Research shows the anti-smoking drug varenicline tartrate—sold under the brand name Chantix (Champix outside the U.S.)—causes heart-related and psychological side effects.
What Is Chantix? When Is It Prescribed?
Chantix is a brand name for the drug varenicline tartrate. Made and sold by the pharmaceutical giant Pfizer, Inc., this prescription medication is used to treat nicotine addiction. In February 2006, the U.S. Food and Drug Administration (FDA) granted varenicline priority review, a process that shortens the 10-month drug evaluation process to six months. Officials thought varenicline was safe and demonstrated effectiveness in previous trials. It took only three months for the FDA to approve the drug, and it appeared on shelves in August 2006 (September in Europe).
Varenicline comes in 0.5 mg or one mg oral tablets, taken over 12 weeks. Once ingested, it binds with nicotinic acetylcholine receptors, the same ones nicotine from cigarettes and other tobacco products bind to. Unlike nicotine, though, it does not produce the same effects, such as encouraging dopamine release. Among other things, dopamine regulates moods. When Chantix users consume tobacco products, the varenicline displaces the nicotine, resulting in reduced cravings and enjoyment of the tobacco. This helps users quit.
Pfizer has found a real money-maker in Chantix. A one-month supply can cost $120, and doctors worldwide have issued millions of prescriptions. Pfizer sold $887 billion dollars worth of the drug in 2007—well above the $101 billion of the drug the company sold in the last half of 2006. Sales overseas are expected to grow significantly due to an increase in Japan’s cigarette tax. In fact, Pfizer faces a shortage of the drug.
Despite the surge in demand, however, controversies have eroded consumer confidence in varenicline. In 2009, the FDA placed a “black box warning,” the agency’s most serious alert, on Chantix. There has been no Chantix recall, though multiple Chantix lawsuits have been filed against Pfizer, including a Chantix class action lawsuit in Canada.
Chantix Might Cause Serious Heart Problems
In June 2011, the FDA issued a drug safety communication stating that Chantix “may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section of the Chantix physician labeling.”
In August 2011, a study published in the Canadian Medical Association Journal showed that Chantix users are at a 72 percent greater risk of eventually suffering from serious heart problems. The study analyzed the data of 4,908 healthy people who took Chantix and 3,308 participants who took a placebo. Of the Chantix users, 52 developed serious heart problems, while only 27 of the people who took the placebo developed serious heart problems. From these numbers, it seems that Chantix users were proven to be at only a 0.24 percent greater risk of heart problems. The study’s researchers, however, analyzed data from 14 previous studies and—using a statistical method specifically designed for analyzing multiple studies—determined that using Chantix increases a patient’s chances of developing a serious heart condition by 72 percent.
On December 2, 2012, the FDA updated its Chantix drug safety communication by announcing that it had concluded a meta-analysis of numerous studies on Chantix alleged tendency to cause heart-related side effects. It found “A higher occurrence of major adverse cardiovascular events (a combined outcome of cardiovascular-related death, nonfatal heart attack, and nonfatal stroke) … in patients using Chantix compared to placebo.” The FDA described this higher occurrence as rare and not statistically significant. The agency nevertheless recommended health care professionals to weigh the risks Chantix poses against the benefits it provides by improving the quality of life of smokers.
Some Chantix Users Suffer Serious Psychological Side Effects
On July 1, 2010, the FDA required a black box labeling change on Chantix. Officials found that the drug caused serious psychological side effects, much like those that occur when an antidepressant malfunctions. Users found they were experiencing drowsiness, vivid or disturbing dreams, hostility, depression, and suicidal ideations and behaviors.
The FDA did not know if these side effects were caused by the drug or by nicotine withdrawal, or both, but by the time the Chantix warning appeared, the government had received reports of 98 suicides, 188 attempted suicides, and dozens of cases of paranoia and hallucinations. In the majority of cases, the psychological changes occurred during the time period people were using the drug. It is likely that the effects varenicline has on dopamine are responsible.
By 2008, the Institute for Safe Medical Practices (ISMP) determined that more patients lodge serious complaints about varenicline than any other drug on the market, and on June 4, 2009, the FDA began retesting varenicline for other side-effects such as skin conditions, heart problems, diabetes, seizures, visual impairment, and accidental injuries. According to an LA Times article, the ISMP also discovered that varenicline caused two dozen car accidents, and the Washington Times ran an article about how the Department of Veteran Affairs had tested varenicline on former soldiers without informing them of the side effects; one suffered a psychotic breakdown. The government became so concerned about Chantix that, fearing accidents, the Federal Aviation Administration banned its use by pilots. Subsequent ISMP reports tell the same story: record numbers of adverse reports and tragic suicides.
Because of the seriousness of these side effects, 2,700 Chantix users sued Pfizer for compensation. According to a Thompson Reuters article, Pfizer’s recent annual filing with U.S. Securities and Exchange Commission disclosed that it had settled 80 percent of the Chantix lawsuits it faced for more than $273 million. It also set aside another $15 million for the remaining cases. Before the filing became public, Pfizer had just announced settlements in two cases that were slated to proceed as bellwethers for other plaintiffs.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers of the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Chantix lawsuit on your behalf if necessary.
If you have taken Chantix and believe it harmed you, contact RLG today.