FDA calls for more testing for Pfizer's stop-smoking drug Chantix
The Food and Drug Administration is requiring New York-based Pfizer, the world's largest research-based pharmaceutical company, to perform more evaluation of the heart risks with of its drug Chantix. The prescription Chantix already carries a warning label that it can raise risks of suicide, but the FDA has found that Chantix may be tied to higher heart risks in patients with cardiovascular disease. In a study of 700 people with cardiovascular disease, U.S. regulators found infrequent chest pain, heart attacks and other adverse reactions to the drug.
Chantix, approved in 2006, had $755 million in sales last year. In 2009, the FDA warned that the medicine may increase the chance of suicide or erratic behavior.
Pfizer has faced hundreds of lawsuits alleging that the drug can lead to suicide attempts. Lawsuits against Pfizer include claims that Pfizer was negligent in its design, testing, and promotion of Chantrix.
Chantix side effects and warnings have long been known. In 2008, the FDA issued a public health advisory that some Chantix users developed serious psychiatric symptoms, and that some had committed suicide. In the same year, the Federal Aviation Administration stopped permitting its pilots to use the drug Chantix, referencing that potential side effects could pose a threat to the safe operation of aircraft.
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