Pharmaceutical

FDA warns of new heart risks associated with Chantix

For many smokers trying to kick their addiction, the latest news about the dangers of Pfizer’s smoking-cessation drug Chantix presents as a damned if you do, damned if you don’t dilemma. The U.S. Food and Drug Administration issued an alert yesterday, warning that use of the popular drug could lead to increased risk of heart attack and other adverse cardiovascular events.

The FDA said that a randomized, double-blind, placebo-controlled clinical trial of 700 smokers were given Chantix or a placebo. All of the participating smokers had been previously diagnosed with heart disease. Although results found the risks to be relatively small, after 12 weeks more than twice as many Chantix patients suffered heart-related problems than the placebo patients. Seven out of 353 Chantix patients had a nonfatal heart attack, versus 3 out of 350 of the placebo patients.

Other adverse events reported to be more frequent in the Chantix group included angina pectoris, nonfatal myocardial infarction, need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease.

The FDA advises that patients taking Chantix should check with their doctor if they have new or worsening symptoms of heart disease, such as difficulty breathing, chest pain or pain while walking.

Shortly after Chantix first became available in the U.S. in 2006, patients began reporting negative side effects to the FDA, most notably for suicidal thoughts and actions. In 2009, the FDA required Chantix to carry a black box warning, the agency’s strongest warning, because of persistent complaints about depression, violent mood swings, vivid dreams and nightmares, and suicidal behaviors.

Source:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259469.htm

http://www.rightinginjustice.com/news/2009/07/01/fda-now-requiring-stronger-warnings-on-chantix-labels/

http://www.rightinginjustice.com/news/2011/05/31/chantix-suicides-and-violence-much-more-common-newly-found-reports-show/