In This Article
Subscribe to Health Updates
Children with Cerebral Palsy Die After Botox Treatment
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.
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’
The FDA issued a warning on Feb. 8 about the potential dangers of drugs based on the botulism toxin, including Botox and its competitor Myobloc. The FDA does not endorse the use of Botox to treat cerebral palsy.
Source: The Associated Press
Background: Botulinum as a drug and as a toxin
Botulinum is used as a medication for crossed eyes, uncontrolled blinking, muscle spasms and to eliminate the appearance of wrinkles. It works by blocking muscles’ release of a chemical called acetylcholine. Effects of the drug wear off after a few weeks.
Source: WebMD
Botulism is an illness characterized by a paralysis that starts with the cranial nerves and radiates down the body. It is caused by the botulinum toxin, most commonly found in improperly canned goods. Infant botulism is caused by the ingestion of substances, most commonly sweeteners such as honey or corn syrup, which a baby’s digestive tract cannot yet properly break down. This results in Botulinum being released in the intestine. Symptoms include muscle weakness, dry mouth, drooping eyelids, blurred vision, difficulty swallowing and slurred speech. Botulism has a 5 percent fatality rate, and recovery can take years.
Source: Centers for Disease Control and Prevention
Reactions: Allergan responds
A statement on Allergan’s Web site reports, “The product labeling for BOTOX(R) notes rare select cases of fatal outcomes in which some patients had significant debilitating conditions or may have had a history of cardiovascular disease or other co-morbid conditions. 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).”
Source: Allergan’s Web site
Opinion & Analysis: ‘Botox Faces FDA Review’
According to Russell Katz, director of the FDA’s division of neurology products, there have been no deaths related to the use of Botox to treat wrinkles. But the problems that have arisen in the treatment of cerebral palsy show that it might be possible for the active ingredient in Botox to spread to muscles besides the one it is intended to affect.
Source: The Wall Street Journal
Watchdog group Public Citizen covers the cerebral palsy Botox case, saying that the FDA’s warning “is not enough. The FDA should compel the drug makers to send warnings to doctors who use the injections and require doctors to give patients a written warning and description of the potentially life-threatening symptoms.”
Source: Public Citizen
Reference: The FDA’s safety review of Botox
The FDA’s official statement on its investigation into the Botox-related deaths is available on its Web site.
Source: FDA
Most Recent Beyond The Headlines
© 2012 Dulcinea Media, Inc.
