Double the Risk of Suicide Not Enough to Warrant Black Box Warning

In January, the US Food and Drug Administration (FDA) began the process of evaluating 199 studies of anti-seizure drugs commonly prescribed for epilepsy and other disorders due to reports of suicidal behaviors in patients taking them.  Their findings led them to request a black-box warning be placed on the prescription labels of all 11 drugs under evaluation because the risk of suicide doubled when taking these drugs.  The findings of the FDA evaluation were presented for discussion to a 20-member panel of advisers who voted unanimously on Thursday to deny the request for the black-box warning. Read more

FDA Seeks Strongest Label Warning for Epilepsy Drugs

The US Food and Drug Administration (FDA) has announced plans to ask that a black-box warning be required of epilepsy drug labels due to an apparent increase in suicidal thoughts and behaviors associated with some of these drugs. A black-box warning on a drug’s label is the strongest warning against adverse side effects allowed of the pharmaceutical industry. Read more