Not All Anti-Seizure Drugs Carry the Risk of Suicidality

Evidence for FDA’s (U.S. Food and Drug Administration’s) suicide-risk warning on anti-seizure medications may be lacking and hence may not apply to many anti-seizure drugs as per a study at the Thomas Jefferson University, published in the journal JAMA Neurology.

Since the FDA’s warning is not evidence-based, the findings call on the FDA to change its approach for applying class warnings to medication.

Focal Seizures | Partial Seizures - Types, Causes, Symptoms, Complications, Diagnosis, Treatment and Prevention
Focal or partial seizures are abnormal localized electrical discharges in the brain. They are of two types and exhibit many associated symptoms. Focal seizures can be diagnosed by EEG and brain imaging and treated with drugs and lifestyle changes.

‘Evidence for FDA’s (U.S. Food and Drug Administration’s) 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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Nearly 200 clinical trials by FDA in 2008 had assessed the efficacy of many drugs including 11 anti-seizure medications. It was found that suicide risk among patients being treated for epilepsy was doubled with anti-seizure medications when compared with placebo.

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

Epilepsy In Children | Seizures In Children - Causes, Complications, Types, Diagnosis, Treatment and Prevention
Epilepsy or seizures are caused by abnormal electrical activity in the brain and seen fairly commonly in children. Symptoms can be highly variable and parents should seek prompt medical advice to treat the condition

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 17 randomized, 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.

Absence Seizure - Causes, Symptoms, Diagnosis, Treatment & Prevention
Absence seizure (petit mal epilepsy) involves sudden lapse in consciousness and staring blankly into space, the episodes lasting less than 15 seconds.

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

Febrile Fits - Causes Symptoms Diagnosis Treatment Prevention
High fever in kids can cause convulsions and are called febrile fits that do not include the seizures that occur as a result of brain infection.

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