Botulinum toxin injections, best known for smoothing wrinkles, have been linked to cases of serious reactions, including death, the Food and Drug Administration announced Friday.The FDA has received at least one report of a patient hospitalized after getting injections for cosmetic purposes, but it was "unlikely" that the drug was to blame, Russell Katz, director of the neurology products division at the FDA's Center for Drug Evaluation and Research, told reporters.
Most of the severe reactions occurred in children treated for limb spasticity associated with cerebral palsy, an off-label use, Katz said. Such off-label uses are appropriate if the physician believes they are, Katz said.Diane Rehm, host of National Public Radio's The Diane Rehm Show, has used Botox — as an off-label treatment —for nearly 10 years to treat spasmodic dysphonia, a vocal disorder that previously robbed her of her voice. "If I had not been able to continue my career, that would have been one thing," Rehm said Sunday. "But I could not walk into a drugstore and say my own name to someone else so that they could understand me. Your voice is your life."
Although Rehm says she has never experienced any harmful side effects, she plans to ask her doctor about the FDA warning.The reactions announced by the FDA Friday resembled botulism, a rare but potentially deadly paralyzing illness caused by botulinum toxin in tainted food, the agency said in what it called "an early communication about an ongoing safety review" of Botox, Botox Cosmetic and Myobloc, the three brands sold in the USA.
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