FDA to review Botox after death

The FDA said it had reports of at least one death among patients who received a botulinum-based drug and what one official described as a “a relative handful” of serious side effects in which the toxin spread beyond the injection site.

The most serious of the reported problems occurred in children who had cerebral palsy and who were treated for arm and leg spasms with doses many times those used for cosmetic treatments — and in some cases at levels higher than recommended guidelines. The agency did not identify which drugs were involved in any of the problems.

Still, the development raised eyebrows among at least some of the millions of people who have made Botox a huge beauty treatment.

“Any time Botox is in the news, they become concerned and call,” said Jessica Wu, an aesthetic dermatologist in Los Angeles who has given and taken Botox injections since 1996. “I personally have had no patients who have had serious side effects.”

Las Vegas plastic surgeon Tracy Hankins said he too was bracing for calls from patients. But, he said, the FDA advisory contained no information that would “change my recommendation to patients or my personal use.”

Some regular Botox users said they wouldn’t give a second thought to going in for their next injection.

“I get so many compliments,” said a West Los Angeles woman who gets a Botox treatment three or four times a year. “I don’t want to stop.”

The FDA said that no product defect had been identified and suggested that the problems might have been related to overdosing.

Russell Katz, director of the FDA’s division of neurology drugs, told reporters in a conference call that the agency’s focus was on those larger doses, where the risk appears higher than in the quantities used to smooth facial wrinkles. “We don’t rule out the possibility that it may happen with cosmetic use,” he said.