Off-label Botox applications linked to deaths
-Grinza
08/17/2009 - Botox, the famous anti-wrinkle drug, has been linked to fatal and severe complications in cerebral palsy patients, a treatment unapproved by the U.S. Food and Drug Administration (FDA). Botox and other similar products use a purified form of botulinum toxin that temporarily paralyzes the muscles to stop repetitive movements, preventing wrinkles from forming. More>>>
FDA Signs Off On Botox Warning; Changes Generic Name
-The Wall Street Journal
08/04/2009 - The Food and Drug Administration said Monday it approved a new warning on Allergan Inc.'s (AGN) Botox and a similar product about the possibility of life-threatening breathing and swallowing problems, following up on an earlier announcement about tougher warnings. More>>>
Man Says Botox Left Him Crippled
-Courthouse News Service
07/24/2009 - Botox injections for writer's cramp left a man with devastating brain injuries, including "multiple ischemic brain lesions" and "dementing encephalopathy," he says in an $11 million claim against Allergan, which makes the drug. More>>>
Botox injection nearly kills woman - Cerebral Palsy treatment spread too far
-TheSpec
06/27/2009 - A Hamilton family is questioning Health Canada’s approval of Botox after their daughter became so ill she could have died within days of being given the drug to treat cerebral palsy. More>>>
Botox must have stronger warnings, American regulator says
-Telegraph U.K.
06/11/2009 - Botox – the cosmetic wrinkle eliminating injection favoured by celebrities – must have stronger warnings on its packaging after serious side effects, the American drugs regulator has said. More>>>
Cerebral Palsy Botox treatments have new warnings
-Examiner
05/14/2009 - The Food & Drug Administration has released a new warning for the off-label use of Botox in spastic pediatric Cerebral Palsy patients. This is an update to the 2008 Early Communication regarding the drug. This new information will be added to the product label and patient information for future production of Botox A & B. More>>>
US FDA Expresses Concern Over Safety of Botox-type Products: Botox-type drugs are attracting adverse notice from the US Food and Drugs Administration.
-MedIndia
05/05/2009 - A little after it approved Dysport, a rival to Botox, the agency said both drugs, along with a third called Myobloc, should carry black-box warnings to alert patients and doctors to serious safety risks. More>>>
Black Box Warning Required for All Botulinum Toxin Products by FDA
-Emaxhealth
05/04/2009 - The FDA has announced changes to the safety label on botulinum toxin due to reports that the effects of the toxin may spread from the area of injection to other areas of the body causing serious adverse problems. This new label requirement is required on Botox and Botox Cosmetic (botulinum toxin type A); Myobloc (botulinum toxin type B); and a new FDA-approved product, Dysport (abobotulinumtoxinA). More>>>
F.D.A. Orders Warning Label for Botox
-TheNewYorkTimes
05/02/2009 - Botox and other similar antiwrinkle drugs must now carry the most stringent kind of warning label, the Food and Drug Administration said Thursday. More>>>
Botox Must Warn of Muscle Weakness as U.S. Market Expands
-Bloomberg
05/02/2009 - Allergan Inc. was ordered by U.S. regulators to strengthen precautions on its wrinkle smoother Botox, hours after the first major competition to the treatment was approved for sale. More>>>
Allergan to Resolve Botox Safety Labels Article
-TheWallStreetJournal
05/02/2009 - NEW YORK -- Allergan Inc., which reported a 64% slump in first-quarter profit Friday, said it will work with the Food and Drug Administration to appropriately update labeling for its Botox and Botox cosmetic products. More>>>
If you or a loved one have been injured or suffered a loss due to Botox Side Effects you may be entitled to compensation. Contact the Botox Lawyers of Ennis & Ennis, P.A. today for a free Botox case evaluation by filling out the form on this page or calling toll-free: 1-800-856-6405.
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