U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 8 Feb 2008 06:16:17 -0600 (CST)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: February 8, 2008

The following new items were added to the CDRH web pages on February 7, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	FDA Clears for Market First Decellularized Heart Valve
	Medical Device Safety Article: Prevent life-threatening communication breakdowns
	Federal Register: Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 8 Feb 2008 12:06:29 -0600 (CST)
Subject: FDA Notifies Public of Adverse Reactions Linked to Botox Use

FDA Notifies Public of Adverse Reactions Linked to Botox Use
Fri, 8 Feb 2008 10:13:00 -0600

The U.S. Food and Drug Administration today notified the public 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.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 8 Feb 2008 11:36:33 -0600 (CST)
Subject: FDA MedWatch- Botox And Botox Cosmetic (Botulinum toxin Type A) And Myobloc (Botulinum toxin Type B)- Reports of Respiratory Compromise And Death

FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. See the FDA's "Early Communication about an Ongoing Safety Review" for Agency recommendations and additional information for healthcare professionals.

Read the complete 2008 MedWatch Safety Summary including a link to the FDA's Early Communication about an Ongoing Safety Review regarding this issue at:  http://www.fda.gov/medwatch/safety/2008/safety08.htm#botox

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