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FDA Drug Safety Podcast: Chantix may increase cardiovascular risk in certain patients

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On June 16, 2011 the Food and Drug Administration issued a drug safety communication informing the public that the prescription smoking cessation aid Chantix may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.

I am Yolanda Fultz-Morris from F-D-A’s Center for Drug Evaluation and Research.


FDA reviewed a clinical trial of smokers with cardiovascular disease who were treated with Chantix or a placebo. Cardiovascular adverse events were infrequent overall, however, certain events, including heart attack, were reported more frequently in patients treated with Chantix than in patients treated with a placebo.

FDA recommends that those taking Chantix should:

  • Be aware that Chantix may increase the risk of certain cardiovascular adverse events in those with cardiovascular disease.
  • Be aware that smoking is a major risk factor for cardiovascular disease and taking Chantix may help you quit smoking.
  • Weigh the known benefits of Chantix against its potential risks when deciding to use the drug, especially smokers with cardiovascular disease.
  • Seek medical attention if you experience new or worsening symptoms of cardiovascular disease while taking Chantix.
  • Read the Medication Guide that comes with the Chantix prescription.

Safety information will be added to the warnings and precautions section of the Chantix physician labeling. The patient Medication Guide will also be revised to inform patients about the possible risk of cardiovascular adverse events.

FDA is continuing to evaluate the cardiovascular safety of Chantix. FDA is requiring the manufacturer, Pfizer, to conduct a detailed analysis of clinical trial testing that has been done on Chantix. FDA will update the public when additional information is available.

FDA urges healthcare providers and patients to report any adverse events or side effects that may be associated with the use of Chantix to FDA’s MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot GOV slash M-E-D-W-A-T-C-H.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash D-R-U-G-S.



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