FDA Recalls & Alerts - News Digest for March 7, 2005

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FDA News Digest

March 7, 2005

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IN THIS WEEK'S ISSUE

 

-- Safety Information Updated for Cholesterol-Lowering Drug Crestor

-- Marketing of Multiple Sclerosis Drug Tysabri Suspended

-- British Lift Suspension of Flu Vaccine Manufacturer's License

-- FDA Assesses Report on Food High-Temperature Byproduct Acrylamide

-- Manufacturing Violations Prompt Seizure of Paxil CR and Avandamet

-- Lutter to Succeed Hubbard as Head of FDA Policy and Planning

-- Recalls/Market Withdrawals

-- Recent Speeches

-- Public Meetings

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Safety Information Updated for Cholesterol-Lowering Drug Crestor

 

FDA has released safety information on the cholesterol-lowering drug Crestor that aims to clarify its risks and benefits. Of concern is the risk of rhabdomyolysis, a rare disorder that can cause serious muscle damage in patients taking Crestor as well other cholesterol drugs in the "statin" class. Crestor's manufacturer also has revised the drug's labeling to indicate that doctors should consider prescribing lower starting doses of Crestor in Asian-American patients, who may be at increased risk of the muscle disorder.

-- Press release: http://www.fda.gov/bbs/topics/news/2005/NEW01159.html

-- Public health advisory: http://www.fda.gov/cder/drug/advisory/crestor_3_2005.htm

-- Patient information sheet for health professionals: http://www.fda.gov/cder/drug/infopage/rosuvastatin/default.htm

 

Marketing of Multiple Sclerosis Drug Tysabri Suspended

 

Based on two reported serious adverse events, including one death, associated with the multiple sclerosis drug Tysabri, the drug's manufacturer has voluntarily suspended its marketing and its use in clinical trials. FDA is working with the company to determine the relationship between the drug and the adverse events.

-- Press release: http://www.fda.gov/bbs/topics/news/2005/NEW01158.html

-- Public health advisory: http://www.fda.gov/cder/drug/advisory/natalizumab.htm

 

British Lift Suspension of Flu Vaccine Manufacturer's License

 

The British Medicines and Healthcare Products Regulatory Agency has lifted its October 2004 suspension of Chiron Corp.'s license to manufacture flu vaccine. FDA has been working closely with the British agency and says the action is an "important milestone" in Chiron's efforts to supply vaccine to the United States for next flu season.

http://www.fda.gov/bbs/topics/news/2005/NEW01160.html

 

FDA Assesses Report on Food High-Temperature Byproduct Acrylamide

 

FDA is reviewing a March 2 report by the Food and Agriculture Organization and the World Health Organization on acrylamide in food. Acrylamide is a natural byproduct of certain carbohydrate-rich foods when they've been fried, baked or roasted at high temperatures. It can cause cancer in lab animals at high doses, but researchers have not determined if a cancer risk exists in humans at the lower doses found in food. FDA plans to release new data this spring on acrylamide levels in the U.S. diet.

-- Press release: http://www.fda.gov/bbs/topics/news/2005/NEW01161.html

-- Acrylamide information: http://www.cfsan.fda.gov/~lrd/pestadd.html#acrylamide

 

Manufacturing Violations Prompt Seizure of Paxil CR and Avandamet

 

In response to ongoing problems with the manufacturing quality of Paxil CR and Avandamet tablets, FDA and the Justice Department have initiated seizures of certain lots of the drugs from manufacturer GlaxoSmithKline Inc. Paxil CR is approved to treat depression and panic disorder, and Avandamet is an approved treatment for Type II diabetes. FDA urges patients who take these two drugs to continue to take them but to talk to their doctor about possible alternatives for use until the manufacturing problems are resolved.

