The FDA is close to adding a black box warning to epilepsy drugs after a safety review showed that they increase patients’ risk of suicidal thoughts and behavior. Rather than impacting sales of such drugs for the treatment of epilepsy, the warning will represent a greater threat to sales of these drugs for indications where alternative drug classes are available.
The FDA has analyzed data from 199 placebo-controlled trials of 11 epilepsy drugs involving a total of 43,892 patients. The results of the analysis showed that 0.43% of patients taking the drugs committed suicide, or thought about doing so, compared with 0.24% of patients taking a placebo. Continue reading “FDA Close to Adding a Black Box Warning to Epilepsy Drugs” »

