Trasylol Should Remain on Market Says FDA Panel, Despite Risk of Kidney Failure and DeathSep 13, 2007 | Parker Waichman LLP, LLP
Drug Safety reviewers say Trasylol should remain on the market, despite being linked to an increased risk death. Yesterday, a Food & Drug Administration (FDA) advisory panel voted 16-1 to recommend that the FDA allow continued sales of Trasylol, although the experts on the panel concluded that more studies of the drug’s safety were needed.
Trasylol, marketed by Bayer AG, is used during heart bypass surgeries to prevent bleeding. The drug works by blocking enzymes that dissolve blood clots. Trasylol has been undergoing an FDA safety review since 2006 when studies linked the drug to serious side effects, including kidney failure, heart attacks and stroke. 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 at risk for significant blood loss during bypass surgeries.
The FDA decided to convene this latest advisory panel after two other studies linked Trasylol to an increased risk of death. One of those studies, 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 I3 drug report was withheld from the FDA by Bayer prior to a September 2006 advisory panel meeting on Trasylol’s safety. Bayer claims that this was an oversight, as the company’s management was not informed of the report until after the safety review.
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. The company also says that Trasylol significantly reduces the need for blood transfusions during bypass surgery. 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.
While the advisory panel did recommend that Trasylol be allowed to remain on the market, it also found that the drug merits further study. The FDA is not obligated to follow the advice of advisory panels, although in most cases it does.