Pfizer announces updates to CHAMPIX EU label

Pfizer Inc. yesterday announced updates to the European Union (EU) CHAMPIX label and leaflet.

The changes were prompted by the EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) clinical trial.

The European Summary of Product Characteristics (SmPC) and package leaflet now include the safety and efficacy data obtained from the post-authorization safety study. The black triangle symbol, which indicated additional safety monitoring, has been removed. The trial compared the neuropsychiatric safety of CHANTIX/CHAMPIX and bupropion versus a placebo and nicotine patch. Participants in the study included those with and without a psychiatric disorder diagnosis.

“Smoking remains a major public health challenge, causing more than 5 million deaths worldwide each year,” Pfizer Chief Medical Officer, Internal Medicine, Dr. Rory O’Connor said. “Since its introduction in the EU nearly 10 years ago, CHAMPIX has been prescribed to millions of adults to help them stop smoking. The new safety and efficacy information in the European label further supports the importance of CHAMPIX as a treatment option for health care providers and for those who are trying to quit smoking.”

CHANTIX/CHAMPIX was approved by the U.S. Food and Drug Administration in 2006. The prescription medication helps adults stop smoking. Support programs and counseling can also help smokers abstain from tobacco products. CHANTIX/CHAMPIX can be continued even if a person backslides and then resumes abstention efforts.