Pfizer Updates CHANTIX (R) (varenicline) Labeling in the United States

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)

IMPORTANT SAFETY INFORMATION

Some people have had changes in behavior, hostility, agitation, depressed mood, suicidal thoughts or actions while using CHANTIX to help them quit smoking. Some people had these symptoms when they began taking CHANTIX, and others developed them after several weeks of treatment or after stopping CHANTIX. If you, your family or caregiver notice agitation, hostility, depression or changes in behavior, thinking, or mood that are not typical for you, or you develop suicidal thoughts or actions, anxiety, panic, aggression, anger, mania, abnormal sensations, hallucinations, paranoia or confusion, stop taking CHANTIX and call your doctor right away. Also tell your doctor about any history of depression or other mental health problems before taking CHANTIX, as these symptoms may worsen while taking CHANTIX.

Some people can have serious skin reactions while taking CHANTIX, some of which can become life-threatening. These can include rash, swelling, redness, and peeling of the skin. Some people can have allergic reactions to CHANTIX, some of which can be life-threatening and include: swelling of the face, mouth, and throat that can cause trouble breathing. If you have these symptoms or have a rash with peeling skin or blisters in your mouth, stop taking CHANTIX and get medical attention right away.

The most common side effects include nausea (30%), sleep problems, constipation, gas and/or vomiting. If you have side effects that bother you or don't go away, tell your doctor. You may have trouble sleeping, vivid, unusual or strange dreams while taking CHANTIX. Use caution driving or operating machinery until you know how CHANTIX may affect you.

CHANTIX should not be taken with other quit smoking products. A lower dose of CHANTIX may be necessary in patients with kidney problems or who get dialysis.

Before starting CHANTIX, patients should tell their doctors if they are pregnant, plan to become pregnant, or if they take insulin, asthma medicines, or blood thinners. Medicines like these may work differently when patients quit smoking.

For more information, please visit www.pfizer.com/files/products/uspi_chantix.pdf for full Prescribing Information and http://www.pfizer.com/files/products/ppi_chantix.pdf for Patient Medication Guide.

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Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, more than 80,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

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 Inc

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