Trasylol Lawyer & Attorney : Fields Law Firm : Trasylol Injury, Kidney & Heart Failure

In March 2008 the New England Journal of Medicine published an editorial – Learning from Aprotinin – Mandatory Trials of Comparative Efficacy and Safety Needed. They concluded the problems that have surfaced regarding Trasylol are going to be repeated in other drugs unless the FDA institutes changes in the requirements of postmarketing studies and restrictions on drug distribution and use. The magnitude of Trasylol side effects and the potentially fatal consequences that have affected tens of thousands of heart surgery patients are becoming more and more apparent.

Trasylol (aprotinin) was first approved by the FDA in 1993 to help in reducing blood loss during bypass surgery. It is estimated that by 2006, around 200,000 heart surgery patients had been prescribed aprotinin. Dr. Dennis Mangano and a group of researchers raised a red flag in 2006 and 2007 regarding the safety of Trasylol. Dr. Mangano published an observational study that showed Trasylol increased the risks of kidney failure, heart attack, stroke and death. The New England Journal of Medicine, in their editorial, asked the important question “What can we learn from the saga of aprotinin, a drug that apparently confers less overall benefit than cheaper alternatives yet has remained on the market for more than 14 years and become the recommended hemostatic agent for high-risk cardiac surgeries?”

A vital piece of the drug approval and monitoring process that is missing, according to the editorial, is the requirement for more information on infrequent but serious complication and performance relative to alternative drugs. They state that the key lesson to be learned from the current Trasylol problems is that there needs to be head-to-head comparative trials when a new drug has alternatives. This needs to be done before a drug such as Trasylol is routinely administered for a large number of patients. Furthermore, they state that we cannot rely on the drug manufacturers to perform these studies on a voluntary basis because it is not in their commercial or financial interest to do so.

For more information please visit our Trasylol class action lawsuit center.

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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 you have had heart surgery, but are unsure whether you were given Trasylol, please contact a Trasylol attorney for more information on obtaining your medical records.

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 http://www.fda.gov/cder/drug/advisory/aprotinin.htm).

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 http://www.fda.gov/bbs/topics/NEWS/NEW00453.html).

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Bayer's Trasylol problems are growing following increasing reports of the drug's side effects. Trasylol has recently been linked to a higher risk of kidney damage, heart attack, and death in the five years following a patient undergoing bypass heart surgery. In 1993 Trasylol (Aprotinin) was approved by the Federal Drug Administration. Aprotinin is manufactured by Bayer under the brand name Trasylol. Over the past several years Trasylol sales continued to increase even though studies indicated serious Trasylol kidney damage side effects.

Most heart surgery patients don't know if they were given Trasylol during their open heart surgery. Many patients suffering from Trasylol kidney damage side effects don't know if they were given Trasylol during their surgery because the surgeon made the decision whether to administer the drug to stop excessive bleeding during surgery.

Trasylol affects the way in which blood clots. It is given to open heart surgery patients to prevent excessive bleeding side effects. Trasylol is mainly used during repeat coronary artery bypass surgery to reduce the amount of bleeding both during and after surgery. The drug has been in use for 13 years and a million patients have received it. One of the most serious complications for bypass surgery patients is excessive bleeding. Clotting medications such as Trasylol reduce the amount of blood transfusion needed during surgery. In 2006 The New England Journal of Medicine (NEJM) published a study that reported Trasylol problems with an increased risk of developing heart failure, kidney damage, myocardial infarction, and stroke in bypass heart surgery patients.

On September 21, 2006 the FDA's Cardiovascular and Renal Drug Advisory Committee met to evaluate current data regarding Trasylol side effects. On September 29, 2006, the FDA issued a public health advisory stating that it had new information that Bayer failed to disclose an earlier study that it had conducted involving 67,000 heart surgery patients. Preliminary review of this study suggested that Trasylol side effects included higher risks for stroke, congestive heart failure, kidney damage, and death. Bayer failed to disclose this study during the Advisory Committee on September 21, 2006.

