In June 2011, the FDA added a warning that Chantix (varenicline)*, one of the most popular smoking cessation drugs, "may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease." On July 4, 2011 the Canadian Medical Association Journal published a study that seemed to validate the June FDA warning. The study concluded smokers who take Chantix could increase their risk of heart problems (i.e., heart attacks, irregular heartbeats, etc.). Researchers examined data from clinical trials involving 8,216 healthy people who received either Chantix or a placebo. The authors wrote that "The use of varenicline among tobacco users was associated with a 72% increased risk of serious adverse cardiovascular events". The study’s findings are similar to the U.S. Food and Drug Administration's (“FDA”) review of a randomized clinical trial of 700 smokers that found slightly more heart problems in the Chantix group than those taking the placebo. Since the approval of Chantix in 2006, there has been a growing list of concerns raised by patient reports, lawsuits and studies. Besides these recent concerns involving heart problems, according to the Chantix warning label, it could cause changes in behavior, hostility, agitation, depressed mood, suicidal thoughts or actions. In fact, Chantix carries a boxed warning -- the FDA’s most restrictive safety labeling -- because of the risk of psychological events. The Federal Aviation Administration has banned pilots and air-traffic controllers from using Chantix because it may cause loss of consciousness and blackouts. Operators of heavy machinery such as bus drivers and truckers are also not allowed to take Chantix. Apparently the FDA is working with Pfizer to design a comprehensive look at existing research to evaluate the safety of Chantix. If you or someone you know was prescribed Chantix and experienced a heart-attack, arrhythmia, or stroke, you may have a legal claim. Please complete the form below or call us toll-free at (800) 351-8588 for a free, no-obligation, consultation. *Varenicline (trade name Chantix in the USA and Champix in Canada, Europe and other countries, marketed by Pfizer, usually in the form of varenicline tartrate), is a prescription medication used to treat smoking addiction. |
