Monday, July 14, 2008

Politics In The Suicide Black Box Decision For Bipolar, Epilepsy Meds

As some of you know, yesterday the FDA's psychopharmacology advisory committee declined to approve the FDA's recommendation that a black box warning be added to 11 anti-seizure drugs used to treat bipolar disorder and epilepsy. I've not seen a lot of press on the decision yet, so the committee's reasoning is not clear to me, but you can glean a bit from this early piece by the Dow Jones News Service:

"Panel members raised concerns about the unintended consequences of adding a black-box warnings to epilepsy [drugs], saying such a move would make doctors wary of prescribing the drugs.

"Panel member Sean Hennessy, a doctor, said he thinks there should be an additional warning on epilepsy drug labels, but added the FDA's analysis shows suicidal risks are 'modest.'

"'To me (the data) says there ought to be a warning, but given what we know about the effects on prescribing, I don't know if they rise to the level of a black box,' Hennessy said.

"GlaxoSmithKline Plc's (GSK) Jack Modell, vice president of clinical development, said his company believes additional warnings should be included on the label. An FDA analysis showed that Glaxo's epilepsy drug Lamictal had a higher increased risk of suicidal behavior and suicidal thoughts than other drugs."


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