Pharmaceutical company Allergan Inc.,  has filed suit against the FDA, arguing that restrictions placed on the marketing of Botox for off-label use actually work against the best interest of patients and physicians.

While Botox is commonly used – and FDA approved – to treat wrinkles on the face and forehead, a wide range of other treatment applications have been successfully used.  Doctors have used Botox to treat hyperhidrosis, migraine headaches, and muscle spasms.

Last year, the FDA announced that Botox complications had been linked to off-label use, particularly in children treated for limb spasticity.  According to current U.S. law, doctors are permitted to administer medicine for whatever application they deem appropriate.  Doctors aren’t however, allowed to market medicine for any application they please.

The marketing restrictions on Botox have apparently hindered the pharmaceutical company’s ability to distribute safety information related to off-label use.  The lawsuit is intended to increase the physician’s ability to access safety information such as possible risks, benefits, dosing, patient selection, etc. and is in no way intended to increase sales of Botox.