A recent study found that patients that received Bayer’s Trasylol during heart surgery were significantly more likely to die within the next decade. Another study of 78,000 patients, originally withheld by Bayer, found a 78 percent increased risk of death within a week following the surgery. In November Bayer suspended sales of Trasylol after a Canadian trial linked the drug to higher death rates. The FDA approved Trasylol in 1993 to help reduce bleeding during open-heart surgery and by 2005 had become “part of the fabric of cardiac surgery,” but a 2006 study linked the drug to higher rates of heart attack, stroke, kidney failure and death sparking widespread concern.
Indeed, the lives of 22,000 people could have been saved if the FDA removed Bayer’s Trasylol two years ago, when the study revealed a growing number of deaths linked to the heart drug, according to the researcher who conducted the study.
Bayer challenged the findings from the most recent studies claiming that the data analysis was flawed. Two panels of experts have advised the FDA to keep the drug on the market citing inconclusive evidence. Trasylol is still available through a restricted access program.
“The data have to be reviewed and seen in the light of all the evidence. The bottom line is there are still more people dying using this drug. FDA is the agency that has all the evidence together at this point, and they need to make an informed decision.”
It is not clear when a decision will be made about the future of Trasylol, but the FDA is in the process of reviewing the data.
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