Dr. Dennis Mangano, the lead author of the NEJM Trasylol side effects study, has noted that Trasylol problems occurred more frequently than those linked with the drug Vioxx. Dr. Mangano relates, "In fact our findings raise even more troubling concerns, for:
(1) aprotinin has been on the market for three times as long as Vioxx, yet few comprehensive safety studies have been conducted since approval;
(2) the life-threatening complications with aprotinin found here occurred far more frequently than those with Vioxx; and
(3) far less expensive generic alternatives to aprotinin which are equally effective in limiting bleeding have been available, but have been underused."

The observational study concluded, "Our findings raise serious concerns regarding the safety of an approved drug intended to limit blood loss in at-risk patients undergoing surgery." Mangano related his opinion regarding the ongoing use of Trasylol, stating "In good conscience, I could not administer (Trasylol) to this group of patients, especially given the availability of safer alternatives." Trasylol problems continue to be studied and the FDA is monitoring Trasylol kidney damage side effects and advising physicians to consider limiting the drug's use.

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A recent study based on observations at 69 leading cardiac centers around the world was published regarding Bayer Pharmaceutical’s heart surgery drug Trasylol. Kidney failure, heart failure, and stroke are side effects associated with Trasylol heart surgery patients according to the study published by Mangano et al. in January 2006 in the New England Journal of Medicine (NEJM).

Each year approximately one million patients undergo surgery following a heart attack. The majority of patients who are at increased risk of bleeding during surgery have the option of one of three antifibrinolytic drugs to limit blood loss: Trasylol (Aprotinin), Amicar (aminocaproic acid), or Cyklokapron (tranexamic acid). These drugs work by inactivating an enzyme called plasmin so it stops from breaking down blood clots which helps prevent bleeding.

The observational study published in the (NEJM) raised significant concerns regarding the safety of Trasylol. The study revealed that Trasylol doubled the risk of kidney failure along with other serious side effects including stroke and heart attack. Trasylol has been on the market for use in cardiac surgery since its approval in 1993. It is estimated that as many as 10,000 patients may be on kidney dialysis due to Trasylol. Kidney failure was not associated with the less costly generic drugs aminocaproic acid and tranexamic acid according to the study.

The FDA has approved revised labeling for Trasylol following a review of safety information. On September 21, 2006, the FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety of Trasylol. The Trasylol labeling changes are based upon the recommendations of that advisory committee. The new label states that Trasylol should only be administered to patients who are at an increased risk for blood loss during heart surgery. The label changes include a warning that Trasylol increases the risk for kidney damage. The costs associated with patients suffering from Trasylol kidney failure are significant. Average annual dialysis costs per patients are over $66,000.

Dialysis is a type of renal replacement therapy which acts as an artificial kidney for patients who have lost kidney function due to renal failure. There are two primary types of kidney dialysis treatment: hemodialysis and peritoneal dialysis. The overwhelming majority of dialysis patients receive hemodialysis where the blood is circulated outside the body through a hemodialyzer, cleaned and then returned to the patient. Hemodialysis treatments are typically performed three times per week, with each session lasting 3 to 5 hours. Dialysis involves substantial cost, whether it is hemodialysis or peritoneal dialysis.

On September 29, 2006, the FDA announced that Bayer had informed the agency of an additional Trasylol study. The result of the study suggests that in addition to serious kidney damage, Trasylol may also increase the risk of death, strokes, and congestive heart failure. It is estimated that the replacement of Trasylol with the generic drug aminocaproic acid would prevent kidney failure and related dialysis treatment in 11,050 patients per year saving more than $1 billion per year. Replacement of Trasylol with the generic drug tranexamic acid would prevent 9790 renal complications requiring dialysis each year with similar annual savings.

Trasylol kidney failure is a serious side effect that requires further study and may result in additional labeling changes. Mangano et al., in their January 26, 2006 study, suggest that given the serious risk of kidney damage and other side effects continued Trasylol use is not recommended due to the availability of less expensive generic drugs that are not associated with serious cerebrovascular events and renal dysfunction.

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