Medication Monitor

Generic Name (Trade Name—Company)
January 25, 2019


First Sabril generic approved to treat seizures in children, adults with epilepsy

FDA approved vigabatrin 500-mg tablets, the first generic of Sabril tablets, as an adjunctive therapy for treatment of complex partial seizures in patients aged 10 years and older who have responded inadequately to several alternative treatments.

Labeling for vigabatrin tablets includes a boxed warning for permanent vision loss. The generic vigabatrin tablets are part of a single shared-system Risk Evaluation and Mitigation Strategy program with other drug products containing vigabatrin to ensure safe use of the product.

The drug’s most common adverse effects include dizziness, fatigue, sleepiness, involuntary eye movement, tremor, blurred vision, memory impairment, weight gain, joint pain, upper respiratory tract infection, aggression, double vision, abnormal coordination, and a confused state.

Serious adverse effects include permanent vision loss and risk of suicidal thoughts or actions.

See the prescribing information for dosage and administration.