After a study showed that the heart surgery drug Trasylol increases death rates, the pharmaceutical company Bayer pulled the drug.
The study was the latest in a series of worrisome signs that Trasylol could be dangerous. Last year, a study published in The New England Journal of Medicine found that the drug increased the risks of kidney failure, heart attack and stroke. That research concluded that halting the drug’s use would prevent 10,000 to 11,000 cases of kidney failure a year and save more than $1 billion a year in dialysis costs.
Bayer has also sponsored a study of Trasylol suggesting that the drug increased the risks of death and stroke.
The company had failed to disclose the results of its study to the agency or the advisory panel. Indeed, Bayer scientists had defended Trasylol at the panel’s hearing but had not mentioned their own study or its worrisome findings. A company investigation later concluded that the findings had been withheld as a result of “regrettable human error.”
For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.