FDA looking into Botox adverse events, including deaths

Share this article:
FDA 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. 
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Channel

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...