New Chantix Side Effects Increased Cardiovascular. A published report states that users of the smoking cessation drug Varenicline, brand name Chantix, has been linked to a small but statistically significant increased risk of cardiovascular events. The study was conducted by CMAJ suggests that 1 in every 28 patients receiving Chantix would experience a serious cardiovascular risk such as a stroke or heart attack.
If you take Chantix or Zyban in an effort to quit smoking and have experienced psychiatric problems, you should know that these drugs could be to blame. Additionally, new evidence suggests that Chantix and Zyban have been linked to serious cardiovascular, heart disease, stroke and heart attack risk, as well as, mental health events including changes in behavior, depression, hostility, and suicidal thoughts.
Mental Health Side Effects
The mental health side effects have been so serious that in July 2009, the Food & Drug Administration (FDA) mandated that a Black Box Warning – the agency’s most serious safety notice – be added to the label of Chantix and Zyban highlighting their association with mental health problems. The cardiovascular risks prompted the Food & Drug Administration to issue a warning to physicians in June 2011 that users of Chantix or Zyban face an increased risk of heart problems such as strokes and heart attacks.
Parker Waichman is currently investigating Chantix lawsuits on behalf of people who have suffered serious mental health problems and cardiovascular problems as a result of these medications. Since Chantix and Zyban did not come with stronger warnings about their psychiatric or cardiovascular side effects, it is possible that many users have no idea that the mental health problems or heart disease problems they experienced may have been caused by these drugs.
Chantix is a smoking cessation medication marketed by Pfizer, Inc. that was approved by the FDA in 2006. Chantix works by blocking nicotine receptors, thereby reducing cravings for and decreases the pleasurable effects of cigarettes and other tobacco products. Chantix was the first such nicotine receptor partial agonist approved by the FDA. It is an alternative to other smoking cessation drugs and nicotine replacement therapy.
Shortly after it was introduced to the market, some Chantix patients reported that they had experienced strange side effects, including erratic behavior, suicidal thoughts and depression, while taking the drug. In November 2007, the FDA announced that it had begun a Chantix safety review because of these reports.
In 2008, Pfizer elevated the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, wanted the FDA to go further and highlight the Chantix suicide risk with a Black Box Warning.
Zyban, manufactured by GlaxoSmithKline, was originally marketed as an antidepressant under the name Wellbutrin. In 1997, the FDA approved Zyban to be used as a quit smoking aid, and since then, it has become a popular method to help smokers kick the habit. Zyban, when used in combination with other nicotine replacement therapies (NRT’s), such as the nicotine patch or nicotine gum, increases the chances for long term success with smoking cessation.
FDA Warning For Chantix and Zyban
In July 2009, the FDA announced it had mandated a Black Box Warning for the labeling of Chantix and Zyban to highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs
The FDAs request for the additional warnings was based on a review of reports submitted to the agency. Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature.
The analyses revealed that some who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. According to media reports, the FDA had received 98 reports of suicide among patients taking Chantix and 188 reports of attempted suicide, and 14 suicides and 17 suicide attempts among patients taking Zyban.
In many cases, the FDA said the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.
Neither Chantix nor Zyban contain nicotine and some of these symptoms may be a response to nicotine withdrawal, the FDA said. People who stop smoking may experience symptoms such as depression, anxiety, irritability, restlessness, and sleep disturbances. However, some patients who were using these products experienced the reported adverse events while they were still smoking, the FDA said.
In addition to the Boxed Warning, the FDA also requested more information in the Warnings section of the prescribing information and updated information in the Medication Guide for patients that further discuss the risk of mental health events when using Chantix or Zyban.
Need Legal Help Regarding Chantix Side Effects?
The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).
