(RxWiki News) The risk for mental health side effects tied to stop-smoking medications may be lower than once thought, according to a recent review of a large clinical trial.
That review led the US Food and Drug Administration (FDA) to revise its description of the mental health side effects associated with Chantix (varenicline) and Zyban (bupropion).
The FDA notes in its revised description that the risk for mental health side effects (changes in mood, behavior or thinking) is still present, especially for those who are currently being treated for mental illnesses or who have been treated in the past for mental illnesses like anxiety, depression or schizophrenia. But the consequences of this risk may not be as serious as previously believed.
In the clinical trial the FDA reviewed, these mental health side effects were not associated with serious consequences like hospitalization, and the benefits appeared to outweigh the risks.
The trial suggested that these medications were more effective than a placebo in helping patients stop smoking. Quitting smoking can lower cancer and heart disease risk and improve circulation and breathing.
Based on the results of the recent trial, the FDA is removing a boxed warning about serious mental health side effects from the labels for both Chantix and Zyban. The warning sections will include the results of the recent trial.
If you are taking varenicline or bupropion and experience any mental health side effects, the FDA recommends stopping the medication and notifying your health care provider.
If you want to stop smoking, speak with your health care provider to see if stop-smoking medications can help you. In addition, if you have any concerns about these medications, ask your health care provider or pharmacist.
