FDA News
Digest
November 29,
2004
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IN THIS WEEK'S ISSUE
-- FDA Strengthens Risk Management Program
for Acne Drug Accutane
-- Novel Type of Treatment Approved for
Multiple Sclerosis Patients
-- FDA Cracks Down on Texas Company Selling
Banned Ephedra
-- Recalls/Market
Withdrawals
-- Public Meetings
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FDA Strengthens Risk Management
Program for Acne Drug Accutane
To further reduce the risk of birth
defects associated with fetal exposure to the acne drug Accutane (isotretinoin)
and its generic equivalents, FDA is taking steps to strengthen the drug's risk
management program. The goal of the measures -- tentatively set to go into
effect July 2005 -- is to ensure that no woman starts taking the drug if she is
pregnant and that no woman on the therapy becomes
pregnant.
-- Press release: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01328.html
-- More information: http://www.fda.gov/cder/drug/infopage/accutane/accutane-qa20041123.htm
Novel Type of Treatment Approved for
Multiple Sclerosis Patients
FDA has licensed Tysabri
(natalizumab), a new kind of treatment for patients with relapsing forms of
multiple sclerosis (MS), an often disabling disease of the brain and spinal cord
that affects about 350,000 in this country. Tysabri is the first monoclonal
antibody treatment for MS, created by bioengineering part of a mouse antibody to
closely resemble that of a human antibody.
http://www.fda.gov/bbs/topics/news/2004/NEW01141.html
FDA Cracks Down on Texas Company
Selling Banned Ephedra
As part of FDA's continuing efforts
to keep off the market dietary supplements containing the banned substance
ephedra, U.S. marshals have seized more than 2.1 million capsules of the
ephedra-containing supplement Vitera-XT from Houston-based Asia MedLabs Inc. FDA
continues to warn consumers to avoid products containing ephedra because they
pose the risk of serious, possibly fatal, side effects.
http://www.fda.gov/bbs/topics/news/2004/NEW01140.html
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RECALLS/MARKET
WITHDRAWALS
No recall press
releases were issued in the past week.
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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PUBLIC
MEETINGS
Dec. 2 -- Advisory Committee for Reproductive
Health Drugs; under discussion: pending application for a testosterone patch for
surgically menopausal women (Gaithersburg, Md.)
http://www.fda.gov/oc/advisory/accalendar/2004/cder12537d120204.html
For a list of upcoming
FDA meetings, seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html
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