Pfizer anti-smoking drug has heart risks: US

Jun 16, 2011

US regulators said Thursday that the label on Pfizer's anti-smoking drug Chantix must be changed to warn of a slightly higher risk of heart problems in patients who already have cardiovascular disease.

The drug, also known as varenicline, was shown in a clinical trial of 700 smokers to be associated with an elevated risk of heart attack, angina, and in some patients when compared to a placebo.

"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," the said.

FDA has ordered the drug-maker to "conduct a large, combined analysis (meta-analysis) of randomized, placebo-controlled trials" and will update the public once that is complete.

Earlier this year, some 1,200 plaintiffs in the United States who claim Chantix causes depression or filed lawsuits against Pfizer.

The drug is approved in almost 90 countries around the world and used by some seven million Americans.

If Chantix is found to be dangerous it could be withdrawn from the US market, where sales have suffered since alleged links to depression and suicide mushroomed last year.

Explore further: FDA warns doctors to beware fake drug distributors

add to favorites email to friend print save as pdf

Related Stories

FDA adds heart warning to Pfizer anti-smoking pill

Jun 16, 2011

(AP) -- Federal health regulators are warning doctors and patients that Pfizer's anti-smoking drug Chantix may slightly increase the risk of heart attack and other cardiovascular problems.

FDA: New warning needed for Chantix

Feb 03, 2008

The U.S. Food and Drug Administration Friday called for increased awareness of the health risks of the smoking cessation drug varenicline.

FDA requires Chantix, Zyban to have warning

Jul 01, 2009

(AP) -- The Food and Drug Administration will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency's strongest safety warning over side effects including depression and suicidal thoughts.

Recommended for you

Discount generic drug programs grow over time

Sep 22, 2014

Generic discount drug programs (GDDPs, which charge nominal fees to fill prescriptions) have grown over time and their initial lower use by racial/ethnic minorities has evaporated, writes author Song Hee Hong, Ph.D., of the ...

Seniors successfully withdraw from meds

Sep 19, 2014

Elderly people have proved receptive to being de-prescribed medications, as part of a trial aimed at assessing the feasibility of withdrawal of medications among older people.

User comments : 0