Warning on Using Gabitril in Patients W/O Epilepsy May 2005

FDA is requiring that a new Bolded Warning be added to the labeling for Gabitril (tiagabine) an antiepileptic drug that's approved as adjunctive therapy in treating partial seizures. The warning is being issued because of reports that Gabitril has been associated with seizures in more than 30 patients who received it for conditions other than epilepsy.

Although Gabitril is approved only for treating epilepsy, it's been used off-label for treating other conditions, mainly psychiatric illnesses and chronic pain, and it's those uses where the seizures have occurred.

This could pose a confusing situation for practitioners: a drug that's used to control seizures in patients with epilepsy that could be causing seizures in other patients. In fact, an FDA Advisory notes that in some cases, prescribers have actually increased the dose of Gabitril when their patients without epilepsy started having seizures. Presumably they weren't aware that it was the Gabitril that might be causing the seizures, and they may have thought that since the drug is an anti-epileptic, it might control the seizures in these other patients.

Gabitril's manufacturer is changing the labeling to reflect this risk, and they've also agreed to undertake an educational campaign for both physicians and patients, making people aware of the risks and discouraging off-label use.

The FDA Advisory reminds practitioners that Gabitril has not been approved for conditions other than epilepsy, and that using it for these conditions constitutes an off-label use. The Advisory says that if a practitioner does decide to use the drug off-label, the risk of seizures should be explained to the patient.

Category:

Science & Technology

Tags:

• Warning
• Gabitril
• Patients
• Without
• Epilepsy
• FDA
• Seizures
• Patient
• Safety
• Off-Label