A Botox lawsuit filed in the Superior Court of California on behalf of 15 people who allege that they suffered severe or fatal side effects from Botox treatments is scheduled to go to trial later this month against the manufacturer, Allergan, Inc.
Botox is approved for both cosmetic use to reduce the appearance of wrinkles in the skin and to treat medical conditions such as strabismus (crossed eyes), hyperhidrosis (excess sweating), cervical dystonia (involuntary contractions of the neck muscles) and blepharospasms (involuntary blinking of the eye). However, it also commonly used off-label, such as for treatment of stiff and jerky movements associated with cerebral palsy in children.
Extremely minute quantities of Botulinum Toxin A are contained in Botox, which is the bacteria associated with the muscle paralyzing condition Botulism.
The lawsuit over Botox was filed in July 2008, on behalf of plaintiffs who allege that the manufacturer illegally promoted the medication for non-approved uses and failed to adequately warn about the risk of severe and potentially life-threatening injuries associated with side effects of Botox.
The Botox trial is scheduled to begin on January 25 in Orange County, Calif., according to a report by AttorneyatLaw.com. Among plaintiffs in the case are the families of two young children who died after Botox injections to treat cerebral palsy.
The FDA warned about potential risks associated with Botox in February 2008, after a number of reports were received involving deaths, breathing problems and other adverse reactions associated with use of Botox. At that time, the FDA indicated that the adverse reactions were most commonly seen among children with cerebral palsy, where the typical dose of Botox injection used is substantially larger than what is normally prescribed for cosmetic purposes.
In August 2009, the FDA announced a new “black box” warning about the risk of Botox problems, including potentially life-threatening botulism-like side effects. The warning now alerts users that the toxin used in Botox and other some other products could spread from the area of the injection to other areas of the body. This could cause botulism symptoms, including life-threatening swallowing and breathing difficulties or death.