FDA Updates Chantix Cardiovascular Warnings in Light of Clinical Trial Results

WASHINGTON, D.C. — After reviewing the results of a meta-analysis of recent clinical trials, the Food and Drug Administration has ordered Pfizer Inc. (NYSE: PFE) to update the Chantix label to advise consumers to contact their doctor “if they experience new or worsening symptoms of cardiovascular disease.”

According to the Dec. 12 safety communication, a higher occurrence of major adverse cardiovascular events was observed in patients using the smoking cessation drug compared to placebo.

“These events were uncommon in both the Chantix and placebo groups, and the increased risk was not statistically significant, which means it is uncertain whether …