FDA Calls It Quits on Black-Box Warnings for Smoking Cessation Drugs

In news that may boost efforts to tackle a leading cardiovascular disease risk factor, the US Food and Drug Administration (FDA) has determined that the risk of mental health side effects with certain smoking cessation drugs is “lower than previously suspected.”

In an alert late last week, the agency announced that it will be removing the Boxed Warning referencing serious mental health side effects from the labels of both varenicline (Chantix, Pfizer) and bupropion (Zyban, GlaxoSmithKline). Language warning about behavioral changes, depressed mood, hostility, and suicidal thoughts was added to the medications in 2009, amid controversy, with smoking cessation advocates worried that the small risk of these side effects was far less than the risks of continued smoking.

Following the results of the EAGLES randomized, double-blind, placebo-controlled trial of more than 8,000 patients mandated by the FDA to explore the problem, the agency concluded that the benefits of stopping smoking outweigh the risks of the two medicines. Earlier this year, the FDA’s Psychopharmacologic Drug Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted in favor of removing the boxed warnings.

New labelling on both drugs will include the results of the clinical trial, while the medication guide will no longer include a risk evaluation and mitigation strategy (REMS). The agency notes, however, that some risk of mental health side effects persists, but predominantly in people who are currently being treated for mental illness or have been treated in the past.