FDA approves new suicide warnings on epilepsy drugs

The US Food and Drug Administration has approved new warnings on all epilepsy drugs highlighting the increased risks of suicide and suicidal  behavior. The change comes after a review of data from 199 clinical  trials  that was conducted last year (Marketletter July 14, 2008).

A few months later the agency announced that all epilepsy drugs would be  affected (Marketletter December 22, 2008). The FDA required drugmakers  to submit for each product a Risk Evaluation and Mitigation Strategy,  including a Medication Guide information handout for patients and  caregivers.

The action covers all anti-epileptics - more than 20 products in total -  including those that treat other conditions. US health care major  Johnson & Johnson's Topamax (topiramate), which is also used to prevent  migraines, is the highest-earning product in the group.