FDA Warns of Children's Deaths Linked to Botox

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In 2002, the FDA approved the use of Botox to improve the appearance of moderate to severe frown lines between the eyebrows. Two years later, the agency signed off on Botox as a treatment for severe underarm sweating, known as "primary axillary hyperhidrosis." The drugs work by using botulinum toxin, which blocks nerve impulses to muscles, causing them to relax.

FDA officials said Friday that they weren't advising health-care professionals to stop prescribing these products. However, they are urging doctors and their patients to watch for signs of botulism poisoning.

The agency said it is reviewing the safety data from clinical trials submitted by the makers of the drugs. In addition, the FDA is looking at "post-marketing adverse event reports" and any published studies.

"We don't think the current labeling is as clear about the distant effects in children and in patients without underlying neuromuscular disorders," Katz said.

In a statement released Friday afternoon, Solstice Neurosciences Inc. said "safety of patients treated with Myobloc (botulinum toxin type B) Injectable Solution has always been of primary importance" for the company. "We support education and training of physicians in a number of ways regarding the proper use of this product as outlined in the prescribing information."

Public Citizen said the FDA should follow the lead of European drug regulators who have issued warnings about the dangers of using botulinum toxin.

"Nobody should be dying from injected botulinum toxin. Educating physicians and patients about what adverse symptoms to look for and when to seek immediate medical attention will save lives," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a prepared statement.

More information

For more on Botox, visit the FDA.