The US Food and Drug Administration (FDA) has approved the first generic version of the antiseizure medication Sabril (vigabatrin,manufactured by Lundbeck).
Generic vigabatrin (500-mg tablets), is indicated as add-on therapy for the treatment of complex partial seizures in patients aged 10 years and older whose condition is refractory to several other treatments. Complex partial seizures, also called focal seizures, are a common type of seizure that typically last from 30 to 90 seconds and are often followed by a period of disorientation, confusion, and/or fatigue, the FDA noted in the release.
The most common side effects associated with vigabatrin tablets include dizziness, fatigue, sleepiness, involuntary eye movement, tremor, blurred vision, memory impairment, weight gain, arthralgia, upper respiratory tract infection, aggression, double vision, abnormal coordination, and a confused state. Serious side effects associated with vigabatrin tablets include permanent vision loss and risk for suicidal thoughts or actions.
Labeling for vigabatrin tablets includes a boxed warning for permanent vision loss.
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