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.]
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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.

? 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@oc.fda.gov.


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Possible Botulism Risk: New Era Expands Recall
Mon, 22 Dec 2008 15:06:00 -0600


New Era Canning Company, New Era, Mich., is expanding its product recall because of potential Clostridium botulinum contamination to all canned green beans and garbanzo beans distributed by the company nationwide over the last five years


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This is exactly why I don't eat vegetables. Too risky.

Botulism Risk from Canned Green Beans
Wed, 26 Dec 2007 12:15:00 -0600

FDA is warning consumers about potentially contaminated canned cut green beans manufactured by New Era Canning Company, New Era, Mich. New Era is voluntarily recalling the green beans because they may be contaminated with Clostridium botulinum (C. botulinum), the bacterium that causes botulism.

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Update your subscriptions, modify your password or 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@govdelivery.com.

Look for the "Printer-friendly PDF" link in the upper right corner of select articles; this feature makes it easy to distribute copies. Text of articles published on FDA's Consumer page may be republished without permission. Credit to "FDA Consumer Health Information" as the source is appreciated.


Visit FDA's Consumer page: http://www.fda.gov/consumer/

Send story ideas to: fdaconsumerlist@oc.fda.gov