Chantix Heart Attack Warning Issued By FDA

Concerns over a potential increased risk of heart attacks and other cardiovascular problems among some users of the smoking cessation drug Chantix has led federal regulators to require new warnings for smokers who are considering the prescription medication. 

The FDA issued a Chantix drug safety communication on June 16, warning that the Pfizer drug might increase the risk of certain heart problems, including the risk of heart attack, among individuals who have cardiovascular disease.

The new information will be added to the Warnings and Precautions section of the drug’s label, as well as to a Medication Guide that is given out with every prescription for the drug, due to the potential risk of suicide and abnormal behavior from Chantix.

A clinical trial involving 700 smokers with pre-existing cardiovascular disease found that those treated with Chantix to help them quit smoking faced an increased risk of certain heart problems, including heart attacks at a rate more than twice that of those who were given a placebo. Other potential Chantix heart problems identified during the study include more incidents of coronary revascularization, as well as more treatments for peripheral vascular disease.

The FDA encouraged smokers to continue using Chantix to attempt to quit, but warned that they should immediately contact a health care professional if they experienced shortness of breath, trouble breathing, new or worsening chest pain, or new or worsening pain in the legs while walking.

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.

In June 2009, the FDA added a “black box” warning about the potential risk of psychiatric problems with Chantix, indicating that some users have experienced changes in behavior, depression and suicidal thoughts. Pfizer has also been required to conduct clinical trials providing more data on how often neuropsychiatric symptoms and suicide with Chantix occur and what conditions cause them.

The Chantix heart attack concerns come shortly after France declared it would stop reimbursing citizens who used Chantix to quit smoking, saying that its psychological side effects outweighed its benefits.

Chantix already holds the dubious title of being the drug associated with the most FDA adverse event reports. More patients and doctors call or write the agency to complain about Chantix side effects than any other drug currently on the market by a wide margin.

A growing 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 October 2009, the U.S. Judicial Panel on Multidistrict Litigation consolidated the federal Chantix litigation in the U.S. District Court for the Northern District of Alabama. According to a pretrial scheduling order issued earlier this year, the first Chantix trial is unlikely to reach a jury until at least 2012.