Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B) (February 8, 2008)

FDA issued an early communication about ongoing safety review of Botox products due to reports of systemic adverse reactions including respiratory compromise and death. These reported reactions are suggestive of botulism, which occurs when botulinum toxins spread in the body beyond the site where it was injected. The most serious cases that resulted in hospitalization and death occurred mostly in children treated for cerebral palsy-associated limb spasticity, which is not an approved use in the United States.