US Pharm. 2008;33(3):84.

The FDA announced 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. The agency said that these reactions might be due to overdosing, and that there is no evidence that these reactions are related to defects in the products.

The adverse effects were found in both FDA-approved and nonapproved usages, although the most serious reactions were seen in children treated for limb spasticity resulting from cerebral palsy, which is not an FDA-approved use. The adverse reactions may include difficulty swallowing, weakness, and breathing problems. Following a review of data from clinical studies and postmarketing adverse event reports, the FDA will communicate its findings, recommendations, and any regulatory actions.

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