Apparently it's a lawsuit kind of a day in pharma news. More than a dozen Botox users and their families sued Allergan yesterday, claiming that the company failed to warn them of its potentially dangerous side effects. The suit links the wrinkle-fighter--also used to treat severe muscle pain and spasms--to three deaths, including a 69-year-old nurse in Texas and a 7-year-old girl with cerebral palsy. The third death, of a 71-year-old woman this week, happened after she got Botox injections for wrinkles around her mouth. The suit also alleges that Botox treatments--for approved and off-label uses--disabled 12 other plaintiffs by giving them blurred vision, difficulty breathing, numbness, muscle weakness, and other injuries.
Reponding to the suit in the Los Angeles Times, an Allergan spokeswoman emphasized the drug's "remarkable safety record" over 20 years of use. The drug is often administered to patients with debilitating neurological conditions who are already at increased risk from their underlying diseases, the spokeswoman said.
The suit comes a few months after the FDA said it was reviewing reports of serious Botox side effects, including one death. (The review also covers Botox competitor Myobloc.) At the time, the agency said it was unaware of any deaths among those who used Botox for cosmetics uses; non-cosmetic uses tend to require higher doses. Meanwhile, in January, the consumer activist group Public Citizen announced it had linked 16 deaths to Botox or Myobloc from 1997 to 2006, and 180 life-threatening conditions over the same time period.
- see the Los Angeles Times story
- check out the law firms's release