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Public Citizen Wants Black-Box Botox Labels After 16 Deaths

Posted by Jane Akre
Thursday, January 24, 2008 11:24 PM EST
Category: Major Medical, Protecting Your Family
Tags: FDA and Prescription Drugs, Toxic Substances

 

Putlic Citizen has petitioned the FDA asking for a stronger warning on Botox

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As far as cosmetic procedures go, Botox advertising makes the procedure sound about as routine as getting a haircut.

But the citizen's group, Public Citizen is now sounding a warning that Botox can cause serious injury and death.

Tiny amounts of the botulinum toxin type A is used to deaden muscles and diminish wrinkles between the forehead.  It's also used off-label to stop sweating and address pain.  

Public Citizen did a safety analysis of Botox procedures from FDA records covering 1997 to 2006. Altogether there were 658 adverse effects from injections. Among those included potentially life-threatening pneumonia and fluid in the lungs and difficulty swallowing.  There were also 16 deaths. 

The data comes from drug manufacturers, so Public Citizen believes the numbers could be much higher. 

The watchdog group today petitioned the FDA to strengthen warning to doctors and patients about the risks of Botox. The group wants the FDA to send warning letters to doctors so they take seriously the safety risks and share those adverse effect potential with their patients.  And they want a “black box” warning on the label- the strongest possible safety warning.

In 2003, the FDA warned maker Allergan that its ads were minimizing the risks of the botulinum toxin.    

Today the Botox Web site has warnings posted and doctors say they already alert patients about possible adverse side effects.

Botox is only approved for injection between the eyebrows. Some doctors may be using it “off-label” elsewhere on the face.  Other patients have had extremely adverse reactions when practitioners make up their own botulism toxin to save money and make more profit. 

One couple was permanently disabled after their phony Botox injections.   

"These significantly improved warnings...could prevent more serious complications, including death," said Dr. Sidney Wolfe, head of Public Citizen's Health Research Group. According to Wolfe, "Nobody should be dying from injected botulinum toxin.

Allergan, maker of Botox made no comment on the petition today.

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4 Comments

Posted by N. Kasparian
Friday, January 25, 2008 1:07 AM EST

I have been using Botox for a number of years to modify serious problems in my forehead and face in general. I have been very satisfied.. I think this story is giving a bad name to a very good product. This is truly a very egregious type of reporting.

Anonymous User
Posted by G. Lucas
Friday, January 25, 2008 1:45 PM EST

This is unbelievable. I know many people who suffer from forms of dystonia who cannot function without Botox. Many have taken it for 15+ years without side effects. These scare tactics actually prevent people from getting the medication they need. I have received Botox for blepharospasm and Meige. Actually, my Meige symptoms..dysphagia and aspiration were present long before I took the
Botox. I looks like Public Citizen hasn't done their homework!

Anonymous User
Posted by twahsner
Monday, January 28, 2008 5:35 PM EST

My son is getting about 15 injections every 6 months for cerebral palsy he is only 7. I am concerned. I have faxed the FDA to get a list of adverse reations reported on children under 12.

Anonymous User
Posted by lily
Saturday, February 09, 2008 11:08 AM EST

i'm 13 almost 14 and i get botox in my underarms for hyperhidrosis. i'm very worried that this might be truw. although i think if it was that serious that there wouldnt be millions of people who use it.

Comments for this article are closed.

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