FDA warns of Zyban, Champix depressive side-effects
The U.S. Food and Drug Administration will require two smoking-cessation drugs, Champix and Zyban, to carry the agency's strongest safety warning over side-effects including depression and suicidal thoughts.
The new requirement, announced Wednesday, "will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs," the FDA said in a statement on its website.
Despite the new, stricter warnings, the FDA said consumers and doctors still have to weigh the benefit versus the risks when taking the drug.
"The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking," said Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research.
The antidepressant Wellbutrin, which has the same active ingredient as GlaxoSmithKline PLC's Zyban, already carries such a warning.
The FDA said it is also requiring an additional study on Champix and Zyban to determine the extent of the side-effects. Pfizer Inc., which makes Champix, said it is still discussing the potential study design with the FDA.
The study could include patients with and without psychiatric conditions to determine the true incidence rate of psychological side-effects, Pfizer officials said.
Pfizer had already updated its labeling following the beginning of an FDA investigation into the potential side-effects in 2007.
That investigation was sparked by reports of about 37 suicides and more than 400 of suicidal behavior in connection with the drug.