After pleading guilty to illegally marketing and misbranding Botox for off-label, unapproved uses between 2000 and 2005, Allergan, the manufacturer of Botox, will pay $600 million in fines.
Investigators found that the drug was marketed to doctors as a treatment for headaches, pain, muscle disorders, and cerebral palsy in children, none of which are approved by the FDA.
“The FDA had approved therapeutic uses of Botox for only four rare conditions, yet Allergan made it a top corporate priority to maximize sales of far more lucrative off-label uses that were not approved by the FDA,” said Sally Yates, a U.S. attorney in Atlanta. “The sales team executed the plan, and the sales skyrocketed.”
Cuurently, BOTOX is approved to treat four medical conditions: Cervical dystonia (head tilting, neck pain, and neck muscle spasms), Blepharospasm (eyelid spasms), Strabismus (crossed eyes) and severe underarm sweating unresponsive to tropical treatments. However, it has been reported that there are ongoing recuitment for clinical trials to test Botox for a host of ailments, including Parkinson’s disease, spinal cord injuries, excessive perspiration, depression and something called “curvature of the penis” in countries such as India, Poland, Serbia and Turkey.