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Drug & Device News

By ALM Staff | Law Journal Newsletters |
December 26, 2006

More Cases Link Meningococcal Vaccine and Guillain Barr' Syndrome

On Oct. 20, the FDA and the Centers for Disease Control and Prevention (CDC) updated a previous alert to consumers and health care providers regarding reports of Guillain Barr' Syndrome (GBS) following administration of Meningococcal Con-jugate Vaccine A, C, Y, and W135 (trade name Menactra'), manufactured by sanofi pasteur. In addition to the five cases the FDA reported in October 2005, the new alert announced that 12 more such cases have developed. Fifteen of the 17 cases reported to date involved children 11-19 years old, and all these subjects developed GBS within six weeks of vaccination.

GBS is a rare neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in leg, arm and other muscles that can be severe and require hospitalization. It usually resolves on its own but some people may have residual neurological problems.

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