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Stock Falls After Bad Botox News

Posted by Jane Akre
Saturday, February 09, 2008 12:03 AM EST
Category: Major Medical, Protecting Your Family
Tags: Toxic Substance, FDA and Prescription Drugs, Wrongful Death, Medical Malpractice

FDA wants more information about Botox after  16 deaths are reported among children using the drug for spastic muscles.


Stock for the popular anti-wrinkle drug Botox took a plunge Friday after the FDA warned that some children given the drug have died.

Botox Cosmetic maker, Allergan’s shares dropped 5.6 percent Friday afternoon after news from the Food and Drug Administration that it would be looking further into the safety of the product it approved to minimize forehead wrinkles. 

The children who died had the brain injury cerebral palsy and were given Botox, also known as botulinum toxin, to treat spasticity in their legs.

Allergan says the quantity the children receive is far larger than generally given for facial wrinkles. The FDA says the reaction may be due to the overdose.

Botox is used off-label to treat a variety of muscle spasm conditions for which it is not approved.

The FDA also reports a woman given Botox Cosmetic treatments for forehead wrinkles was hospitalized.

No word from the federal agency how many adverse reports it is probing.

Symptoms of botulism include difficulty swallowing or breathing, muscle weakness or difficulty holding up you head.  The FDA says there is a potential for this to happen no matter why you are getting the drug.

Just two weeks ago the watchdog group, Public Citizen petitioned the agency to include a black box, the strongest warning, on the label of Botox Cosmetic by Allergan and competitor Myobloc by Solstice Neurosciences Inc.

It noted 180 reports of adverse effects including 16 deaths, difficulty swallowing or pneumonia. Public Citizen says the FDA knew about the risks of using botulinum toxic three years ago.

“The FDA must immediately force the drug makers to send out warning letters to doctors, similar to what drug regulatory agencies in Europe already require," said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, after the FDA's announcement on Friday.

The drug’s label already warns about the potential for the botulinum toxin to spread beyond the injection site in patients with neuromuscular disease.  The children killed didn’t suffer from a neuromuscular disease however, but a brain injury. 

The companies will be asked to provide additional safety data. Last year, Britain and Germany required the equivalent of a black box warning be sent to every doctor in those countries.  

Botox was approved in 2002 to lessen the appearance of lines between the eyebrows. In 2004 it was approved to treat underarm sweating.

FDA officials are stopping short of advising doctors to stop prescribing Botox, but are urging patients to watch for any signs of reaction. #



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