FDA approves removal of boxed warning regarding serious neuropsychiatric events from Chantix labeling

Labeling revisions also include updates to corresponding warning and addition of clinical data on superior efficacy of Chantix compared with bupropion or nicotine patch.

“For millions who smoke, stopping smoking is one of the most important steps they can take to improve their health, and Pfizer is committed to helping smokers in their quit journey,” said Freda Lewis-Hall, chief medical officer and EVP, Pfizer Inc. “We are pleased with the FDA’s decision to update the Chantix labeling based on EAGLES – the largest clinical trial of smoking cessation medications - and we expect this new information may further facilitate an informed discussion about quitting with Chantix between smokers and healthcare providers.”

“While the benefits of quitting are immediate and substantial, few smokers are able to quit on their own and need the help of counseling and smoking cessation therapy,” said Dr A. Eden Evins, director, Massachusetts General Hospital Center for Addiction Medicine and William Cox Family Associate Professor of Psychiatry in the Field of Addiction Medicine, Harvard Medical School. “As healthcare providers work on the front lines to help people who are struggling to quit smoking, this new labeling provides clinically relevant information on the safety and efficacy of Chantix to help them and their patients make informed decisions about smoking cessation treatment.”

The updated warning in the Chantix labeling notes that postmarketing reports of serious or clinically significant neuropsychiatric adverse events in patients treated with Chantix included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Patients attempting to quit smoking with Chantix should be observed for the occurrence of such symptoms and instructed to discontinue Chantix and contact a healthcare provider if they experience such symptoms.

In EAGLES, in the cohort of patients without a history of psychiatric disorder, CHANTIX was not associated with an increased incidence of clinically significant neuropsychiatric adverse events in a composite endpoint comprising anxiety, depression, feeling abnormal, hostility, agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, and irritability.

In the cohort of patients with a history of psychiatric disorder, there were more events reported in each treatment group compared to the non-psychiatric cohort, and the incidence of events in the composite endpoint was higher for each of the active treatments compared to placebo: Risk Differences (RDs) (95%CI) vs. placebo were 2.7% (-0.05, 5.4) for CHANTIX, 2.2% (-0.5, 4.9) for bupropion, and 0.4% (-2.2, 3.0) for transdermal nicotine. The neuropsychiatric events of a serious nature were reported in 0.6% of CHANTIX-treated patients, with 0.5% involving psychiatric hospitalization. In placebo-treated patients, serious neuropsychiatric events occurred in 0.6%, with 0.2% requiring psychiatric hospitalization.