A year ago the FDA required Allergan to add a black box warning Botox and a Risk Evaluation and Mitigation Strategy (REMS) to it’s safety labels for all botulinum toxin products. The agency took the action because of two main reasons.
In February, I wrote about the lawsuit in Orange County, California by a mother who alleges that the Botox treatments used to decrease muscle spasms weakened her daughters respiratory muscles, therefore causing her death.
Kristen Spears’ mother has sued Allergan alleging that her daughter died from a fatal reaction to the Botox treatments Kristen received for treatment for cerebral palsy. In March, Orange County Registar ran this article by Colin Stewart: Allergan wins Botox death trial.
Yesterday Katherine Hobson, WSJ Blog, wrote an article: Allergan Now Batting .500 in Botox Lawsuits
Yesterday an Oklahoma jury awarded $15 million to a woman who claimed she experienced pain and other problems after receiving the shots, reports the Orange County Register. (The O.C. is Allergan’s home base.) Though the jury ruled for Allergan on a product liability claim, it found the company was negligent in its off-label promotion of the drug, plaintiff’s attorney Ray Chester tells the Health Blog.
The Orange County Register article by Colin Stewart: Jury blames Botox
An Oklahoma jury Tuesday reached a $15 million negligent-damage verdict against the maker of Botox in the case of a 47-year-old woman who suffered years of pain after getting the wrinkle-smoothing injections.
The suit was filed against Irvine-based Allergan by Dr. Sharla Helton, an obstetrician and gynecologist in Oklahoma who fell ill and eventually lost her job after getting the injections in 2006.
She blamed Botox for double vision, breathing difficulty and years of continual pains in her arms, hands and feet.
The article states “wrinkle-smoothing injections” were done, doesn’t specifically tell us why Dr Helton had Botox injections, but leaves us to assume it was facial expression lines. Botox can be used safely, but should be done by a trained physician. I would not recommend the DIY trend.
Excess Sweating (April 20, 2009)
BOTOX -- Black Box Warning (May 7, 2009)
Neurotoxins: Dysport and Botox (January 6, 2010)
Black Market Botox (January 27, 2010)
Botox Gets Bad Press (February 10, 2010)
Botox for Upper Extremity Spasticity 9March 17, 2010)