July 11, 2008 -- A lawsuit filed Wednesday by a Texas law firm contending that the popular wrinkle remover Botox killed four people and injured 11 is drawing mixed reactions.
Attorneys representing the plaintiffs are calling for a halt to promotions of "off-label" use of the drug and are asking that physicians be better trained in the use of the drug.
Physicians who have administered Botox for years insist that cosmetic use is safe and that consumers who opt for off-label use should be sure the physician is well trained in treating the specific condition. In off-label use, a physician uses a drug to treat a condition for which it is not specifically approved but evidence suggests it will help.
The popular wrinkle remover is approved to treat blepharospasm (involuntary blinking of the eye), cervical dystonia (involuntary contractions of the neck muscles), hyperhidrosis (excess sweating), and strabismus (crossed eyes).
Botox Cosmetic is approved for treating moderate to severe facial frown lines. Myobloc, a similar drug, is approved for adults with severe neck muscle spasm.
The Botox Lawsuit: Details
In the lawsuit, lawyers representing the plaintiffs claim that Allergan, the maker of Botox, promotes "off label" use for treating patients with cerebral palsy and other conditions that have not been approved by the FDA. And, the lawsuit says, Allergan fails to warn Botox users properly of the possibility of fatal and life-threatening injuries from the injections.
The four deaths included two children and two adults, says Ray Chester, one of the attorneys bringing the lawsuit. "The two were children with cerebral palsy and they got very high doses to treat spasticity."
The two adult deaths included a 69-year-old woman who died in March after getting the drug to treat her shoulder and neck pain. A 60-year-old man died in April after getting the drug to treat excessive salivation, Chester says.
Only three of the 11 plaintiffs got the drug for cosmetic purposes, he says. The rest got the drug for other conditions. Among the complaints of the 11 with injuries are droopy eyelids, numbness, headaches, and swallowing and breathing problems.