FDA approves REMS for Gabitril

The FDA has approved a Risk Evaluation and Mitigation Strategy (REMS) for the antiepileptic drug (AED) Gabitril (tiagabine hydrochloride, from Cephalon). 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 the FDA’s identification in 2008 of an increased risk of suicidal thoughts and behavior with the class of AEDs which includes Gabitril. The current Gabitril labeling already contains a warning that includes this risk.

The three-pronged REMS assessment plan will be implemented on an ongoing basis to evaluate patients’ understanding of the potential serious risks associated with the medication; the distribution and dispensing of the Medication Guide; and adherence to distribution and dispensing requirements as well as corrective actions taken to address noncompliance.

Gabitril is indicated as an adjunctive therapy in patients ≥12 years in the treatment of partial seizures.

For more information call (800) 896-5855 or visit www.gabitril.com.