Last month, Bayer scientists met with the Food and Drug Administration (FDA) to discuss their heart-surgery drug, Trasylol, and its possible risks. But Bayer failed to mention that they already conducted a large study on the drug and the results showed an increase in the risk of death and stroke.
The study performed by Bayer evaluated 67,000 patient records. Of those, 30,000 received Trasylol and the rest got a different drug. The patients who received Trasylol had a greater risk of kidney failure, heart attack and stroke. A researcher involved in it alerted the FDA about the drug’s side-effects.
The FDA is evaluating the new study to find out whether the results will change the agency’s advice on the drug. Trasylol is given to patients prior to surgery to reduce the risk of blood loss and the need for transfusions in patients undergoing heart bypass surgery.