Heart Attacks Just Now Understood As Chantix Side Effect

Last month, the FDA did take some action on risks associated with Chantix cardiovascular problems by warning that people with pre-existing heart problems could face a higher risk of cardiovascular events if they take the drug. The information, which was added to the “Warnings and Precautions” section of the Chantix label, was based on a study that assessed Chantix for smoking cessation in 700 patients aged 35 to 75 years with stable, documented cardiovascular disease. Chantix 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 extreme cases, Chantix suicide.

Concerns have been expressed about the method that Pfizer chose to review the safety of their anti-smoking drug.  During the longest Chantix safety and efficacy trial, which assesed the severity of Chantix side effects, they specifically excluded many people who were potential target users of the drug, including those with a history of drug or alcohol abuse, those with cardiovascular disease within six months and those recently treated for psychiatric symptoms like depression, bipolar disorder, psychosis or panic disorders.  They also prohibited the use of other psychologically active drugs during the clinical trial. Between May 2006 and December 2007, the FDA received the following serious adverse event reports associated with the use of Chantix: 227 reports of suicidal acts, thoughts or behavior, 397 cases of possible psychosis and 525 reports of hostility or aggression.

A Wake Forest/Johns Hopkins study involved a meta-analysis of 14 earlier Chantix trials that included more than 8,200 patients (4,908 people on varenicline and 3,308 taking placebos). All trials, except one, excluded people with a history of heart disease, and none of the studies followed participants for longer than one year. The majority of study participants were men and averaged less than 45 year. The study also found that people with no signs of heart problems possibly face the highest risks from Chantix.