Cephalon, Inc.announced that a Risk Evaluation and Mitigation Strategy (REMS) for its antiepileptic medication GABITRIL(R) (tiagabine hydrochloride) has been approved by the U.S. Food and Drug Administration (FDA). The GABITRIL REMS consists of a Medication Guide to inform patients about the potential risks associated with the use of GABITRIL. The implementation of the REMS is a result of FDA’s identification in 2008 of an increased risk of suicidal thoughts and behavior with the class of antiepileptic drugs (AEDs) which includes GABITRIL. The current product labeling already contains a warning that includes this risk. The addition of a Medication Guide for patients and ongoing assessment of the REMS program is consistent with the company’s commitment to safe and appropriate use of its medications.
The GABITRIL Medication Guide will be available on the product website, www.gabitril.com, and will be dispensed with every prescription. The three-pronged REMS assessment plan will be implemented on an ongoing basis to evaluate (1) patients’ understanding of the potential serious risks associated with the medication; (2) the distribution and dispensing of the Medication Guide; and (3) adherence to distribution and dispensing requirements as well as corrective actions taken to address noncompliance. In accordance with the approved REMS, the company is currently updating all labeling related to GABITRIL to include the Medication Guide.