(Updates with Pfizer comment in fifth paragraph, closing share price in seventh paragraph.)
June 16 (Bloomberg) -- Pfizer Inc.’s smoking cessation aid Chantix, already carrying a warning it raises risks of suicide, may be tied to higher heart danger in patients with cardiovascular disease, U.S. regulators said.
The Food and Drug Administration found infrequent chest pain, heart attacks and other adverse reactions in a study of 700 people with cardiovascular disease, the agency said today in a statement. The information will be added to the warnings and precautions section of the prescribing information for Chantix.
The FDA is requiring New York-based Pfizer, the world’s biggest drugmaker, to further evaluate the heart risks with an analysis of existing studies. Chantix, approved in 2006, generated $755 million in sales last year. The revenue has fallen since the FDA warned in 2009 that the medicine may increase the chance of suicide or erratic behavior.
“The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease,” the FDA said in its statement.
“The overall cardiovascular event rates reported in the study were low,” Pfizer said in an e-mailed statement.
The company plans to discuss the analysis of existing studies and the product labeling with FDA.
Pfizer rose 5 cents to $20.24 at 4 p.m. in New York Stock Exchange composite trading.
Chantix affects dopamine, a chemical in the brain involved in controlling mood and behavior. Because dopamine triggers a positive mood response, regulating its levels can remove some of the pleasure derived from smoking.
--With assistance from Robert Langreth in New York. Editors: Steve Walsh, Bruce Rule
To contact the reporters on this story: Catherine Larkin in Washington at firstname.lastname@example.org; Anna Edney in Washington at email@example.com.
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