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Chantix and Heart Disease

Wednesday, July 6, 2011 // Uncategorized

There is a recent article in the Canadian Journal of Medicine that was done at Johns Hopkins University that was recently reported in The New York Times linking Chantix with cardiovascular risk.  The Canadian Journal of Medicine is not one of the world’s leading medical journal and not one of the journals to which I subscribe.   It would be ironic if the treatment to end a cardiovascular risk factor actually was a cardiovscular risk factor.  There was a recent FDA warning about the use of Chantix is patients with cardiovascular risk factors.

Chantix (varenicline): Label Change – Risk of Certain Cardiovascular Adverse Events

[Posted 06/16/2011]

AUDIENCE: Family Medicine, Cardiology

ISSUE: FDA notified healthcare professionals and patients that the Prescribing Information for this drug product will be strengthened to inform the public that use of varenicline may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section and the patient Medication Guide.

BACKGROUND: FDA reviewed a randomized, double-blind, placebo-controlled clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix or placebo. While cardiovascular adverse events were infrequent overall, certain events, including heart attack, were reported more frequently in patients treated with Chantix than in patients treated with placebo. The events 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. FDA is continuing to evaluate the cardiovascular safety of Chantix and is requiring the manufacturer to conduct a large, combined analysis (meta-analysis) of randomized, placebo-controlled trials. FDA will update the public when additional information is available.

RECOMMENDATION: See the Data Summary section of the Drug Safety Communication for additional information.

Healthcare professionals should be aware that smoking is an independent and major risk factor for cardiovascular disease, and smoking cessation is of particular importance in this patient population. The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease.

Patients are encouraged to read the Medication Guide they receive along with their Chantix prescription.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1
  • Download form2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[06/16/2011 – Drug Safety Communication3 – FDA]

Previous MedWatch Alert:

[11/20/20074]

  The Times article is a meta analysis which is a compilation of a number of studies and this technique has some limitiations.  Another problem is that the patients in the different studies took Chantix for different times.  Here is the New York Times article:

July 4, 2011

Study Links Smoking Drug to Cardiovascular Problems

By DUFF WILSON

Chantix, the best-selling prescription drug for smoking cessation, was linked to an increased risk of a heart attack, stroke or other serious cardiovascular event for smokers without a history of heart disease compared with smokers who did not use the drug, according to a Canadian medical journal report released on  Monday.

The finding added to previous warnings about the pill’s connection to psychiatric problems and cardiovascular risks for people with a history of heart disease.

It posed a new challenge to a product that has been prescribed to 13 million people and had $755 million in sales last year.

Officials of Pfizer, the manufacturer of Chantix, and the Food and Drug Administration responded that they had been planning to conduct a joint analysis of clinical trials on whether Chantix posed heart risks, due next year.

“This would have raised a red flag for us if the flag hadn’t already been flying,” Dr. Celia Winchell, a team leader with the agency’s Center for Drug Evaluation and Research, said in an interview.

Pfizer, in a statement, said the analysis in the Canadian Medical Association Journal was based on too few heart or cardiovascular events to draw conclusions about the risks. The company said Chantix brought “immediate and substantial” health benefits to smokers who quit.

The senior author of the new report, Dr. Curt D. Furberg, a Wake Forest medical professor, said there were better ways to quit and called for removal of the drug from the market.

“It piles up,” he said. “I don’t see how the F.D.A. can leave Chantix on the market.”

The lead author, Dr. Sonal Singh, assistant professor of medicine at Johns Hopkins University, said the agency and Pfizer had failed to pursue signs of cardiovascular risk since Chantix was approved in 2006.

“The F.D.A. should have already put it on their warning label,” Dr. Singh said. “The risk is substantial, the risk is present in smokers without heart disease, and Pfizer knew about this for five years.”

Last month, the agency issued a safety notice about cardiovascular risk from Chantix use by people with a history of cardiovascular disease, based on a study of 700 people.

The new report is broader, analyzing 14 randomized clinical trials involving 8,200 patients, excluding those with cardiovascular disease so that it gives a better picture of which heart problems the drug could cause in otherwise healthy people trying to quit smoking.

The new study, known as a meta-analysis, compiled data from 14 random, blinded, placebo-controlled clinical trials that tracked cardiovascular outcomes. It found 52 out of 4,908 people taking Chantix had serious cardiovascular events, a rate of 1.06 percent, compared with 27 out of 3,308 people taking a placebo, a rate of 0.82 percent. While the absolute difference is only 0.24 percent, the weighted, relative difference is 72 percent.

“We have known for many years that Chantix is one of the most harmful prescription drugs on the U.S. market, based on the number of serious adverse effects reported to the F.D.A.,” Dr. Furberg said in a statement. “It causes loss of consciousness, visual disturbances, suicides, violence, depression and worsening of diabetes. To this list we now can add serious cardiovascular events.”

Dr. Furberg, who once directed clinical trials for the government and writes widely about drug safety, has been paid as an expert witness in cases against Pfizer. Dr. Singh and two other researchers said they had no conflicts of interest.

When combining studies of smokers with and without pre-existing disease, the study found that doctors could expect to get one extra cardiac event associated with Chantix for every 28 smokers they treated with the drug. The researchers also estimated one additional person would quit for every 10 treated with Chantix.

The benefit of Chantix was emphasized in a separate commentary in the journal by Dr. J. Taylor Hays of the Mayo Clinic in Rochester, Minn. He described the meta-analysis as “timely and important” but said it lacked overall size and standardization. Dr. Hays, who has been paid by Pfizer to study Chantix, said the benefits of quitting smoking outweighed the risks of the drug.

Chantix is selling well overseas. In Japan, for instance, some pharmacies ran out for a while recently, even as the drug failed to meet expectations in the United States because of health warnings and bad publicity.

I think this is of interest, but I think that Chantix is the most effective smoking cessation medicine to date.  It may be safe to use for short periods of time as is the approved indication.  I would pay attention and treat patients’ other risk factors while they are on Chantix.  It certainly can cause depression and patients should be caused about this.

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