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  • FDA Date: 10/23/2017

    Vigabatrin REMS

    Goal of the Vigabatrin REMS Program

    The goal of the Vigabatrin REMS Program is to mitigate the risk of vision loss associated with vigabatrin by:

    • Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring.

    • Ensuring that vigabatrin is only dispensed to patients with documentation that patients are informed about the risk of vision loss associated with vigabatrin and the need for periodic visual monitoring.

    REMS Elements

    • Elements to Assure Safe Use

    • Implementation System