FDA Decides Not to Black Box Epilepsy (and Bipolar) Meds

11 07 2008

The FDA reviewed 199 studies on the effects of many drugs used to combat epilepsy (what most were designed for) and now used as frontline treatments for bipolar disorder, among others. While the study found that users of these drugs were about twice as likely to have suicidal thoughts versus those on placebos, I have to question the inclusion of bipolar folks in the study. How do you monitor a group who has suicidal thoughts prior to medication? (This has clearly been a problems with teens and SSRIs.) Especially when many have to try a number of drugs and cocktails before achieving some kind of stability? In the process of waiting for these drugs to work (what was the duration of most of the studies conducted?) were side effects bad enough to encourage suicidal ideation? How do these groups stack up against each other in terms of basic percentages? Are 50% of Depakote users epileptic? My gut reaction is that the number is lower. Just food for thought as the FDA probably made the right call, but the media oversimplified a complicated analysis.


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2 responses

3 08 2008
Intaccalp

Thank you

16 08 2008
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