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.