FDA Reviews Botox Risks

The Wall Street Journal reports the Food and Drug Administration said Friday that Botox and a similar drug, Myobloc, may be linked with rare side effects that could cause hospitalization or death.

According to the San Francisco Chronicle, most of the severe side effects of the drug occurred in children being treated for limb spasticity, a condition associated with cerebral palsy. These drugs are not FDA approved for this purpose in children or adults. However, it is used as an off-label; when a physician uses a drug approved for one disease to treat a different disease.

When asked about the risks for patients who use Botox for cosmetic purposes, Russell Katz, director of the Division of Neurology Products at FDA's Center for Drug Evaluation and Research said, "Given the number of cases we have in hand, we think it's probably quite rare given the number of reports we have and the apparently very large [cosmetic] use."

Botox and Myobloc are both forms of toxins made from bacteria that can paralyze muscles and cause botulism. However, in small doses they are used to relieve muscle spasms. Botox Cosmetic is approved by the FDA to reduce the appearance of wrinkles, reports the Chronicle.

Allergen Inc., which manufactures Botox, estimates $1.4 billion of Botox sales in 2008.