Deaths Spark FDA Review of Botox Safety

'Off-label' use under scrutiny after fatalities, severe reactions
By Michael O'Connor,  Newser User
Posted Feb 8, 2008 5:05 PM CST
camera-icon View 3 more images

(Newser) – The FDA is investigating the safety of Botox and a competing medication after learning that the drug might have caused death and breathing problems in children being treated for cerebral palsy, Reuters reports. That's not an approved use for the cosmetic drug; docs administer it because it can block nerve impulses and relax spasmodic muscles. No adult deaths were reported, according to the Wall Street Journal.

The reactions reported to the FDA are consistent with botulism, which occurs when the toxin reaches body parts beyond the injection site. As manufacturer Allergan's stock tumbled today, one analyst told Bloomberg he believes regulators will merely require that Botox packaging list the dangers of unauthorized use. "This thing will probably blow over in four to six months," he added.