An analysis of clinical trials found the anti-smoking drug Chantix, manufactured by Pfizer Inc., produced a higher rate of heart attacks and strokes in patients who used the treatment compared to those who didn’t.
An FDA warning says it’s “more likely that (the increased risk) is related to the drug and not purely a chance finding.”
Of 4,190 Chantix users, Bloomberg reports, 13 were found to have experienced a major cardiovascular event such as heart attack or stroke. That compares with six of 2,812 who took a placebo in 15 Pfizer- sponsored clinical trials.
Chantix already carries a warning that it raises the risks of suicide and may be tied to higher heart danger in patients with cardiovascular disease.
Last year after citing the heart concerns, regulators asked Pfizer to include the warnings about Chantix and to further evaluate the risks by conducting a large analysis of existing studies of the drug. The FDA’s warning about heart attacks and strokes followed that analysis.
According to the Bloomberg story, patients taking Chantix should contact their doctor if they experience new or worsening symptoms of cardiovascular disease, such as chest pain, shortness of breath, calf pain or sudden onset of weakness, numbness or difficulty speaking.
The drug generated $720 million in sales last year for Pfizer, and the FDA said about 2.3 million Chantix prescriptions were dispensed in the year ended in September.
Pfizer is currently facing a lawsuit in federal court, based on claims that Chantix caused psychiatric disorders leading a man being placed in a mental hospital.
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