FDA Approves New Warnings For Epilepsy Drugs

WASHINGTON (Dow Jones)--The Food and Drug Administration on Tuesday said it approved new labels for epilepsy drugs that include warnings about an increased risk of suicidal thoughts and behaviors associated with the medicines.

The labeling for the epilepsy drugs, which include Johnson & Johnson's (JNJ) Topamax, GlaxoSmithKline PLC's (GSK) Lamictal and Novartis AG's (NVS) Tegretol and Trileptal, comes several months after the FDA ordered the drugs' labels be updated with warnings about suicidal risks with the medications.

In December, the FDA issued a public-health advisory about the drugs, saying a review of clinical studies showed there was one additional case of suicidal thoughts or behaviors for every 500 patients treated with an anti-epileptic drugs compared with a placebo, or fake pill.

The agency said it wanted the labels to be updated to include risk information about suicide. Since then, the FDA has worked with the companies to determine the appropriate labeling and on April 23 approved the new labels, according to a posting on the FDA's Web site Tuesday.

Patient groups have expressed concerns that the updated labeling would cause patients to stop getting treatment for epilepsy. These groups also said the labels didn't need to be updated because the risk of suicide associated with the drugs was extremely small.

The FDA said it is working with the companies to create medication guides that can be given to patients to explain the risks associated with the drugs, and what symptoms are associated with suicide and suicidal thoughts.

-By Jared A. Favole, Dow Jones Newswires; 202-862-9207; jared.favole@dowjones.com

Source

May 5, 2009