Pharmaceutical company Allergan Inc. – the manufacturer of Botox -  has filed a suit against the FDA, contending that marketing restrictions for Botox are actually inconsistent with the interests of patients and physicians.

While Botox is commonly used, as 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, muscle spasms, and many other problems.

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.   Last year, the FDA announced that Botox reactions had been linked to off-label use, particularly in children treated for limb spasticity.

The marketing restrictions placed on off-label Botox have evidently hindered Alelrgan’s ability to distribute safety information related to such uses.  The current 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 boost Botox sales.

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