The FDA is adding a boxed warning on the prescribing information for the smoking-cessation drugs varenicline (Chantix, Pfizer) and bupropion (Zyban drug, GlaxoSmithKline) to highlight the risk of serious mental health events, such as behavioral changes, depressed mood, hostility, and suicidal thoughts.
Asenapine tablets (Saphris, Schering-Plough) have been approved to treat both schizophrenia and bipolar I disorder in adults.
A boxed warning is included to alert prescribers about an increased risk of death associated with the off-label use of this atypical antipsychotic medication for treating behavioral problems in older people with dementia-related psychosis. Asenapine is not approved for these patients.
Canadian Pharmacy Blog