Apparently drugmakers' fears of new labeling for epilepsy drugs [1] were well founded. The agency says it's very close to a deal with the companies on the labeling changes. And FDA has posted its written review of the data on suicidal thoughts and behavior among patients using the meds. The upshot: Twice the risk of suicidal thoughts or behavior among patients using one of the meds versus those using placebo (0.43 percent versus 0.22 percent). And, the agency said, the risk was consistent across all 11 drugs it studied.
An FDA advisory panel will meet next month to mull over the data themselves. But sources told USA Today that the labeling could be changed even in advance of that meeting.
- read the report [2]
- check out the Pharmalot item [3]
Related Articles:
FDA may slap warning on epilepsy meds [1]
FDA: Epilepsy drugs boost suicial thoughts [4]
Top 10 Drug Warnings and Recalls of 2007 [5]
Links:
[1] http://www.fiercepharma.com/story/fda-may-slap-warning-epilepsy-meds/2008-06-04
[2] http://www.healthnews.com/disease-illness/suicide-warnings-way-epilepsy-drugs-1193.html
[3] http://www.pharmalot.com/2008/06/what-the-fda-says-about-epilepsy-meds-suicide/
[4] http://www.fiercepharma.com/story/fda-epilepsy-drugs-boost-suicide-risk/2008-02-01
[5] http://www.fiercepharma.com/special-reports/top-10-drug-warnings-and-recalls-2007