Botox manufacturer Allergan Inc has filed suit against the United States FDA, contending that marketing restrictions placed on off-label Botox are not beneficial for physicians or patients.
Although Botox is typically used (and approved) to treat wrinkles on the face and forehead, other treatment applications (approved and non-approved) are wide-ranging. According to current U.S. law, physicians are permitted to administer medicine for any application they deem appropriate. They aren’t however, allowed to market medicine for any use they please.
According to Allergan representatives, the lawsuit is not intended to increase sales of Botox, but rather increase the physician’s ability to access information regarding the safety (risks, benefits, dosing, patient selection) of off-label Botox use.
Some of the most common Botox treatments aside from wrinkle reduction are for hyperhidrosis, muscle spasms around the eye, and cervical dystonia.
