The Canadian Medical Association Journal has issued a report suggesting that Pfizer’s smoking cessation drug varenicline, which is sold under the brand name Chantix, is associated with a 72-percent higher adverse cardiovascular events than the placebo.
The analysis of data was drawn from 14 clinical trials of more than 8,000 participants. Thirteen of the trials excluded people with a history of heart disease. The adverse cardiovascular events included in the Journal’s findings were ischemia, arrhythmia, congestive heart failure, sudden death and cardiovascular-related death.
Of the 4,908 people who took Chantix during the trial, 52 experienced serious cardiovascular events such as arrhythmia, compared with 27 of 3,308 people who took a placebo. (A placebo is a simulated medical intervention without any active drug. Sometimes, people taking a placebo will perceive and report improvement despite no real intervention. The placebo serves as a control to help determine the effectiveness of the active drug.)
The adverse heart conditions associated with Chantix are the latest in a string of complaints that have emerged since the FDA approved Chantix for use to help people quit smoking in 2006.
Other reported problems include behavior changes, including hostility, agitation, depression, and suicidal thoughts. Chantix carries a warning for the psychological side-effects.
Pfizer is challenging the Journal’s conclusions.
Sheller, P.C. currently is investigating possible claims related to Chantix. If you or someone you know has taken Chantix and suffered an adverse heart condition, call 1-800-883-2299.