Bipolar And Anti Seizure Drugs
September 4th, 2008 Posted by: admin
A panel of independent experts that advises the US Food and Drug Administration (FDA)
is meeting this Thursday in Beltsville, Maryland, to review evidence of increased suicide risk for
patients on anti-seizure drugs, and is expected to agree to the FDA’s recommendation that these
drugs carry the highest level of warning, the so-called “Black Box” label.
The FDA’s meta-analysis concluded that:
“Drug-treated subjects had a statistically significant increase in risk of Suicidal Behavior or Ideation
compared to placebo-treated subjects for all antiepileptic drugs combined.”
The increased risk across all drugs examined came to an odds ratio of 1.80, which rounded up is nearly double.
As well as epilepsy, AEDs are used to treat a range of other conditions like migraines, certain types of nerve pain,
and psychiatric disorders like bipolar disorder.
bipolar disorder
So while there is no explanation of the biological mechanism that is producing this higher suicide risk,
the FDA’s view is that all AEDs should be regarded as having this increased risk, as Katz put it:
“In our estimation, there seems to be no compelling reason to: 1) ignore what appears to be a very clear
empirical finding of an increase in suicidality, despite no obvious explanation for this finding, or 2) not
generalize the conclusion to other AEDs. This is the Agency’s current view.”