Bayer 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 surgery . However, a controversy mounting around continued use of Trasylol, and in February 2006, the FDA issued a public health practitioners warning advisory to limit use of Trasylol. Side effects heart surgery increasingly have been reported in patients.
On September 21, 2006, the FDA met to investigate the dangers of Trasylol. Although Bayer appeared to cooperate with this investigation FDA, Bayer was withholding data from a study which indicated Trasylol causes side effects life threatening. FDA learned that Bayer did not disclose this damaging data shortly after the FDA completed the investigation. However, the FDA learned about this only because a scientist from Bayer evacuated from the FDA study. Bayer did not disclose voluntarily given FDA even when representatives of Bayer 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. Data
Harmful Bayer study indicated that Trasylol increases the risk of death, stroke, congestive heart failure, and kidney failure a patient. This data was comparable to an earlier study that indicated the administration of Trasylol during surgery dramatically increases the risk of life-threatening complications and death of a patient. This previous study showed the use of Trasylol during surgery outcomes at an increased risk of 181% stroke or encephalopathy, a risk 55% higher heart attack or heart failure, and a 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 drugs are generics that are cheaper options, and more importantly, does not present the same dangers threatening the lives of patients. Since these generics are available, require the continued use of Trasylol substantial and unnecessary risks on patients. Because of these risks, some scientists have concluded that Trasylol should not be used in patients with cardiac surgery.
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 approximately 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 healthcare costs each year. In addition, replacement of Trasylol with the generic available will save $ 250 million in health care costs every year because Trasylol costs of $ 1.300 per dose, while the two available generic replacements cost $ 11 per dose and $ 44 per dose.
Following references were relied on to write the above article: Dennis T. Mangano
, Ph.D., MD, et al, risk associated with aprotinin in cardiac surgery, New England Journal of Medicine 2006; 354: 353-65. William R. Hiatt
, MD, observational studies of drug safety and lack of transparency Aprotinin, New England Journal of Medicine 2006; 355: 2171-73.
Jerry Avorn, MD, Dangerous Deception Hiding evidence of adverse effects to drugs, the New England Journal of Medicine 2006; 355: 2169-71.
Gardiner Harris, FDA says Bayer failed to reveal drug risk study, The New York Times, September 30, 2006.
Food and Drug Administration, Public Health Advisory: Aprotinin injection (marketed as Trasylol) updated 9/29/2006
Charles W. Hogue, MD & Martin J. London, MD, Aprotinin use during cardiac surgery: A new or continuing controversy? Anesthesia and analgesia 2006; 103: 1067-1070.
Food and Drug Administration release; December 30, 1993
Category: Healthcare Basics