Double the Risk of Suicide Not Enough to Warrant Black Box Warning
July 12, 2008 by MedHeadlines
Filed under Drugs, Epilepsy, FDA
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
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