-- Press release: http://www.fda.gov/bbs/topics/news/2005/NEW01162.html

-- Questions and answers: http://www.fda.gov/oc/qanda/PaxilandAvandamet.html

 

Lutter to Succeed Hubbard as Head of FDA Policy and Planning

 

William Hubbard, who has served for 14 years as FDA's associate commissioner for policy and planning, is retiring from the agency. Among his many accomplishments at FDA, Hubbard was a principal designer of the nutrition label, which for the first time provided nutrition information on all food packages. Randall Lutter, Ph.D., who has been named to succeed Hubbard in the position, has worked at FDA since 2002 as a chief economist and has broad experience the economic and policy aspects of the agency's work.

http://www.fda.gov/bbs/topics/news/2005/NEW01163.html

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RECALLS/MARKET WITHDRAWALS

 

The following products are being recalled for the reasons shown. Go to the linked pages for more information.

 

 

Limited number of Medtronic Lifepak 500 Automated External Defibrillators (may fail to analyze patient's heart rhythm)

http://www.fda.gov/oc/po/firmrecalls/lifepak02_05.html

 

Peekay and Mayur Golden Raisins (undeclared sulfites)

http://www.fda.gov/oc/po/firmrecalls/Peekay03_05.html

 

Fresh Batch Candy Cookies (undeclared eggs)

http://www.fda.gov/oc/po/firmrecalls/parco02_05.html

 

Kamison Lucky Candy (undeclared peanuts)

http://www.fda.gov/oc/po/firmrecalls/gemini02_05.html

 

An Ching Sweet Ball (undeclared peanuts)

http://www.fda.gov/oc/po/firmrecalls/newchina02_05.html

 

Several Afrah Pastries products (various undeclared allergens, depending on product)

http://www.fda.gov/oc/po/firmrecalls/afrah02_05.html

 

 

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 60 days, go to

http://www.fda.gov/opacom/7alerts.html

 

To access the RSS feed of FDA recalls information, go to

http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml

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RECENT SPEECHES

 

FDA Acting Commissioner Lester M. Crawford, D.V.M., before the Generic Pharmaceutical Association; subject: regulation of generic drugs (Feb. 26)

http://www.fda.gov/oc/speeches/2005/GPhA0301.html

 

To view an archive of past speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm

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PUBLIC MEETINGS

 

 

March 11 -- FDA Antiviral Drugs Advisory Committee; under discussion: proposed treatment for hepatitis B (Gaithersburg, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cder12531d031105.html

 

March 15 -- FDA Vaccines and Related Biological Products Advisory Committee; under discussion: safety and immunogenicity of two tetanus diphtheria and pertussis vaccines (Bethesda, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cber12391d031505.html

 

March 17-18 -- FDA Blood Products Advisory Committee; under discussion: transmissible spongiform encephalopathies, West Nile virus, and FDA's Critical Path Initiative (Gaithersburg, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cber19516dd03171805.html

 

March 21-22 -- FDA/New Mexico University Food Labeling Public Workshop; intended to provide information about FDA food labeling regulations and other related subjects to regulated industry, especially small businesses and startups (Las Cruces, N.M.)

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-2450.htm

 

March 21 -- Public hearing on reporting adverse events to institutional review boards (Rockville, Md.)

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-2300.htm

 

March 23 -- FDA Nonprescription Drugs Advisory Committee; under discussion: processes used to demonstrate the effectiveness of antiseptic products in health care settings (Gaithersburg, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cder12541d032305.html

 

March 24 -- Joint meeting of the FDA Dermatologic and Ophthalmic Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; under discussion: evaluating the switch of topical corticosteroids from prescription to over-the-counter status (Gaithersburg, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cder12534d032405.html

 

April 5-6 -- Animal Feed Safety System: A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds; a forum for comments on a safety program designed to minimize public health hazards posed by animal feed products (Omaha, Neb.)

http://www.fda.gov/cvm/index/animalfeed/AFSSMtg/AFSSMtg042005.htm

 

April 5-6 -- FDA/University of Arkansas workshop on food labeling; intended to provide information about FDA food labeling regulations and related subjects to regulated industry, especially small businesses and startups (Fayetteville, Ark.)

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-2299.htm

 

April 27-28 -- 11th Annual FDA Science Forum; includes a free public session on personalizing your healthcare, and scientific sessions on nanotechnology, animal models, cancer diagnosis/treatment, risk management, and other topics (Washington, D.C.)

http://www.cfsan.fda.gov/~frf/forum05/sxsf05pr.html

 

For a list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html

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