MedWatch - The FDA Safety Information and Adverse Event Reporting
Program

FDA and Cephalon, Inc. notified healthcare professionals and the public
that a Bolded Warning has been added to the labeling for Gabitril
(tiagabine) to warn prescribers of the risk of seizures in patients
without epilepsy being treated with Gabitril. FDA has received 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 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.

Read the complete 2005 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