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Botox

Botox use linked to serious side effects

I want to share a report that I read on USA today about possible botox side effects.

Botulinum toxin injections, best known for smoothing wrinkles, have been linked to cases of serious reactions, including death, the Food and Drug Administration announced Friday.
The FDA has received at least one report of a patient hospitalized after getting injections for cosmetic purposes, but it was 'unlikely' that the drug was to blame, Russell Katz, director of the neurology products division at the FDA's Center for Drug Evaluation and Research, told reporters.
Most of the severe reactions occurred in children treated for limb spasticity associated with cerebral palsy, an off-label use, Katz said. Such off-label uses are appropriate if the physician believes they are, Katz said.
Diane Rehm, host of National Public Radio's The Diane Rehm Show, has used Botox — as an off-label treatment —for nearly 10 years to treat spasmodic dysphonia, a vocal disorder that previously robbed her of her voice. 'If I had not been able to continue my career, that would have been one thing,' Rehm said Sunday. 'But I could not walk into a drugstore and say my own name to someone else so that they could understand me. Your voice is your life.'
Although Rehm says she has never experienced any harmful side effects, she plans to ask her doctor about the FDA warning.
The reactions announced by the FDA Friday resembled botulism, a rare but potentially deadly paralyzing illness caused by botulinum toxin in tainted food, the agency said in what it called 'an early communication about an ongoing safety review' of Botox, Botox Cosmetic and Myobloc, the three brands sold in the USA.
The products' labeling already warns of the 'rare potential' for serious problems — such as difficulty swallowing and breathing — far from the site of the injection in patients with neuromuscular disorders. The label also describes the possibility of adverse side effects near the injection site, such as drooping eyelids after injections for frown lines.
But, Katz said, 'we believe we now have reports for distant side effects … in patients without underlying neuromuscular disorders,' including the children with spasticity, which generally is not considered a neuromuscular disorder. The FDA has received reports of fewer than 100 cases of adverse reactions linked to the injections, Katz said, adding that 'different people have different numbers.'
Public Citizen, a consumer advocacy group, petitioned the agency two weeks ago to strengthen warnings on the products' labels because of serious adverse reactions. Katz said the FDA already had been looking into the problem when it received the petition.
'Our analysis of FDA data found that between Nov. 1, 1997, and Dec. 31, 2006, the makers of the drugs had reported 180 U.S. cases of people developing serious conditions after receiving injections,' Sidney Wolfe, director of the Public Citizen Health Research, said in a statement Friday. Those 180 cases included 16 deaths, four of which occurred in children, Wolfe said.
In a statement responding to Public Citizen's petition, Sef Kurstjens, chief medical officer at Botox maker Allergan, said, 'in its entire history, there has never been a single reported death where a causal link to Botox Cosmetic was established.'

PS:Beauty comes from within
Regards
Dr.Beek
 
  Alexthink on 2008-02-11
This is just a forum. Assume posts are not from medical professionals.
Yes botox has many side effects.
 
dr mehmood last decade

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