pain after surgery, for headaches, or for occasional or mild pain in patients who were not opioid tolerant. In other cases, patients used the patch incorrectly: The patients replaced it more frequently than directed in the instructions, applied more patches than prescribed, or applied heat to the patch – all resulting in dangerously high fentanyl levels in the blood.

“There is an unmet need to provide patients suffering from chronic pain with safe and effective products that will not only alleviate their pain, but that will also be tolerable when used chronically,” said Bob Rappaport, M.D., FDA’s director of the Division of Anesthesia, Analgesia and Rheumatology Products. "While these products fill an important need, improper use and misuse can be life-threatening. Therefore, it is crucial that doctors prescribe these products appropriately and that patients use them correctly."

In its Public Health Advisory and Health Care Professional Sheet published today, FDA stressed the following safety information:

This information will be reflected in the updated product information new medication guides for patients that manufacturers are being asked by FDA to develop.

The fentanyl skin patch is marketed under the brand name Duragesic by Johnson and Johnson, and generic versions of the product are sold by other manufacturers.

Food and Drug Administration Press Releases

This press release contains revisions posted Jan. 25, 2008.

The U.S. Food and Drug Administration today approved Voluven, an intravenous solution that prevents and treats a dangerous loss of blood volume, a condition that sometimes occurs during and after surgery.

Significant blood losses can cause a rapid drop in the volume of red blood cells and plasma circulating through the body. This can lead to shock, which is potentially fatal. Blood volume expanders are commonly administered to quickly restore some of the lost volume so that remaining red blood cells can continue to deliver needed oxygen to the body's tissues.

Voluven is manufactured from a water-insoluble starch modified to form hetastarch. Hetastarch-linked units (polymers) increase and maintain blood volume more effectively when used in combination with salt-and-water solutions.

"Massive blood loss is a life-threatening problem. Approval of Voluven provides clinicians with an alternative blood volume product that is safe and effective in a wide range of age groups," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.

In clinical trials, Voluven was compared to other approved blood volume expanders. During orthopedic surgery, Voluven was as safe and effective in expanding blood volume as Hetastarch, an approved starch solution.

In newborns and infants undergoing major surgery, Voluven was as safe and effective as an equivalent volume of another expander containing albumin, a protein found in the blood. In other trials conducted overseas, Voluven was as safe as other blood volume expanders used in those countries in patients ranging in age from less than two years to 75 years who were undergoing a variety of surgical procedures.

The most common side effect from Voluven was itching.

Voluven is not recommended for the following:

Voluven was not studied in patients with sepsis, an infection of the blood. A post-market clinical trial involving patients with sepsis is planned.

Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is manufactured by Fresenius Kabi, Bad Homburg, Germany.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) is advising consumers not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, also marketed as Shangai Chaojimengnan, products.

These products, which originate in China, are being marketed for the treatment of erectile dysfunction (ED) and for sexual enhancement. Although labeled as dietary supplements, these products do not qualify as dietary supplements because they contain undeclared active ingredients of FDA-approved prescription drugs for erectile dysfunction. The products are thus drugs that are illegal because they lack FDA approval.

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients can not be validated.

"Products like these put consumers at considerable risk because they contain undeclared active ingredients in FDA approved drugs that require a prescription to obtain," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research (CDER). "An unsuspecting consumer with underlying medical issues may buy and take these products without knowing that they can cause serious drug interactions."

FDA performed chemical testing of the products that revealed that Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, and Lady Shangai contain sildenafil, the active ingredient in Viagra, an FDA-approved drug for erectile dysfunction. Shangai Regular, also marketed as Shangai Chaojimengnan, contains an unapproved substance with a structure similar to sildenafil that may cause similar side effects and drug interactions. Neither sildenafil nor the analog of sildenafil is listed as an ingredient on the label of any of these products.

FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they feel are related to the use of these products. Consumers and health care professionals can report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm. FDA recommends that consumers should talk to their health care provider about FDA-approved treatments for erectile dysfunction. FDA may take further regulatory actions to protect consumers from these illegal products.

The products are packaged and distributed by Shangai Distributor, Inc. of Coamo, Puerto Rico.

The U.S. Food and Drug Administration (FDA) is warning consumers not to eat raw oysters harvested from West Karako Bay, a section of Growing Area 3 in Louisiana. These oysters, harvested from Dec. 3 through Dec. 21, may be contaminated with norovirus.

The U.S. Food and Drug Administration (FDA) is warning consumers not to eat raw oysters harvested from West Karako Bay, a section of Growing Area 3 in Louisiana. These oysters, harvested from Dec. 3 through Dec. 21, may be contaminated with norovirus.

Symptoms of norovirus infection include nausea, vomiting, diarrhea and stomach cramping. Affected individuals often experience low-grade fever, chills, headache, muscle aches, and a general sense of tiredness. Most people show symptoms within 48 hours of exposure to the virus, with the illness lasting one to two days. However, the illness can become serious for the very young, the elderly and people with weakened immune systems.

Consumers who ate raw oysters on or after Dec. 3 and experienced these symptoms are encouraged to contact their health care providers and local health departments. Consumers concerned about the origin of oysters they have recently purchased should contact the place of purchase to determine if the oysters were harvested from the identified area during the Dec. 3-21 period.

FDA has received reports of norovirus infection in seven individuals who ate raw oysters on Dec. 13 at a restaurant in Chattanooga, Tenn. The Tennessee Department of Health's test results from two of the ill patients were positive for norovirus. FDA confirmed the presence of norovirus in shell oysters harvested from the West Karako Bay section of Growing Area 3 and were served at the restaurant. Louisiana Department of Health and Hospitals closed the affected growing area on Dec. 21. FDA is working with the states involved to determine if any additional actions may be necessary to ensure public health protection.

The original shipper of the oysters is Prestige Oyster Company of Theriot, La. The company shipped the oysters to Bon Secour Fisheries in Bon Secour, Ala. Bon Secour Fisheries, in turn, shipped the oysters to the restaurant in Chattanooga. Considering the shelf-life of the product, it is possible that suspect oysters from the designated area are still available in other retail and food service settings.

Persons with weakened immune systems, including those affected by AIDS, and persons with chronic alcohol abuse, liver, stomach or blood disorders, cancer, diabetes or kidney disease should avoid raw oyster consumption altogether, regardless of where the oysters are harvested.

Cooking destroys the virus, eliminating the risk of illness for both healthy and immunocompromised individuals. FDA advises that it's always best to cook seafood thoroughly to minimize the risk of foodborne illness. Consumers can continue to enjoy oysters in many cooked preparations by following this advice:

At Restaurants and other Foodservice Establishments:

In the Shell:

To prepare oysters for eating, choose one of the following methods:

Shucked Oysters:

To prepare oysters for eating, choose one of the following methods:

For further information contact:

FDA Food Safety Hotline: 1-888-SAFEFOOD
FDA website: www.cfsan.fda.gov



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