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Permanent link  Maker of Botox, Allergan, fined $600 million for marketing off label uses of the drug


Pharmaceutical giant Allergan has recently pleaded guilty and agreed to pay a $600 million to settle charges that it aggressively promoted off-label uses of the drug Botox that were not approved by the FDA, reports Off-label uses included treatment of headache, pain and cerebral palsy in children.

Most of the settlement is in criminal fines. However, Allergan will pay $225 million to a civil settlement agreement with both federal and state governments that such aggressive marketing resulted in federal and state insurance programs Medicaid, Medicare and Tricare reimbursing false medical claims.

As for how this affects dentistry, according to, use of Botox for dental procedures like retraining muscles after orthodontic treatment and treatment of disorders like bruxism and TMJ has surged in the US and UK in recent years. However, Allergan may only promote Botox to health care providers for limited medical procedures and treatment of lines between the eyes.


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I have always been leary about the off-label use of Botox in dentistry. I have seen CE course for Botox in dentistry and am concerned about the training these 8 hr course really provide.

Posted by: Dr. J.B. Miller ( on 05/16/2011