Provides Specific Instruction to Physicians and Patients About Quitting Smoking with CHANTIX

Pfizer Inc announced that it has updated the U.S. product labeling for CHANTIX^® (varenicline), a prescription aid to smoking cessation treatment, to communicate important safety information in a boxed warning as well as in revised warnings and precautions. These updates are based on post-marketing reports and are being made in agreement with the U.S. Food and Drug Administration (FDA). Pfizer is making this information available immediately to U.S. health care providers and patients through multiple communication channels, including letters to doctors and pharmacists, Web site updates, and the CHANTIX patient Medication Guide.

The updated label highlights safety information about reports of serious neuropsychiatric events in a boxed warning; updates the warning about reports of neuropsychiatric symptoms and suicidality; adds warnings about reports of allergic reactions and serious skin reactions; and updates precautionary information about driving or operating machinery to include details about reports of accidental injury.

“The labeling update underscores the important role of health care providers in treating smokers attempting to quit and provides specific information about CHANTIX and instructions that physicians and patients should follow closely,” said Dr. Briggs W. Morrison, senior vice president, Primary Care Development Group at Pfizer. “Quitting smoking is one of the best things people can do for their health, but the quitting process is both difficult and complex.”

Boxed Warning Highlights Important Safety Information

Certain information on neuropsychiatric symptoms has been included in the CHANTIX label since November 2007 and is based on post-marketing reports. The boxed warning instructs health care providers to observe patients being treated with CHANTIX for the possibility of certain serious neuropsychiatric events and to advise patients to stop taking CHANTIX and contact their doctor immediately if these symptoms occur. It also states that the safety and efficacy of CHANTIX in patients with serious psychiatric illness have not been established. The update advises physicians to provide ongoing monitoring and support for patients who exhibit neuropsychiatric events until symptoms resolve.

The boxed warning also provides important information about the quitting process. It states that some smokers who are making a quit attempt – including those who are not using medication – may experience nicotine withdrawal symptoms, such as depressed mood.