Chantix Safety and Effectiveness Information Updated on Drug Label

The label for Chantix, Pfizer’s popular smoking cessation drug, has been updated to include new information about the safety and effectiveness of the medication, as well as warnings about the potential Chantix heart risks for people with heart disease.

The FDA announced the new Chantix label last week, after analyzing a study that found an increased risk of heart events among those with cardiovascular disease. However, the label will also include information from a study whose findings indicate that Chantix is effective in helping people suffering from chronic obstructive pulmonary disease (COPD) to quit smoking and recommends that all Chantix users set a quit date of one week after they begin using the drug.

The new information came from the results of three separate clinical trials, whose findings have all been added to the Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies, and Patient Counseling Information sections of the Chantix physician label. Updated information has also been added to the patient Medication Guide.

The labels will warn that that there was a small increase in the risk of heart attacks for those with cardiovascular disease, but also notes that smoking is a major risk factor for cardiovascular disease as well.

Information will also be added about a clinical trial for Chantix users suffering from COPD, which found that the medication was more effective in helping that population quit than a placebo and found no additional risks than those already associated with Chantix.

Chantix (varenicline) was approved in the United States by the FDA in 2006 as a prescription medication to help people quit smoking. The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine. However, the impact of the drug on the brain has resulted in a number of reports from users who experienced sudden, unusually aggressive behavior, thoughts of self-harm and suicide. Growing concerns over the drug have led to an ongoing investigations into the side effects of Chantix in the United States.

The prescription medication, which is designed to help people stop smoking, already holds the dubious title of being the drug associated with the most FDA adverse event reports of any prescription medication in the United States, including powerful painkillers and other drugs used to treat more serious conditions. More patients and doctors call or write the agency to complain about Chantix health problems than any other drug currently on the market by a wide margin.

A number of Chantix lawsuits have been filed in courts throughout the United States on behalf of individuals who have died or suffered serious injuries as a result of a suicide or unusual behavior allegedly caused by Chantix. In recent weeks, some lawyers have begun reviewing the potential for Chantix heart lawsuits as well.