As my regular readers are aware, I have always maintained the position that Chantix was a drug that simply didn’t need to be on the market. Sure, smoking is an independent risk factor for a number of serious medical conditions. But with the high risk of suicide and suicidal thoughts that so frequently occur in patients taking Chantix, I thought the risk benefit analysis failed.
Today, the FDA added a new safety wrinkle into the safety profile of Chantix. The U.S. Food and Drug Administration (FDA) notified the public that Chantix may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section of the Chantix physician labeling.
Before insisting on this new warning, the FDA reviewed a randomized clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix or a placebo. Certain serious cardiovascular adverse events, including heart attack, were reported more frequently in patients treated with Chantix than in patients treated with the placebo.
 
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