Welcome to FDA Drug Safety Podcasts for health care professionals. This is Lesley Navin Advanced Practice Nurse from the Division of Drug Information.
On December 16, 2016, the FDA announced that based on our review of a large clinical trial that we required the drug companies to conduct, we have determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (active ingredient varenicline) and Zyban (active ingredient bupropion) is lower than previously suspected. 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 results of the trial confirm that the benefits of stopping smoking outweigh the risks of these medicines.
We are removing the Boxed Warning for serious mental health side effects from the Chantix drug label, and the language describing the serious mental health side effects seen in patients quitting smoking will be removed from the Boxed Warning in the Zyban label. We are also updating both labels to include the results from the clinical trial. This decision is consistent with the recommendations of external experts at a September 2016 FDA Advisory Committee meeting. The Medication Guide will continue to be provided with every prescription; however, the REMS will be removed.
We also confirmed that Chantix, Zyban, and nicotine replacement patches were all more effective helping people quit smoking than placebo. These medicines were found to better help people quit smoking regardless of whether or not they had a history of mental illness.
In 2009, we required a Boxed Warning for Chantix and Zyban after we received and assessed case reports of serious changes in mood and behavior. We required drug companies to conduct a large clinical trial to evaluate these side effects and have confirmed that the benefits of taking Chantix or Zyban to help quit smoking outweigh these risks.
Side effects involving Chantix or Zyban, should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.