The stop-smoking drugs varenicline (Chantix) and bupropion (Zyban) no longer need to carry a boxed warning about serious neuropsychiatric event risk, such as suicidality,
"We have determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected," the agency said.
However, the drugs' labels will still carry information about the risk in the their warnings sections. "The risk of these mental health side effects is still present, especially in those currently being treated for mental illnesses such as depression, anxiety disorders, or schizophrenia, or who have been treated for mental illnesses in the past. However, most people who had these side effects did not have serious consequences such as hospitalization," the FDA said.
The agency said it will also no longer require a Patient Medication Guide detailing the risks as part of the drugs' risk evaluation and mitigation strategy.
Labels will continue to recommend that providers observe patients taking Chantix for such symptoms, and that patients stop the drug if they occur.
The FDA said it was persuaded by results from a trial called EAGLES that found that these psychiatric events were no more common with varenicline or bupropion compared with individuals using nicotine patches or placebo to try to quit smoking. The FDA had required Pfizer and GlaxoSmithKline, which respectively market varenicline and bupropion for smoking cessation, to conduct EAGLES.
An FDA advisory committee, in a split vote, had voted 14-5 in September to recommend that some change be made to the drugs' labels to reflect the EAGLES results. Ten members voted to drop the boxed warning altogether and four others wanted it modified to include results from the trial; five wanted the warning to remain as is.