Trasylol, a drug used to prevent bleeding during heart bypass surgeries that has been linked to kidney failure, will face the scrutiny of a Food & Drug Administration (FDA) advisory panel for the second time since 2006. The FDA undertook its first review of Trasylol in September 2006 after two studies found that the drug doubled the risk of kidney failure for patients undergoing bypass surgery. Since that first review, two other studies have found that Trasylol could increase the risk of death.
On its website, the FDA said that the purpose advisory panel safety review scheduled for tomorrow is to “provide recommendations about the overall risk-benefit assessment for Trasylol”. The FDA said that the panel would be paying special attention to information not submitted during the 2006 Trasylol safety review. Shortly before last September’s meeting, Trasylol’s manufacturer, Bayer Pharmaceuticals, received one of the two studies linking the drug to an increased risk of death, but Bayer did not pass the information on to the advisory panel. Bayer claims that this was an oversight, as the company’s management was not informed of the report until after the safety review. The results from that study, known as the I3 drug report, suggested that Trasylol increased the risk of a patient dying by 54 percent. That study, which analyzed a database of hospital patients treated with the drug, suggested that Trasylol could also increase the likelihood of serious kidney damage, congestive heart failure and strokes. A second study published last year in the Journal of the American Medical Association also suggested that the risk of death increased by about 50 percent for some patients. During that study’s five-year examination period, 223 deaths occurred among 1072 patients treated with Trasylol.
The first Trasylol safety review resulted in changes to the drug’s label. Last December, the FDA updated the Trasylol label to include a black box warning – the agency’s strictest safety notice – stating that the drug placed patients at a high risk of kidney failure. The black box warning also cautioned that the use of Trasylol should be reserved only for patients who were risk for significant blood loss during bypass surgeries. This time around, the FDA will ask the panel about strengths and weaknesses in the latest Trasylol studies. The last two studies were observational, and did not involve clinical trials.
For its part, Bayer denies that the last two studies are evidence that Trasylol is linked to high death rates, although the company has conceded that the drug is associated with higher rates of kidney failure. Trasylol has been under fire for the past several years, in part because of the studies suggesting it is dangerous, but also because several generic drugs, specifically Amicar and Cyklokapron, have been found to be a safer choice for bypass patients, and cost just a fraction of what Bayer charges for Trasylol.