The U.S. Food and Drug Administration on Wednesday said it is evaluating the safety of Bayer AG's Trasylol drug after studies linked it to higher risks of kidney problems, heart attacks and strokes in patients who undergo artery bypass graft surgery, Reuters reported. The drug is used to prevent blood loss during surgery, said the FDA, which issued a public health advisory to doctors and patients. "We're working to evaluate the potential risks and determine whether there is a need for further action," Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research, said in a statement. "In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients." The FDA said it plans to hold an advisory committee meeting later this year to discuss existing data on the benefits and risks of the drug as well as to determine if more safety measures are needed. Researchers reported last month in the New England Journal of Medicine that the drug doubled the risk of kidney failure and stroke and increased the chance of heart failure or heart attack by 55 percent. German-based Bayer last month said that the results were "not consistent with the more than 15 years of clinical data and experience Bayer has amassed on this drug." A company spokesman in Germany said Bayer will cooperate with the FDA and other regulators. "We're analyzing the data we have on the drug," he said.
