FDA issues new information on varenicline (Chantix, Pfizer)
The FDA has issued an Early Communication following reports of suicidal ideation and behavior in patients taking varenicline (Chantix, Pfizer) and one report of erratic behavior that led to the death of a patient using the smoking-cessation drug. According to the agency, a preliminary assessment reveals that many of the cases show new-onset of depressed mood, changes in emotion and behavior, and suicidal ideation shortly after beginning treatment. However, the exact link to the drug is unknown since smoking cessation itself is associated with nicotine withdrawal symptoms and can exacerbate underlying psychiatric illness. While the agency works to complete the analysis of materials submitted by Pfizer, healthcare professionals should, in the meantime, monitor patients taking varenicline for changes in behavior and patients should contact their physician if they notice any such changes. The FDA is also evaluating reports of drowsiness associated with varenicline and suggests patients use caution when driving or operating machinery.