Epilepsy drugs may get new label

The Food and Drug Administration wants to add its most serious warning label to epilepsy drugs, based on evidence that they increase the risk of suicide in patients.

FDA scientists have proposed adding a “black box” warning about suicide risks to all drugs used to treat seizures.

An FDA analysis of nearly 200 studies showed that patients taking anti-seizure drugs were more likely to have suicidal thoughts and behaviors than those taking placebos. Although the reported problems were extremely rare, the FDA found that drug-treated patients faced about twice the risk. On average, those patients experienced suicidal thoughts or behavior 0.43% of the time, compared with 0.22% of those taking placebos.

Anti-seizure drugs are used for a variety of illnesses in addition to epilepsy, including migraines, certain nerve-pain disorders and psychiatric diseases such as bipolar disorder.