Chantix Side Effects Increase Risk of Heart Attack, Stroke: Study

New research suggests that side effects of Chantix could significantly increase the risk of heart attacks, strokes and other cardiovascular events; echoing concerns raised by the FDA last month. 

Pfizer’s smoking cessation drug Chantix may raise the chances of suffering a cardiovascular event by 72%, according to a study by researchers at Johns Hopkins University School of Medicine, which was published this week in the Canadian Medical Association Journal.

Researchers mined a number of databases for double-blind, randomized controlled trials for people who took Chantix and were later found to have suffered a cardiovascular event, including heart attacks. They found that those who took Chantix were substantially more likely to suffer heart problems than those who took a placebo, and two of the co-authors suggested that the findings were strong enough that the FDA should consider a Chantix recall due to the risk of heart attack and stroke.

The study comes just three weeks after the FDA issued a drug safety communication about the risk of heart problems from Chantix, warning that the smoking cessation drug might increase the risk of certain cardiovascular events, including the risk of heart attack, among individuals who had cardiovascular disease. However, the latest study suggests that those without a history of heart disease may also face a significant risk.

Pfizer has issued a statement questioning the authors’ results and saying that the number of actual events was too small to lead to their conclusions.

The risk of a heart attack or stroke from Chantix is just the latest in a number of serious side effects associated with the popular drug. Warnings about the risk of serious and potentially life-threatening psychological side effects of Chantix, which may increase the risk of suicide, suicide attempts or unusual violent behavior, were added to a black box on the medications label two years ago.

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 investigation in the U.S. and Canada and France has decided not to subsidize its use, effectively killing its presence on the French market.

The prescription medication 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.