FDA News
Digest
December 20,
2004
Note to Subscribers:
FDA News Digest is taking a holiday break the week of Dec. 27. We wish all our subscribers happy holidays, and we'll return to your e-mailbox Jan. 3.
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IN THIS WEEK'S
ISSUE
-- FDA Issues Advice on Celebrex
-- Study Shows Lung Cancer Drug Iressa Fails to Prolong Survival
-- Pesticide Residues Prompt U.S. Seizure
of Ginseng
-- FDA Approves Drug to Ease Complication
of Cancer Treatment
-- Drug OK'd to Help Eye Surgeons Remove
Advanced Cataracts
-- Recalls/Market
Withdrawals
-- Public Meetings
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FDA Issues Advice on Celebrex
FDA has provided advice to patients and physicians about the arthritis drug Celebrex after the National Cancer Institute reported an increased risk of adverse cardiovascular effects in a clinical trial of the drug. However, a similar ongoing study has not shown an increased cardiovascular risk, so FDA is examining all available data to determine if any regulatory action is needed. At this time, FDA urges doctors who determine that the drug is appropriate to prescribe the lowest effective dose. http://www.fda.gov/bbs/topics/news/2004/new01144.html
Study Shows Lung Cancer Drug Iressa Fails to Prolong Survival
Based on a post-approval study of patients taking Iressa (gefitinib), a treatment for non-small cell lung cancer, the drug's manufacturer has reported that the drug did not improve survival time when compared to patients taking a placebo. FDA urges patients taking Iressa to consult with their doctor as soon as possible. The agency emphasizes that two other treatments, Taxotere (docetaxel) and Tarceva (erlotinib), have been shown to prolong survival.
http://www.fda.gov/bbs/topics/news/2004/new01145.html
New Labeling Warns of Possible Liver Injury Linked to ADHD Drug
Labeling for Strattera, a treatment for attention deficit hyperactivity disorder in adults and children, is being updated with a new warning about the potential for severe liver injury. More than 2 million patients have used Strattera since it was first marketed in 2002.
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01335.html
Drug Approved to Treat
Age-Related Macular Degeneration
FDA has approved Macugen (pegaptanib), a therapy that slows vision loss in people with the "wet" (neovascular) form of age-related macular degeneration (AMD). A disease of the retina that causes severe and irreversible vision loss, AMD is a major cause of blindness in people over age 55. About 10 percent of those with AMD have the "wet" form.
http://www.fda.gov/bbs/topics/news/2004/new01146.html
Pesticide Residues Prompt U.S. Seizure of Ginseng
At FDA's request, U.S.
marshals have seized imported ginseng held for sale at FCC Products Inc. The company's bulk and blended ginseng
products were adulterated with unsafe pesticide residues. Due to the
uncertainty of the ginseng's distribution, FDA is issuing a nationwide warning
to those who may have used this product.
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01334.html
FDA Approves Drug
to Ease Complication of Cancer Treatment
FDA has approved Kepivance
(palifermin), an intravenous biological drug, to treat mucositis, a condition of
painful mouth sores experienced by some cancer patients undergoing radiation
treatments and chemotherapy in preparation for bone marrow transplants. The drug
helps reduce the chance that mucositis will develop, and it shortens the
duration when the condition does
occur.
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01332.html
Drug OK'd to Help Eye Surgeons Remove Advanced Cataracts
FDA has approved Vision Blue (trypan blue ophthalmic solution), a drug to aid eye surgeons in removing white cataracts, a very advanced form of clouding in the eye's lens. The drug can help reduce some of the risks of cataract surgery by allowing doctors to see the lens capsule better during cataract removal.
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01333.html
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RECALLS/MARKET
WITHDRAWALS
The
following product is being recalled for the reason shown. Go to the linked
page for more information.
Trader Joe's Pork Gyoza (product may contain shrimp, which could cause allergic reactions in some people)
http://www.fda.gov/oc/po/firmrecalls/traderjoe12_04.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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PUBLIC
MEETINGS
Jan. 12-13 --
Industry Exchange
Workshop on FDA Clinical Trial Requirements (San
Francisco)
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-26092.htm
Jan. 13-14 --
Joint
Meeting of the Nonprescription Drugs and the Endocrinologic and Metabolic Drugs
Advisory Committees; under discussion: proposal for over-the-counter sales of
the cholesterol-lowering drug Mevacor (Bethesda, Md.)
http://www.fda.gov/oc/advisory/accalendar/2005/cder12536dd01131405.htm
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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