In the latest round of what has become nearly a year-long simmering feud, the American Epilepsy Association, ensconced at its four-day-long annual meeting in Seattle, issued a letter to the U.S. Food and Drug Administration urging the watchdog group to reconsider its recommendation that package insert warnings be included along with prescriptions for eleven different medications used to treat seizure disorders, bipolar disorder, and migraines.
As always with package insert warnings, doctors are concerned about the potential for patient noncompliance, which in the case of epilepsy can be fatal. And in this instance, the AEA is critical of the methodology the FDA used in determining that a very small increased risk of suicidal thoughts and behaviors may accompany the use of anti-seizure medications.
After reading the press release in a news feed this afternoon, I decided to look into this further, given that I have been mostly on and sometimes off one of the drugs on the list since May. It didn't take long for me to decide that the AEA, for more than one reason, appears to have a strong case.
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