Understanding the REMS program

It’s here for a reason.

REMS stands for Risk Evalution and Mitigation Strategy. It’s a drug safety program designed to reinforce medication use behaviors and actions that support the safe use of certain medicines, like VIGADRONE®, to help ensure the benefits of the medication outweigh its risks.

REMS programs are focused on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions that reduce the frequency and/or severity of the event.



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.


Vigabatrin REMS Forms

Prescribers who are not certified or who need to enroll a patient in the Vigabatrin REMS Program should visit the website for instructions and FDA-mandated forms.

Phone: 1-866-244-8175, Fax: 1-866-205-3072