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FDA Warns of Children's Deaths Linked to Botox
Date:2/8/2008

in the lower limbs, which is an off-label use."

Katz declined to give the number of deaths or adverse events associated with the products.

However, the FDA's Adverse Event database for Botox and Myobloc found 180 adverse events in the United States, including 16 deaths, and four of these deaths occurred in children under 18, according to a petition filed last month by Public Citizen's Health Research Group. The petition asked the FDA to place a black box warning -- the strictest warning -- on these products.

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 issu
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