About the Project

Bipolar Mood Disorders and Anti-Epileptic Drugs

On May 13, 2004, Attorneys General settled consumer protection claims regarding alleged deceptive “off-label” marketing practices of Warner-Lambert (now owned by Pfizer). This settlement focused on the states’ allegations that Warner-Lambert marketed Neurontin for various “off-label” indications. Neurontin is a prescription medication approved by the Food and Drug Administration (FDA) only for secondary treatment of epilepsy and for treatment of pain associated with shingles.

According to the terms of the agreement Warner-Lambert agreed to pay for programs that provide prescribers and/or consumers with fair and balanced information about drugs. The Executive Committee of the Neurontin Working Group, made up of eight states, was created by the settlement to allocate a portion of the settlement money for a corrective educational campaign to provide fair and balanced information to prescribers about Neurontin and other anti-epileptic drugs (AEDs).

The State of Vermont Office of the Attorney General issued a Request for Proposals in January 2005 for assistance in disseminating to appropriate audiences the evidence-based drug review, Anti-Epileptic Drugs for Mood Disorders and Pain. Researchers at the University of North Carolina at Chapel Hill (UNC) responded to the Request for Proposals and were awarded funding to develop the corrective educational campaign. The scope of this educational campaign focuses only on the use of AEDs for mood disorders

An evidence-based drug review, Anti-Epileptic Drugs for Mood Disorders and Pain, comparing the effectiveness and adverse event profiles of AEDs in treatment of bipolar mood disorder, neuropathic pain and fibromyalgia was commissioned independently from the Executive Committee by a number of state Medicaid agencies and other organizations. UNC researchers and physicians reviewed the commissioned report to ensure the accuracy of messages concerning the use of anti-epileptic drugs (AEDs), particularly Neurontin, to treat mood disorders.

The Anti-Epileptic Drugs for Mood Disorders and Pain report and the resulting key concepts and key messages are the basis for the messages and tools on this website, the print resources available, and a continuing medical education module.