FDA News Digest
February 11, 2008
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IN THIS WEEK'S ISSUE
» News
-- Generic Versions of Osteoporosis Treatment Fosamax Approved
» Consumer Health Information
Generic Versions of Osteoporosis Treatment Fosamax Approved FDA has approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis, a condition that causes thinning and weakening of bones. Teva Pharmaceuticals USA was approved to manufacture alendronate sodium tablets in three once-daily dosing strengths (5 milligrams, 10 milligrams, and 40 milligrams) and two once-weekly strengths (35 milligrams and 70 milligrams). Barr Laboratories, Inc., was approved to manufacture a 70-milligram, once-weekly, dose of the drug.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01793.html First 'Decellularized' Heart Valve May Lower Immune Response Risk
FDA has cleared for marketing the first replacement heart valve from donated human tissue in which the cells have been removed. The CryoValve SynerGraft Pulmonary Valve and Valved-Conduit Allograft (SynerGraft) undergoes a process that "decellularizes," or removes the tissue's cells and cellular debris. What remains is a scaffold of connective tissue that still functions like a human heart valve, potentially lowering the risk of immune response and subsequent tissue rejection.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01794.html
FDA Acts to Stop Marketing of Unapproved Injectable Colchicine FDA plans to take enforcement action against companies marketing unapproved injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death.
To access the RSS feed of FDA news releases, go to http://www.fda.gov/bbs/topics/news/rssPress.xml. [What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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SAFETY ALERTS/RECALLS
Safety Alerts:
› FDA has issued a notice that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses. The agency has said the reactions may be related to overdosing and emphasizes that there is no evidence that these reactions are related to any defect in the products. The adverse effects were found in FDA-approved and in nonapproved usages of the products. The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, and they mimic symptoms of botulism, which may include difficulty swallowing, weakness, and breathing problems.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01796.html
› FDA has announced that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive large and fast ("bolus") doses of the drug. Serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock. Four people have died after receiving heparin, although the relationship to the drug is unclear. Medical Device Recall:
› Icy Hot Heat Therapy products
Reason for recall: reports by consumers of burns
For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the past 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
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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UPCOMING PUBLIC MEETINGS
For a complete list of FDA meetings, seminars, and other public events, go to
Here's what's in the spotlight this week:
› FDA 101: Product Recalls
From First Alert to Effectiveness Checks
http://www.fda.gov/consumer/updates/recalls123107.html
› Vital Facts About HIV Home Test Kits
http://www.fda.gov/consumer/updates/hivtestkit012908.html
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