Archive 1995–2023

Varenicline and bupropion are non-nicotinic drugs approved for treatment of tobacco dependence, but there are post-marketing case reports of suicidality associated with the usage of these drugs. For this reason, Food and Drug Administration and European Medicines Agency decided to add "Boxed Warnings" to product labelling to alert healthcare professionals and patients about possible psychiatric symptoms. Lately, rimonabant, a CB1 receptor antagonist, has been withdrawn from the market because of an increased risk of depression and suicidality. However, concerns about the safety of varenicline and bupropion are mostly based on case reports and currently benefits of smoking cessation are thought to be greater than the risk of psychiatric adverse effects associated with varenicline and bupropion therapy.