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Prompted by reports of serious adverse events, the U.S. Food and Drug Administration is requiring safety label changes, including a boxed warning and a Risk Evaluation and Mitigation Strategy, on all botulinum toxin products.

The agency took the action because of reports of the botulinum toxin spreading from the area of injection to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision, and drooping eyelids, according to a news release from the FDA.

These symptoms have mostly been reported in children with cerebral palsy being treated with the products for muscle spasticity, an unapproved use of the drugs. Symptoms also have been reported in adults treated both for approved and unapproved uses.

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