
Vigabatrin REMS Program
The U.S. Food and Drug Administration (FDA) has approved a single shared system Risk Evaluation and Mitigation Strategy (REMS) for all vigabatrin products called the Vigabatrin REMS Program. It is required by the FDA to ensure informed risk-benefit decisions before initiating treatment and to ensure appropriate use of vigabatrin while patients are treated.
Healthcare providers must be certified in the Vigabatrin REMS Program to prescribe VIGADRONE®, and patients must be enrolled in the Vigabatrin REMS Program to receive VIGADRONE®. All certified prescribers and enrolled patients in the SABRIL® REMS Program have been transitioned to the Vigabatrin REMS Program and do not need to recertify or re-enroll.