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The GABITRIL REMS consists of a Medication Guide to inform patients about the potential risks associated with the use of GABITRIL.
GABITRIL is indicated as an adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
In the case of Gabitril, which had been approved for use for epilepsy, Cephalon told the sales force to visit not just neurologists, but also psychiatrists, and to promote the drug for anxiety and other psychiatric indications.
The company currently markets three proprietary products in the United States: PROVIGIL, GABITRIL (tiagabine hydrochloride) and ACTIQ (oral transmucosal fentanyl citrate) (C-II) and more than 20 products internationally.
A new bolded warning is being added to labeling for Gabitril (tiagabine) to notify physicians of the risk of seizures in patients without epilepsy who are being treated with this drug, the Food and Drug Administration has announced.
Gabitril is approved as an adjunctive therapy for partial seizures in patients 12 years and older.
A new bolded warning is being added to labeling for Gabitril (tiagabine) to notify physicians about the risk of seizures in patients without epilepsy who are being treated with this drug, the U.