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FDA issues public health advisory for Gabitril

Pharmacy Regulation Resource, February 23, 2005

The FDA and Cephalon, Inc., notified healthcare professionals and the public on February 22 that a bolded warning was added to the labeling for Gabitril (tiagabine), cautioning prescribers about the risk of seizures in patients without epilepsy who take the medication.

The FDA has received reports of the occurrence of seizures in more than 30 patients prescribed Gabitril for conditions other than epilepsy, otherwise known as an off-label prescription, according to an administration statement. Most of these uses were in patients with psychiatric illnesses, the FDA said.

Such off-label prescribing is a common practice among physicians. In addition to adding the bolded warning to labels, Cephalon agreed to undertake an educational campaign targeting healthcare professionals and patients and discouraging the off-label use of Gabitril because of the increased risk of seizures.

Read the complete 2005 FDA MedWatch Safety Summary, including links to the Public Health Advisory, Drug Information Page, Dear Healthcare Professional letter, and revised label at www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Gabitril.

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