New York Times, "FDA Says Bayer Failed to Reveal Trasylol Drug Risk Study"

          Bayer A.G., the German pharmaceutical giant, failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke, the Food and Drug Administration announced Friday. Bayer scientists even appeared at a public meeting called by the F.D.A. on Sept. 21 to discuss the possibility that the drug, Trasylol, might have serious risks. But they did not mention the study or its worrisome results.
          In a highly unusual move, the food and drug agency released a public health advisory saying it had learned of the study’s existence only on Wednesday. Preliminary results of the study demonstrate “that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes,” the advisory said.
          Nevertheless, the agency did not change its advice about whether patients should be given the drug. Instead, it restated previous warnings that Trasylol’s use should be limited to patients in whom the risks of blood loss outweighed the drug’s risks.