Trasylol Heart Surgery Side Effects

Bayer’s Trasylol heart surgery side effects have recently been linked to an increased rate of kidney failure, heart attack, and death in the five years following a patient undergoing heart surgery.

In 1993, Trasylol (generically known as “aprotinin”) received FDA approval for use in certain cardiac surgeries. Trasylol is still used today to reduce the amount of blood a patient loses both during and after a surgery. However, a mounting controversy surrounds the continued use of Trasylol, and in February of 2006, the FDA issued a public health advisory warning physicians to limit use of Trasylol.

On September 21, 2006, the FDA met to investigate the dangers of Trasylol. Although Bayer appeared to cooperate with this FDA investigation, Bayer was withholding data from a study which indicated Trasylol causes life-threatening side-effects. The FDA learned that Bayer did not disclose this damaging data shortly after the FDA completed its investigation. However, the FDA learned about this data only because a scientist from Bayer’s study tipped off the FDA. Bayer did not willingly disclose the data to the FDA even when Bayer representatives were face to face with FDA officials to discuss the dangers of Trasylol, and even though numerous FDA officials commented to Bayer that they needed more data.

The damaging data from Bayer’s study indicated that Trasylol increases a patient’s risks of death, stroke, congestive heart failure, and kidney failure. This data was comparable to an earlier study that indicated the administration of Trasylol during surgery dramatically increases a patient’s risks of life-threatening complications and death. This earlier study showed Trasylol use during surgery results in a 181% increased risk of stroke or encephalopathy, a 55% increased risk of heart attack or heart failure, and an over 200% increased risk of kidney failure.

On top of this dramatic inflation of life-threatening risks, Trasylol may actually be less effective than other drugs that were available before Trasylol. These alternative drugs are generics that are cheaper, and more importantly do not pose the same life-threatening dangers to patients. Since these generics are readily available, the continued use of Trasylol imposes substantial and unnecessary risks on patients. Because of these risks, some scientists have concluded that Trasylol should not be used in cardiac surgery patients anymore.

If doctors listen to these scientists and replace Trasylol with available generics, they will help prevent kidney failure in patients following heart surgery. Currently, it is estimated that around 10,000 patients may be unnecessarily on kidney dialysis due to Trasylol use. The resulting reduction in the need for kidney dialysis will save over $1 billion in health care costs every year. Furthermore, replacement of Trasylol with the available generics will save $250 million in health care costs every year because Trasylol costs $1,300 per dose, while the two available generic replacements cost $11 per dose and $44 per dose.



The following references were relied on to write the above article:

Dennis T. Mangano, Ph.D., M.D., et al, The Risk Associated with Aprotinin in Cardiac Surgery, New England Journal of Medicine 2006; 354:353-65.

William R. Hiatt, M.D., Observational Studies of Drug Safety — Aprotinin and the Absence of Transparency, New England Journal of Medicine 2006; 355:2171-73.

Jerry Avorn, M.D., Dangerous Deception — Hiding the Evidence of Adverse Drug Effects, New England Journal of Medicine 2006; 355:2169-71.

Gardiner Harris, FDA says Bayer failed to reveal drug risk study, The New York Times, Sept. 30, 2006.

Food and Drug Administration, Public Health Advisory: aprotinin injection (marketed as Trasylol), updated September 29, 2006 (accessed Dec. 10, 2006, at ).

Charles W. Hogue, M.D. & Martin J. London, M.D., Aprotinin Use During Cardiac Surgery: A New or Continuing Controversy?, Anesthesia and Analgesia 2006; 103:1067-70.

Food and Drug Administration release; Dec. 30, 1993 (accessed Dec. 10, 2006, at ).