Patients treated with botulinum toxin type A (Botox and Botox Cosmetic) and botulinum toxin type B (Myobloc) for a variety of conditions have experienced adverse reactions, including respiratory failure and death, according to a February notice from the FDA.
The FDA is reviewing safety data from clinical trials of these products and postmarketing adverse event reports. The agency said there is no evidence of a defect in the product and that the reactions may be related to overdosing.
Kuehn BM. Botox Risks Under Review. JAMA. 2008;299(12):1417. doi:10.1001/jama.299.12.1417-d