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U.S. Department of Health and Human Services

Safety

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Sabril (Vigabatrin) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

October 2013

Summary View

ADVERSE REACTIONS

Post Marketing Experience
  • Skin and Subcutaneous Tissue Disorders: Angioedema, maculo-papular rash, pruritus, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN).

 

December 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Monitoring of Vision
  • Monitoring of vision by an ophthalmic professional with expertise in visual field interpretation and the ability to perform dilated indirect ophthalmoscopy of the retina is required, unless a patient is formally exempted from periodic ophthalmologic assessment as documented in the Support, Help And Resources for Epilepsy (SHARE) program...