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.
Botox Lawsuit: Allergan Responds
In response to the lawsuit filed in Orange County, Calif., Superior Court, Caroline Van Hove, a spokeswoman for Allergan, tells webMD she cannot comment on the particular plaintiffs at this time but cites the drug's long and "remarkable" safety record.
"The product was first approved nearly 20 years ago," Van Hove writes in an email to WebMD. "More than 18 million vials of Botox and Botox Cosmetic have been distributed over the past 19 years with more than 15 million treatment sessions performed around the world. In its entire 20-year history, serious events have been reported rarely with this product."
"Allergen does not promote Botox for off-label uses," she writes.
Tiny amounts of the toxin are used for cosmetic purposes and work by relaxing the muscles for a few months and improving the appearance of wrinkles.
Botox Lawsuit: Physicians Respond
Physicians contacted by WebMD declined to comment directly on the lawsuit, but did comment on Botox use.
Cosmetic use of Botox is generally safe, while therapeutic or non-cosmetic use "requires caution," says John Reinisch, MD, director of craniofacial and pediatric plastic surgery at Cedars-Sinai Medical Center, Los Angeles, who has administered the drug for many years to children and adults for therapeutic and cosmetic purposes.
"It is probably the most commonly used cosmetic product today," he says. "It is extremely effective and extremely safe."
That's not to say, he adds, that cosmetic use isn't sometimes accompanied by side effects, such as temporarily droopy eyelids.
Doses for cosmetic use are a fraction of those used for therapeutic uses such as neck pain, he tells WebMD. People considering Botox should seek out licensed practitioners who are skilled in using the drug for the specific purpose, he says.
Another physician, Alan Gold, MD, a plastic surgeon in Great Neck, N.Y., and president of the American Society for Aesthetic Plastic Surgery, agrees that cosmetic use is generally safe. "I think Botox over the last 20 years has had an incredible record of safety and efficacy, if used for cosmetic purposes in the ways prescribed."
Off-label use, he says, carries additional risk that consumers need to be aware of.
Botox: Government Concerns
The FDA announced in February its ongoing evaluation of reports of adverse reactions such as respiratory problems and death following the use of Botox and Myobloc for approved and unapproved uses. The review does not mean the FDA is advising physicians to discontinue use of the product or whether more regulatory action is needed, according to a statement on the FDA web site.