FDA News -- FDA News Digest for February 11, 2008

FDA News Digest

February 11, 2008

_____________________________________

IN THIS WEEK'S ISSUE

» News

-- Generic Versions of Osteoporosis Treatment Fosamax Approved

-- First 'Decellularized' Heart Valve May Lower Immune Response Risk

-- FDA Acts to Stop Marketing of Unapproved Injectable Colchicine

» Safety Alerts/Recalls

» Upcoming Public Meetings

» Consumer Health Information

__________________________________________

NEWS

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.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01791.html

To view an archive of recent FDA news releases, go to

http://www.fda.gov/opacom/hpnews.html.

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.]

_____________________________________________

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.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01797.html

Medical Device Recall:

› Icy Hot Heat Therapy products

Reason for recall: reports by consumers of burns

http://www.fda.gov/oc/po/firmrecalls/chattem02_08.html

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.]

__________________________________________________________________

UPCOMING PUBLIC MEETINGS

For a complete list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

CONSUMER HEALTH INFORMATION

Each week in FDA News Digest, we spotlight consumer health information by offering links to timely articles about FDA activities and products the agency regulates.

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

If you would like to sign up to receive all consumer updates, go to

http://www.fda.gov/consumer/consumerenews.html

Questions or comments about our consumer stories? Send an e-mail to fdaconsumerlist@xxxxxxxxxx.

Thanks for subscribing to FDA News Digest.

Our next issue will be sent February 19.

Comments about FDA News Digest?

Send an e-mail to fdanewsdigest@xxxxxxxxxv.

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420