If there is one thing has greatly contributed to improving public health in America it is the reduced use of tobacco products. Anything that will get people out of the cigarette habit is almost certainly healthier than remaining addicted to cigarettes. It is with the point of view that the public should greet the newest advisory from the FDA about Chantix, a product designed to help people kick nicotine. The FDA today released the result of a meta-analysis of prior studies done on the safety of Chantix. Of particular concern was the suggestion that has been made in the past connecting Chantix to heart problems.
The FDA announcement indicates that while users of Chantix in the various studies did have a higher incidence of heart attacks and strokes, the number was not “statistically significant.” When I, as a trial lawyer, see a report like this my first assumption is that the manufacturer financed a meta-analysis in an attempt to defeat liability claims. Here, the FDA required the company to produce the study.
The take away of this announcement for doctors will be to keep their patients on Chantix if it will help them get away from tobacco use, but also to keep a closer watch on them for signs of cardio-vascular problems. Most patients at this point should see that it is clearly worth the ‘risk” because the risk is not shown to be statistically significant, whereas the risk and detrimental health effects of smoking are considerable and well-established. In keeping an eye on patients, doctors will also be more mindful of reporting adverse events for their patients on Chantix.
The full MedWatch report can be found at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm331626.htm
M. Robert Blanchard is a former prosecuting attorney, trial lawyer and writer living in Gulf Breeze, FL.
