ParfumGigi@aol.com

7 mars, 2005 23:01 

-- 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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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

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 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

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

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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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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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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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.)

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