FDA Updates Chantix Label After Study Links it to Heart Problems

U.S. regulators are warning of another possible <"http://www.yourlawyer.com/topics/overview/chantix_side_effects">Chantix side effect – heart problems in patients with pre-existing cardiovascular disease. According to a Drug Safety Communication issued by the Food & Drug Administration (FDA) today, information detailing this possible side effect will be added too the “Warnings and Precautions” section of the Chantix physician labeling.

The new warning was prompted by a study that assessed Chantix for smoking cessation in 700 patients aged 35 to 75 years with stable, documented cardiovascular disease (other than, or in addition to, hypertension). The patients received a 1 mg dose of Chantix twice per day or a placebo for 12 weeks. The treatment period was followed by a 40 week non-treatment period.

In this trial, Chantix was effective in helping patients quit smoking and remain abstinent from smoking for as long as one year, the FDA said. But while cardiovascular adverse events were infrequent overall, some were reported more frequently among Chantix patients. These included heart attack, infrequent chest pain, need for coronary revascularization, and peripheral vascular disease.

The FDA said it is continuing to evaluate the cardiovascular safety of Chantix and has directed Pfizer to conduct a large, combined analysis (meta-analysis) of previous randomized, placebo-controlled Chantix trials. The agency will update the public when additional information is available.

Chantix users have been advised to seek medical treatment if they experience new or worsening symptoms of cardiovascular disease while taking the drug, including:

• Shortness of breath or trouble breathing
• New or worsening chest pain
• New or worse pain in legs when walking

The FDA approved Chantix in 2006 as a treatment for smoking cessation. Chantix blocks nicotine by targeting the brain’s nicotine receptor. In 2009, the FDA announced that a Boxed Warning would be added to the Chantix label for serious psychiatric side effects.

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