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FDA Issues Botox Warning

Complications and deaths noted, especially in children

By D. O. Volente
ConsumerAffairs.com

February 9, 2008

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This could get ugly.

The company that produces America's most popular quick-fix for facial wrinkles is now a target of the U.S. Food and Drug Administration (FDA). FDA announced late Friday it was conducting a safety review of Allergan Inc.'s Botox and a similar product, Myobloc, after receiving reports of deaths and breathing problems in some patients who were injected with Botox syringes.

According to the FDA, Botox is being injected at an alarming rate among children, especially those who are being treated for cerebral palsy-associated limb spasticity. Neither product is approved for such use in the U.S. and there have been deaths associated with the usage of the two treatments among children.

However, as bizarre it may sound, the FDA says there were no reports of deaths in adults, and some of the adverse reactions may have been related to an overdose of the products.

Russell Katz, director of the FDA's division of neurology products, said no deaths have been seen with cosmetic use of Botox as a wrinkle treatment, although there was one hospitalization in a patient who reported receiving a Botox injection for frown lines. Katz said it isn't clear if Botox played a role.

Katz said the agency didn't yet have a firm count on the number of deaths or serious side effects but said they were a "relative handful." He explained that the FDA is still reviewing its adverse-event reporting system and data submitted by Allergan and Solstice Neurosciences Inc., a private firm in Malvern, Pa., that makes Myobloc.

Caroline Van Hove, an Allergan spokeswoman, said the company supported FDA's safety review. She said Botox is approved in many countries outside the U.S. to treat limb spasticity in children with cerebral palsy and the typical dose of active ingredient in the injection is significantly larger than a dosage for cosmetic use. She said Allergan is aware that doctors use Botox in children with cerebral palsy but the company doesn't promote the product for such use.

In a statement, Solstice Neurosciences also said it supported the FDA's safety review and said it would provide the agency with any additional information needed.

Botox and Myobloc are designed to block nerve impulses to certain muscles, causing them to relax. Both products are approved to treat cervical dystonia, or uncontrolled muscle contractions of the neck and shoulder muscles. Botox is also approved for cosmetic use to treat wrinkles between the eyebrows and to help control excessive underarm sweating.

In some cases, the toxic, active ingredient in Botox and Myobloc can affect respiratory muscles and cause difficulty swallowing, a condition known as dysphagia. Both products warn doctors and consumers of that side effect.

The FDA's Katz said what is new is that it appears the active ingredient in Botox can spread from distant parts of the body -- such as children's leg muscles -- to muscles that affect breathing rather than being just a local event as previously believed.

Last month, the consumer group Public Citizen said it found 16 deaths reported with usage of Botox or Myobloc from November 1997 through 2006. The group filed a petition with the FDA seeking the agency's strictest black-box warning discussing difficulty swallowing, pneumonia as a result of food getting into the lungs and, in rare instances, death from pneumonia.

Katz said the current FDA review isn't related to Public Citizen's petition, but said the agency is reviewing the petition "and trying to see how this fits together."

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