Nearly 200 clinical trials by FDA in 2008 had assessed the efficacy of many drugs including 11 anti-seizure medications. It was found that
‘Evidence for FDAs (U.S. Food and Drug Administrations) suicide-risk warning on anti-seizure medications may be lacking and may not apply to many anti-seizure drugs. This emphasizes that the risk of uncontrolled epilepsy and seizures may be greater when patients stop their drugs out of fear.
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Thus the statement was concluded as all the anti-seizure medications (that were approved since 2008) increase suicide risk. This affected the treatment choice for patients even with new anti-seizure drugs.
Lack of Evidence
However, subsequent analyses did not fit with the earlier results. Several trials of anti-seizure drugs assessed the suicidality risk but have also excluded people with histories of suicidal ideation. This makes it difficult to extrapolate to patient treatment.
To bring clarity to present-era drugs, the study researchers reviewed a total of 17randomized, placebo-controlled phase II and III clinical trials of the five new anti-seizures medications involving nearly 6000 patients – eslicarbazepine, perampanel, brivaracetam, cannabidiol (epidiolex), and cenobamate.
All these drugs are approved by the FDA since 2008. No evidence for increased risk of suicidal thinking or behavior was found in any of the five drugs. The suicidal thinking or behavior occurred in 12 of the 4000 actively-treated patients in the trial (0.3%) and seven out of nearly 2000 placebo-treated patients (0.35%).
“Our findings indicate the nonspecific suicide warning for all epilepsy drugs is simply not justifiable. The results are not surprising. Different drugs affect cells in different ways. So there’s no reason to expect that every drug would increase suicide risk for every patient,” says Dr. Michael Sperling, MD, a professor in the Department of Neurology and Director of the Clinical Neurophysiology Laboratory and the Comprehensive Epilepsy Center at Thomas Jefferson University
Thus lack of evidence in certain drugs for suicidality may create an even worse fear among the patients to take their medications. The study thereby emphasizes that risk of uncontrolled epilepsy and seizures are greater than the risk of suicidality from anti-seizure medications and it has to be balanced.
Source: Medindia