For full prescribing information for Sabril®, click here.
Updated Boxed Warning
WARNING: PERMANENT VISION LOSS
Because of the risk of permanent vision loss, SABRIL is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Vigabatrin REMS Program. Further information is available at www.vigabatrinREMS.com or 1-866-244-8175.
Public Information from the FDA and Medscape
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Cite this: FDA Safety Labeling Changes: April-June 2017 - Medscape - Aug 31, 2017.