In its latest notification the FDA has said that the smoking cessation drug, Chantix is linked with higher occurrence of major cardiovascular events like cardiovascular related death, nonfatal stroke and non fatal heart attack. With this notification the FDA is informing the public about the results of a large, combined analysis (called a meta-analysis) of clinical trials that compared patients who received the smoking cessation drug Chantix (varenicline) to patients who received a placebo (an inactive treatment) and the increased risk was not statistically significant, which means it is uncertain whether the excess risk for the Chantix group was due to the drug or due to chance.

Chantix is a prescription medicine used to help adults quit smoking that works by blocking the effects of nicotine on the brain. FDA first notified the public about a possible increased risk of cardiovascular adverse events with Chantix in its June 2011 Drug Safety Communication (DSC). FDA required the manufacturer of Chantix to conduct the meta-analysis to further evaluate the cardiovascular safety of the drug, and believes it is important to let health care professionals and patients know about the results of this study. The meta-analysis findings of cardiovascular risk are similar to the findings in the smoking cessation clinical trial of patients with stable cardiovascular disease that was described in FDA’s June 16, 2011 DSC. The Warnings and Precautions section of the Chantix label has been updated to include the results of the meta-analysis.

With this notification the federal agency is advising health care professionals to weigh the risks against the benefits of Chantix. It is important to note that smoking is a major risk factor for cardiovascular disease, and Chantix is effective in helping patients to quit smoking and abstain from it for as long as one year. The health benefits of quitting smoking are immediate and substantial.

What is Chantix

Chantix (varenicline) is a smoking cessation medicine. It is used together with behavior modification and counseling support to help you stop smoking. Chantix works in the brain to block the pleasurable effects of smoking. This helps to decrease your desire to keep smoking.

Chantix Side effects

  • Chest pain or pressure
  • Tight feeling in your neck or jaw, pain spreading to your arm or shoulder,
  • Vomiting
  • Sweating
  • General ill feeling
  • Feeling light-headed or short of breath
  • Sudden numbness or weakness, especially on one side of the body
  • Sudden severe headache, confusion, problems with vision, speech, or balance
  • Easy bruising, unusual bleeding, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds
  • Fever, sore throat, and headache with a severe blistering, peeling, and red skin rash
  • Or the first sign of any blistering type of skin rash, no matter how mild.
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