FDA follows through on questionable antiseizure-drug warning requirement

I recently wrote about the discord between the American Epilepsy Association and the U.S. Food and Drug Administration concerning the latter’s homing in on a meta-analysis suggesting that the risk of suicide among people taking any of eleven different antiseizure medications rises from about 1 in 400 to about 1 in 230. Now, the FDA has announced that these drugs–prescribed to people with migraine headaches and bipolar disorder as well as epilepsy–will be required targ to carry a warning that their use increases risk of suicidal thoughts and behaviors.
Even if the methodology were trustworthy, which the AEA believes is distinctly not the case, the net effect of this move will almost certainly be in the direction of harming the target population, not making it safer. Noncompliance by people with seizure disorders and severe mood disturbances is not exactly like forgetting to take your Flintstones One-a-Day. If anyone can justify this action on the FDA’s behalf I’m open to hearing it, but it seems to me someone was either bored, paranoid, or in need of setting an example (and I figure it’s Door Number Three).

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