FDA News
Digest
March 7,
2005
_______________________________________________________
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
_______________________________________________________
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
_______________________________________________________
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)
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
_______________________________________________________
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
_______________________________________________________
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
_______________________________________________________
Thanks for subscribing
to FDA News Digest. Our next posting will be
March 14.
To subscribe to or
unsubscribe from this list, go to
http://list.nih.gov/cgi-bin/wa?SUBED1=fda-newsdigest-l&A=1
