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The FDA announced on February 8, 2008, that it is investigating reports of systemic adverse reactions suggestive of botulism in patients, mostly children, treated with botulinum toxin type A (Botox and Botox Cosmetic) and type B (Myobloc).
The reactions reported include respiratory compromise; they occurred at a variety of doses and following treatment for various conditions. However, many of the most serious cases — involving hospitalization or death — occurred in children treated for cerebral palsy-associated limb spasticity. The FDA has not approved botulinum products to treat this condition.
While the investigation continues, the FDA advises clinicians to:
understand that clinical doses, expressed in units, are not comparable among the thr…