The FDA has determined that the risk of serious side effects on mood, behavior, or thinking with the smoking cessation medicines varenicline and bupropion is lower than previously suspected. Following case reports of serious changes in mood and behavior in patients taking these medicines, led the FDA to require that a Boxed Warning be added to the labels in 2009.
The FDA continues to evaluate the safety and effectiveness of drugs after they go on the market. Recent large clinical trials have demonstrated that 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 trials confirm that the benefits of stopping smoking outweigh the risks of these medicines.
The FDA is also updating the existing warning section in both labels that describes the side effects on mood, behavior, or thinking to include the results from the clinical trial. The patient Medication Guide that explains the risks associated with the use of the medicines will continue to be provided with every patient prescription; however, the risk evaluation and mitigation strategy (REMS) that formally required the Medication Guide will be removed.