Children with Cerebral Palsy Die After Botox Treatment

February 11, 2008 07:53 AM
by findingDulcinea Staff
Sixteen children have died and 180 suffered severe complications following the use of Botox to alleviate muscle spasms. The FDA investigates.

30-Second Summary

The Food and Drug Administration has issued a warning about the potential dangers of using the drug Botox and its competitor Myobloc in the treatment of cerebral palsy.

The 16 children who died numbered among a group of 180 treated with the drug who suffered symptoms similar to those associated with botulism, a type of food poisoning. Botulism is caused by the same bacterial toxin used to made Botox and Myobloc.

The toxin relaxes muscles by inhibiting the release of the chemical acetylcholine. Doctors have injected it into patients to treat muscle spasms, crossed eyes and uncontrolled blinking. It is most well known, however, as a cosmetic treatment for reducing wrinkles.

The toxin can be deadly when ingested, which most commonly occurs because of improperly canned food. Symptoms of botulism poisoning include slurred speech, blurred vision and difficulty swallowing. Botulism is fatal in 5 percent of cases, and recovery can take years.

Shares Allergan, the producer of Botox, said in an official statement on its Web site, “The BOTOX(R) labels specifically warn that patients with pre-existing neuromuscular disorders may be at increased risk of clinically significant systemic effects from typical doses of BOTOX(R).” Carolyn van Hove, a spokesperson for the company, told the Associated Press that the dosage given to cerebral palsy patients far exceeds that used in cosmetic treatments.

Russell Katz, the director of the FDA’s division of neurology products, says that these cases raise the possibility that Botox injections could spread to affect the muscles other than those being treated. That risk is under FDA investigation.

Headline Link: ‘FDA: Children Treated with Botox Died’

Background: Botulinum as a drug and as a toxin

Reactions: Allergan responds

Opinion & Analysis: ‘Botox Faces FDA Review’

Reference: The FDA’s safety review of Botox


Most Recent Beyond The Headlines