The AP (6/17, Perrone) reports, "Federal health regulators are warning doctors and patients that Pfizer's anti-smoking drug Chantix [varenicline] may slightly increase the risk of heart attack and other cardiovascular problems." On Thursday, the FDA "said...a study of 700-heart disease patients taking Chantix showed a small uptick in heart problems among those taking the smoking-cessation drug versus those taking placebo." The agency "will add new warnings to the drug's label about the study's findings."
Bloomberg News (6/17, Larkin, Edney) reports that the agency will also require "Pfizer...to further evaluate the heart risks with an analysis of existing studies."
Reuters (6/17) reports that in a statement, the agency said, "The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease."
The Los Angeles Times (6/16, Cevallos) "Booster Shots" blog pointed out that "heart problems aren't the only warning associated with Chantix. In 2009 the FDA warned that the drug might increase the risk of suicidal thoughts and behaviors." Also covering the story were Dow Jones Newswire (6/17, Dooren, Subscription Publication), AFP (6/17), HeartWire (6/16, O'Riordan), MedPage Today (6/16, Peck), HealthDay (6/16), and WebMD (6/16, Mann).
POSTED BY STEVEN ALMANY, MD