Trasylol Timeline
1930—Aprotinin (also known as “kallikrein inactivator”) is first extracted from cow parotid glands.
1936—Aprotinin is extracted from cow pancreas.
1953—Aprotinin is applied clinically for the treatment of pancreatitis.
1959—Drug is launched as Trasylol in Germany.
1963–2003—124 cases of aprotinin-induced anaphylaxis (severe allergic reaction) are reported in 61 publications. Eleven patients died.
1964—Aprotinin is extracted from cow lung.
1971–1973—The therapeutic effect of Trasylol in the treatment of traumatic shock is investigated in a large German study. It is proven to be effective when applied within 30 minutes.
1987—Aprotinin is first used in Europe to prevent blood loss during cardiac surgery. In subsequent years, its use is extended to other forms of major surgery (liver, vascular, spinal surgery and transplantation).
1987—Researchers conduct the first of 64 randomized, controlled studies on the use of aprotinin in heart surgery, proving that it does help to minimize bleeding.
1993—Food and Drug Administration approves Trasylol for the reduction of bleeding in heart surgery patients. Miles Inc. (later purchased by Bayer) would market Trasylol and conduct further studies to evaluate its use in other surgeries with high risk of bleeding.
1996—Ischemic Research and Education Foundation, led by Dr. Dennis T. Mangano, begins collecting and analyzing data on Trasylol.
August 1997—Trasylol’s label is changed to reflect the FDA’s concerns over patients’ hypersensitivity to getting the drug.
1998—Study sponsored by Bayer suggests that Trasylol increases risk of blood clotting, thus leading to heart attacks. Company dismisses results as reflecting extraneous issues.
2004—Bayer concedes that patients receiving Trasylol repeatedly are at a greater risk of anaphylaxis.
2005—Bayer’s sales of Trasylol reach $275 million.
2005—About 150,000 Americans are given Trasylol during surgery.
January 26, 2006—IREF announces the results of a study with 4,300 patients at 69 institutions worldwide. Published in the New England Journal of Medicine, it concludes that Trasylol increases the risk of serious adverse events and death.
January 26, 2006—Study by Dr. Keyvan Karkouti et al., published in online medical journal Transfusion, suggests that Trasylol increases the risk for renal dysfunction or failure.
February 8, 2006—FDA issues a public health advisory, saying it is conducting a safety evaluation of Trasylol.
July 2006—FDA issues a second public health advisory on Trasylol, in response to two studies. The agency urges doctors to use the drug only in critical situations, where reduced blood loss is essential.
September 21, 2006—FDA holds a meeting of the Cardiovascular and Renal Drugs Advisory Committee to assess the risks and benefits of Trasylol.
September 27, 2006—After a whistleblower alerts the FDA, Bayer confirms the existence of a contracted study involving 67,000 patients. Findings appear to show that Trasylol patients are more likely to suffer kidney failure, heart failure, stroke and death than patients using other treatment.
October 2, 2006—FDA reprimands Bayer for having withheld data from the CRDAC. The company conceded, but insists the results are preliminary.
October 3, 2006—FDA issues yet another public health advisory urging physicians to use Trasylol judiciously.
October 29, 2006—FDA issues a warning that Trasylol may have serious kidney and cardiovascular toxicity.