Botox Maker Sues FDA, Wants to Tell Doctors More About Unapproved Uses

It’s not every day that a drug company wants to tell consumers more about a product. We are more likely to hear about pharmaceutical companies hiding information about side effects from users and federal regulators.

But Allergan, the Orange County, Ca.-based maker of the blockbuster cosmetic drug Botox, has filed a lawsuit against the Food and Drug Administration seeking the right to give doctors more information about therapeutic (non-cosmetic) uses of the product which have not been approved by the FDA.

According to a report today in the Orange County Register, Allergan went to court asking for permission to provide “accurate and complete” information about off-label uses of Botox to doctors. While drug companies cannot legally market products for uses that have not been approved by the FDA, physicians are free to prescribe and use products for unapproved uses as they see fit. Allergan says about 20 percent of all Botox use is for off-label treatments, according to the Associated Press.

The FDA recently ordered Allergan to tell doctors about the risks of off-label uses of Botox, but the company said in its lawsuit that in order to do so, it needs to present a complete view of the risks and benefits of using Botox for procedures that have not been given FDA approval, the Register reports.

Botox Off-Label Uses Increase

Botox, a purified form of botulism that temporarily paralyzes muscle movements, is approved as a cosmetic product to reduce the appearance of facial wrinkles. It also is FDA-approved to stop eyelid spasms, excessive underarm sweating, migraines, and problems with vocal cords and the bladder.

But many physicians also use Botox for off-label treatments without FDA approval, including halting muscle spasticity in people with cerebral palsy. In some cases, children and others with cerebral palsy who are injected with large amounts of Botox have died when the paralyzing effects of the drug moved through their bodies and reached the muscles responsible for breathing, swallowing, and other vital bodily functions.

Other off-label uses of Botox include treating chewing problems, swallowing problems, pelvic muscle spasms, drooling, hair loss, anal fissures, and pain from missing limbs, according to the Register report.

The drug racked up sales of $1.3 billion in 2008, Allergan said.

The FDA had no comment on Allergan’s lawsuit, the Register said.

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