FDA approves removing boxed warning from Chantix

Pfizer can remove the boxed warning regarding serious neuropsychiatric events from Chantix, according to a press release. The company also said that product’s labels can now include data showing it is much more effective than the nicotine patch and bupropion and a corresponding warning tied to neuropsychiatric safety.

The FDA approval follows a FDA committee recommendation this past September.

“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,” A. Eden Evins, MD, MPH, and director, Massachusetts General Hospital Center for Addiction Medicine, said in a press release. “As health care 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.”

According to the company, the results of Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES), were critical to the FDA’s decision. Results from the study showed that in patients without a history of psychiatric disorder, Chantix (varenicline, Pfizer) was not associated with an increased incidence of clinically significant neuropsychiatric adverse events in a composite endpoint comprising irritability, panic, mania, homicidal ideation, hallucinations, delusions, aggressions, hostility, feeling abnormal, depression and anxiety..

Pfizer said the updated warning will note post-marketing reports of serious or clinically significant neuropsychiatric adverse events in patients treated with the drug, including panic, anxiety, agitation, hostility, aggression, homicidal ideation, delusion, paranoia, hallucinations, psychosis and changes in mood (including depression and mania). Those trying to stop smoking and using Chantix should be watched for these symptoms and told to discontinue the drug and contact a health care provider if they experience them, according to the release.

The boxed warning had been on Chantix since 2009 to draw attention to the risk of serious mental health events that included changes in behavior, hostility, depressed mood and suicidal thoughts.

For more stories Healio Family Medicine has done on smoking cessation methods, click here.

Disclosure: Healio Family Medicine was unable to confirm Evins’ disclosures prior to publication.