FDA Panel: No Black-Box Suicide Warning on Anticonvulsants
In a moment of righteous perspective, an FDA advisory panel voted yesterday against adding a so-called black box to the labels of 11 anticonvulsive agents,* warning of suicide risks. According to the WSJ, the vote breakdown was 14 against, 4 in favor, and 3 abstaining. Other news sources report that the panel vote was segregated by profession, with clinicians voting against the black box and statisticians in favor. The panel was, however, receptive to sending a pamphlet-type medication guide to physicians, detailing the small risk of suicide associated with anticonvulsant use.
The advisory panel was convened to assess the FDA's meta-analysis of 199 placebo-controlled studies of patients with epilepsy, selected psychiatric illnesses, or pain conditions. In its analysis, the FDA found that there were 4 (0.009%) suicides in drug-treated patients and none in placebo-treated individuals. Suicidal behavior or ideation was reported in 0.37% of patients who received an anticonvulsant and in 0.22% of those who received placebo. While the risk of suicidality was almost 70% higher with anticonvulsant treatment, the absolute risk remained small at 0.15%. Despite voting against a black-box warning, yesterday's panel did confirm the FDA's findings.
*The 11 drugs are carbamazepine (Carbatrol; Shire); felbamate (Felbatol; Meda); gabapentin (Neurontin; Pfizer), lamotrigine (Lamictal; GSK); levetiracetam (Keppra; UCB); oxcarbazepine (Trileptal; Novartis); pregabaline (Lyrica; Pfizer); tiagabine (Gabitril; Cephalon); topiramate (Topamax; Ortho-McNeil); valproate (Depakote; Abbott); and zonisamide (Zonegran; Eisai).
