Safety

Sabril (Vigabatrin) Tablets

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

September 2015

Summary View

WARNINGS AND PRECAUTIONS

Magnetic Resonance Imaging (MRI) Abnormalities in Infants
  • … Neurotoxicity … and brain histopathological changes were observed in dogs exposed to vigabatrin during the juvenile period of development. ..
Neurotoxicity
  • … Administration of vigabatrin to juvenile dogs produced vacuolar changes in the brain gray mater (including the septal nuclei, hippocampus, hypothalamus, thalamus, cerebellum, and globus pallidus). Neurobehavioral effects of vigabatrin were not assessed in the juvenile dog…

USE IN SPECIAL POPULATIONS

Pediatric Use
  • …Oral administration of vigabatrin (5, 15, or 50 mg/kg) to young rats during the neonatal and juvenile periods of development (postnatal days 4-65) produced neurobehavioral (convulsions, neuromotor impairment, learning deficits) and neurohistopathological (brain gray matter vacuolation, decreased myelination, and retinal dysplasia) abnormalities. The no-effect dose for developmental neurotoxicity in juvenile rats (the lowest dose tested) was associated with plasma vigabatrin exposures (AUC) substantially less than those measured in pediatric patients at recommended doses. In dogs, oral administration of vigabatrin (30 or 100 mg/kg) during selected periods of juvenile development (postnatal days 22-112) produced neurohistopathological abnormalities (brain gray matter vacuolation). Neurobehavioral effects of vigabatrin were not assessed in the juvenile dog. A no-effect dose for neurohistopathology was not established in juvenile dogs; the lowest effect dose (30 mg/kg) was associated with plasma vigabatrin exposures lower than those measured in pediatric patients at recommended doses

 

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...

 

Page Last Updated: 10/09/2015
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