FDA looking into Botox adverse events, including deathsFDA issued an “early communication” advising that it is looking into adverse reactions to Botox and Botox Cosmetic that have been blamed for hospitalizations and even deaths -- mostly in children treated for cerebral palsy-associated limb spasticity, an off-label usage.
The reactions, the agency said, are suggestive of botulism, indicating that the neurotoxin has spread beyond the injection site.
The review also applies to Solstice Neurosciences' Myobloc.
Last month, Public Citizen filed a petition with the agency urging that the products carry black box warnings. The group said a review of FDA data turned up 180 reports of life-threatening reactions to people in the US following injections, including 18 deaths – four of which involved patients under the age of 18.
Botox is approved for numerous cosmetic and therapeutic uses as a muscle relaxant. The agency approved the use of the neurotoxin to treat primary axillary hyperhidrosis, or severe underarm sweating, in July.