FDA requires boxed warning for all botulinum toxin products

May 14, 2009

Prompted by reports of serious adverse events, the FDA announced that safety label changes, including a boxed warning and a Risk Evaluation and Mitigation Strategy, are necessary for all botulinum toxin products.

Prompted by reports of serious adverse events, the FDA announced that safety label changes, including a boxed warning and a Risk Evaluation and Mitigation Strategy, are necessary for all botulinum toxin products.

The FDA said it took the action because of reports that the effects of the botulinum toxin may spread 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.

The FDA also took the action because of the potential for serious risks associated with the lack of interchangeability among the three licensed botulinum toxin products.

Botulinum toxin is not FDA-approved for any urologic indications, but it is used off-label for the treatment of overactive bladder and BPH.

"Updated labels for this class of products will help health care professionals and patients better understand the risks and benefits," said Russell Katz, MD, of the FDA. "Botulinum toxin products have benefits but can cause serious health problems, and it is important that anyone who administers or uses these products understands these risks."