June 18, 2011- The drug Chantix made by Pfizer, Inc can cause slight increases in cardiovascular problems like heart attacks in patients who already suffer from cardiovascular disease, the Food and Drug Administration announced. The FDA, after reviewing the results from a recent clinical trial, will change the label for Chantix.
An independent trial of 700 smokers already with cardiovascular disease who received treatment with Chantix or a placebo indicated that Chantix was effective in aiding patients to stop smoking for up to a year but the patients taking the drug were slightly more prone to have a heart attack or another cardiovascular event versus the patients just taking a placebo. A good portion of people that try to quit smoking do so to try and prevent the risk of heart attacks.
The FDA said the benefits that are known about Chantix need to be weighed against the potential risk in smokers with cardiovascular disease. The drug regulators also said Pfizer must evaluate the safety of Chantix through conducting large randomized, placebo controlled trials.
The pill has already been criticized for its psychiatric side effects which have hurt global sales and the FDA was prompted to issue a black box warning label for the drug. Chantix has been associated with depression, suicidal thoughts, agitation and nightmares.