The ever-increasing popularity of BOTOX® treatments has not come without a serious price for drug manufacturer Allergan, Inc., as hundreds of millions of dollars in lawsuit settlements and penalties have ensued since the prescription’s FDA approval in 1989.
BOTOX® works by injecting a botulinum toxin into a muscle, which paralyzes it. When used cosmetically, the toxin “freezes” facial muscles and prevents wrinkling in the skin. BOTOX® is also commonly used off-label (not approved by the FDA) for headaches, muscle spasms and Cerebral Palsy in children. Sometimes, the botulinum toxin spreads beyond the site of injection and can lead to the contraction of Botulism, a serious and life-threatening illness.
Affected patients experience symptoms such as:
- Double vision
- Blurred vision
- Slurred speech
- Muscle weakness
- Difficulty swallowing
- Respiratory paralysis
- Loss of bladder control
Cosmetic use of BOTOX® continues to appear safe when used as directed. The harmful side effects listed above are largely a result of off-label use. In 2010, Allergan, Inc. admitted to using misleading marketing tactics which encouraged physicians to use BOTOX® off-label, and agreed to a $600 million settlement with the U.S. Department of Justice as a penalty for misbranding.
Multiple lawsuits against the makers of BOTOX® and the physicians who have administered the injections off-label have taken place since its introduction to the market. Victims to its side effects have been awarded millions of dollars due to physician negligence, medical battery and wrongful death. As of 2009, the FDA issued a black-box warning on BOTOX®, warning of the potential complications of toxin spread.
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