Pfizer Updates CHANTIX(R) (varenicline) Labeling In The United States

Main Category: Smoking / Quit Smoking
Article Date: 02 Jul 2009 - 6:00 PDT

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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. Additionally, the boxed warning communicates that the health benefits of quitting smoking are immediate and substantial, the risks of CHANTIX should be weighed against the benefits of its use, and that CHANTIX has been demonstrated to increase the likelihood of quitting for as long as one year compared to placebo.

Pfizer is conducting clinical trials of CHANTIX in multiple populations, including in patients with psychiatric disorders and chronic lung disease.

Safety Information in Warnings and Precautions Sections

The CHANTIX label updates existing warning information regarding serious neuropsychiatric symptoms to include the types of reports received. It also adds warnings about allergic reactions, such as angioedema, and rare, but serious, skin reactions, such as Stevens-Johnson Syndrome. Existing precautionary information about driving and operating machinery has been updated in the CHANTIX label to include details about accidental injury.

"The health benefits of quitting smoking are immediate and substantial," said Dr. Morrison. "The benefits of CHANTIX outweigh the risks for many patients when used as directed. CHANTIX is an effective treatment option for patients who want to quit smoking. Patients should discuss with their physicians if CHANTIX is right for them."

About CHANTIX

CHANTIX was approved by the FDA in May 2006 as an aid to smoking cessation treatment in adults 18 and older. Nearly 11 million people have been prescribed CHANTIX worldwide. CHANTIX has been shown to increase the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo. Adults who smoke may benefit from quit smoking support programs and/or counseling during their quit attempt. It's possible that patients might slip up and smoke while taking CHANTIX. If patients slip up, they can stay on CHANTIX and keep trying to quit.

About Smoking

Tobacco use is a risk factor for six of the eight leading causes of death in the world, including heart disease, cancer, and chronic obstructive pulmonary disease.1,2 Smoking-related illness is the leading preventable cause of death in the United States, killing more than 443,000 people each year.3,4

References

1. World Health Organization. WHO Report on the Global Tobacco Epidemic, 2008: The MPOWER Package. Geneva, Switzerland: World Health Organization; 2008.

2. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Medicine, 2006;3(11):e442. (Additional information obtained from personal communication with CD Mathers).

3. Centers for Disease Control and Prevention. Surgeon General's 2004 Report: The health consequences of smoking on the human body. Centers for Disease Control and Prevention, U.S. Dept of Health and Human Services, Rockville, MD:2004.

4. Centers for Disease Control and Prevention. Smoking-Attributable Mortality, Years of Potential Life Lost, and Productivity Losses-United States, 2000-2004. MMWR. 2008; 57(45); 1226-1228.

Source
Pfizer