Academics Challenge FDA Suicidality Drug Warning
Researchers from several academic medical centers and other sites say there is no evidence to support an FDA class warning for suicidality in newer anti-seizure drugs. “Without the evidence to support it,” says Thomas Jefferson University professor Michael Sperling, one of the study authors, “the net effect of such class risk on drugs has consequences that may be worse if patients are afraid to take their medication.” The researchers say they hope FDA will reconsider its blanket warnings on classes of drugs.
“The approach FDA has taken is concerning for doctors and patients alike because it’s not evidence-based,” Sperling says in a statement issued by his university.
The researchers report that in 2008 FDA analyzed results from nearly 200 clinical trials that assessed the efficacy of many drugs, including 11 anti-seizure medications. The analysis found that compared with placebo the anti-seizure medications nearly doubled suicide risk among patients being treated for epilepsy, psychiatric disorders, and other diseases including chronic pain. FDA concluded that anti-seizure medications increase suicide risk but the authors say that subsequent analyses did not find the same results.
The report says the presence of the FDA Warning affected the way new drugs are developed and that then affected patient treatment. “Trials of anti-seizure drugs since the Warning came out have been careful to assess suicidality,” Sperling says, “but have also excluded people with histories of suicidal ideation. This means that trial results are difficult to extrapolate to patient treatment.” Another concern, he says, is that patients may be reluctant to start or keep taking anti-seizure medications because of the Warning. But for patients with epilepsy, not taking their medication could mean more seizures and even a risk of dying from increased seizures.
The researchers reviewed all Phase 2 and 3 trials of the five new anti-seizure medications approved by FDA since 2008 that assessed suicidality. In their evaluation of 17 studies involving nearly 6,000 patients, they found no evidence for increased risk of suicidal thinking or behavior in the five drugs.
“Our findings indicate the non-specific suicide Warning for all epilepsy drugs is simply not justifiable,” Sperling says. “The results are not surprising. Different drugs affect cells in different ways. So there’s no reason to suspect that every drug would increase suicide risk for every patient.”