FDA adds heart warning to Pfizer anti-smoking pill

Jun 16, 2011 By MATTHEW PERRONE , AP Health Writer

(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.

The said Thursday a study of 700-heart disease patients taking Chantix showed a small uptick in heart problems among those taking the drug versus those taking placebo. The agency stressed that the drug helped patients quit smoking and that this benefit "should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease."

Chantix is a twice-daily tablet that works by binding to nicotine receptors in the brain, reducing the symptoms of withdrawal.

The FDA will add new warnings to the drug's label about the study's findings. Patients will also receive an updated medication guide with their Chantix prescription that talks about the heart risks.

Drugmaker Pfizer will be required to analyze a large group of studies to further define the heart risk, according to the FDA. The company said in a statement that "the overall rates reported in the study were low."

Approved in May 2006, Chantix has been used by millions of patients in the U.S., though sales have declined since 2008 when the drug was first linked to psychological side effects, including depression and suicidal thoughts. It currently carries a boxed warning, the most serious type, about those risks. GlaxoSmithKline's competing drug, Zyban, carries the same warning.

New York-based . reported sales of $755 million for Chantix last year. Most of the drug's new sales have been driven by patients outside the U.S. Company shares dipped 5 cents to $20.14 in afternoon trading.

Explore further: Tagging drugs to fight counterfeit medicines

not rated yet
add to favorites email to friend print save as pdf

Related Stories

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.

FDA clears Eli Lilly's blood thinner Effient

Jul 10, 2009

(AP) -- The Food and Drug Administration on Friday approved a highly anticipated blood thinner from Eli Lilly, though the drug must carry the agency's sternest warning because of its bleeding risks.

Recommended for you

Use new meningitis vaccines only for outbreaks

3 hours ago

(AP)—A U.S. panel on Thursday recommended that two new meningitis vaccines only be used for rare outbreaks, resisting tearful pleas to give it routinely to teens and college students.

New antibiotic avycaz approved

7 hours ago

(HealthDay)—The combination antibiotic Avycaz (ceftazidime-avibactam) has been approved by the U.S. Food and Drug Administration to treat adults with complicated infections of the intra-abdominal area or urinary tract, ...

Tagging drugs to fight counterfeit medicines

Feb 25, 2015

The U.S. and other countries are enacting rules to clamp down on the sales of fake pharmaceuticals, which pose a public health threat. But figuring out a system to track and authenticate legitimate drugs still faces significant ...

Watchdog group seeks FDA ban of antifungal tablets

Feb 24, 2015

(AP)—A consumer safety group is calling on the Food and Drug Administration to pull certain antifungal tablets off the market, saying there are safer medicines that do not carry risks of liver damage.

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.