May 24, 2001 - FDA Asked for Heart Drug WarningMay 24, 2001 - F.D.A. Panel Considers Warning Label for a Heart Medicine
A trial study conducted last year by the National Institutes of Health (NIH) found that patients who used the drug Cardura faced a 25% increase in combined cardiovascular disease events (i.e. non-fatal heart attack, stroke, coronary heart disease, and other events). The study also found that heart failures were twice as common for Cardura users compared with older drugs. The significance of those results prompted researchers to discontinue the study and notify doctors of the initial results.
According to Dr. Lawrence R. Krakoff of Mount Sinai School of Medicine, " Many physicians are unaware the drug might be dangerous . . . there must be a warning, this is a safety issue."
Cardura is among the top 50 prescribed drugs in the U.S., with worldwide sale of $800 million. In response to a citizen's committee petitioned by Salvatore Graziano, a New York lawyer representing patients who have taken Cardura, an FDA advisory committee is reviewing the NIH study.
During the FDA advisory board hearing, Pfizer, the manufacturer of Cardura, argued that the federal study linking congestive heart failure and stroke was flawed. "There is no evidence that Cardura is causally associated with the occurance of congestive heart failure, heart attacks, or stroke," said Tricia Walmsley, a Pfizer medical director.
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