FDA Safety Labeling Changes: April-June 2017

Safety Labeling Changes and Boxed Warning Highlights Approved by FDA

Teresa Rubio, PharmD

Disclosures

August 31, 2017

Editorial Collaboration

Medscape &

Vigabatrin (Sabril®)

For more on this Drug Safety Labeling Change, click here and here.

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.

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