Feb 18, 2005 -- Today the Food and Drug Administration announced that a Bolded Warning will be added to the labeling for Gabitril (tiagabine) to warn prescribers of the risk of seizures in patients without epilepsy being treated with this drug. Gabitril has been approved since 1997 for patients 12 years of age and older as adjunctive therapy (used in addition to other medications) for partial seizures. Recently, the Agency has become aware of reports of the occurrence of seizures in more than 30 patients prescribed Gabitril for conditions other than epilepsy. Most of these uses were in patients with psychiatric illnesses. Such so-called off label prescribing is a common practice among physicians. Because of the risk of seizures, however, in addition to adding the Bolded Warning to product labeling, the sponsor has agreed to undertake an educational campaign targeted to healthcare professionals and patients in which such off label use will be discouraged.
>Fully Story: FDA Public Health Advisory
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