Trasylol Kidney Failure Following Heart Surgery

Bayer’s problems are growing as they face thousands of potential Trasylol lawsuits following increasing reports of their heart surgery drug’s side effects. Trasylol has recently been linked to a higher risk of kidney failure, 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. Most heart surgery patients and families of patients who died following bypass surgery don’t know if they were given Trasylol during their open heart surgery. Many patients suffering from Trasylol side effects such as kidney failure or heart failure don’t know if they were given Trasylol during their surgery because the heart medication was given during the bypass procedure.

Trasylol affects the way in which blood clots. It is given to open heart surgery patients to help prevent excessive bleeding. Trasylol is mainly used during repeat coronary artery bypass (CABG) surgery to reduce the amount of bleeding both during and after surgery. Until being pulled from the market late in 2007, the drug had been in use for 13 years and a million patients had 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 side effects with an increased risk of developing heart failure, kidney failure, myocardial infarction, and stroke in bypass heart surgery patients.

On September 21, 2006 the FDA’s Cardiovascular and Renal Drug Advisory Committee met to discuss current data regarding Trasylol problems. On September 29, 2006, the FDA issued a public health advisory stating that it had new information that Bayer neglected to disclose an earlier study 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 failure, 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 number of patients affected by the drug continues to rise as the public becomes more aware of the drugs devastating side effects.

If you or a loved one has had open heart surgery and then experienced Trasylol kidney failure, heart failure or stroke, you may be able entitled to compensation. A Trasylol lawsuit attorney can help evaluate your claim.

Trasylol Lawsuits and Patient Safety

Trasylol lawsuits continue to be filed around the United States on behalf of patients suffering from kidney failure and stroke problems and families who are pursuing wrongful death claims on behalf of loved ones who died following heart surgery. The Supreme Court is set to hear the case of Wyeth v. Levine later this year. This case centers on the question of whether a patient who has been harmed by a drug can sue under state law if the drug was approved by the FDA.The potential effect of this decision cannot be underestimated. People injured by defective drugs, including people who have filed a Trasylol lawsuit, will be affected by the Supreme Court’s decision in this case.

The top doctors at the New England Journal of Medicine (NEJM) have come out and strongly stated their opinion along with 47 state attorneys general and two former FDA commissioners, David Kestrel and Donald Kennedy. The journal editors asked the justices to carefully consider how overwhelmed the FDA is and to weigh that against patient safety stating:

“The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety,” the doctors said in a brief filed Thursday. Without the discoveries dredged up by plaintiffs’ lawyers through liability litigation, “the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”

The Wyeth case involves Diana Levine, a Vermont guitarist, who was injected with Phenergan, a medication for nausea, and subsequently developed gangrene which led to the amputation of her arm. She sued the drug’s manufacturer Wyeth, arguing that the manufacturer failed to adequately warn consumers about the risks of the injections. The NEJM editors and scores of others concerned with patient safety are worried that the rights of patients are eroded in the face of preemption arguments aimed to protect drug companies. Proponents of preemption stand by their position that the FDA weighs the risks and benefits of a drug’s safety and after approval the drug manufacturer should be protected from lawsuits by consumers who were injured by the approved drug.

Bayer Pharmaceutical facing 78 Trasylol lawsuits in U.S.

COLOGNE, Germany – Bayer’s CEO stated that Bayer AG is facing 78 Trasylol lawsuits in the United States as a result of its heart surgery drug. “We are not aware of any lawsuit outside the United States,” Werner Wenning told a shareholders’ meeting.

Each year approximately one million patients undergo surgery following a heart attack. Prior to Trasylol being withdrawn from the marketplace, the majority of patients who were at increased risk of bleeding during surgery had 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.

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 November 2007, Bayer withdrew Trasylol from the marketplace following a Canadian study that associated Trasylol with an increased risk of death and kidney failure. Bayer plans on defending Trasylol claims vigorously, however time will tell how they deal with potentially thousands of claims from individuals and families throughout the country as litigation continues.

Trasylol Lawsuits Filed | Renal Failure Wrongful Death

Bayer is potentially facing thousands of Trasylol lawsuits brought on behalf of individuals and families of heart surgery patients throughout the United States. Trasylol also referred to as “Aprotinin” is a bovine pancreatic trypsin inhibitor (BPTI). Trasylol is used during heart surgery to help prevent excessive bleeding.

In November 2007, the Food and Drug Administration requested that Bayer stop marketing Trasylol until further review of a Canadian study that revealed the heart surgery drug increased the risk of death. From the FDA website:

The FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study’s researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.

An important study published in the New England Journal of Medicine in January 2006 linked Trasylol with kidney damage compared to less expensive generic medications aminocaproic acid and tranexamic acid. It is estimated that if Trasylol had been taken off the market in early 2006 following the study, 22,000 patient lives could have been saved.

For more information regarding a Trasylol lawsuit please call Fields Law Firm or e-mail us for a free confidential consultation. We are presently representing patients and families throughout the United States.

Trasylol Recall Follows Kidney Failure Problems

On November 5, 2007, the U.S. Food and Drug Administration (FDA) announced that Bayer Pharmaceuticals Corporation agreed to a “marketing suspension” of its Trasylol drug. Trasylol is a drug that was designed to control bleeding during heart surgery. Two weeks before the FDA’s announcement, researchers from the Ottawa Health Institute notified the FDA that they had stopped a study on Trasylol because it appeared to increase the risk of death for patients, compared to two other drugs used in the study.

Prior to the Trasylol recall, Dr. Dennis Mangano, a medical researcher, published a study in the New England Journal of Medicine in January 2006 that patients who had been given Trasylol had twice the rate of kidney failure and an increased risk of strokes, heart attacks and encephalopathy (a type of brain disease).

After the Trasylol recall, two studies published on February 28, 2008 in the New England Journal of Medicine confirmed that patients who were given Trasylol had an increased risk of death. The release of these studies follows an interview of Dr. Dennis Mangano on the TV show 60 Minutes. Dr. Mangano contended that the FDA should have pulled Trasylol from the market after his study was released in January 2006. It is estimated that approximately 413,000 patients received Trasylol between the time of his study and the time of the recall. According to Dr. Mangano, 22,000 lives could have been saved if the drug had been taken off the market in January 2006.

For more Trasylol news please visit our Trasylol lawsuits news and information website.

60 Minutes Trasylol Video

60 Minutes Story on Trasylol Kidney Failures and Heart Attacks

On Sunday, February 17, 2008, the CBS news show 60 Minutes, featured a story concerning the serious side effects from Bayer’s heart surgery drug called Trasylol. According to the 2006 study by medical researcher Dr. Dennis Mangano, the most serious and common complications associated with Trasylol were increased incidents of renal and kidney failure and heart attacks. His observational study included over 5000 patients around the world. When asked about his Trasylol study, Dr. Mangano told 60 Minutes’ that, “It showed an important association between Trasylol use and kidney failure requiring dialysis and it showed a trend towards increased death in hospitals in these patients.”

The 60 minutes story also profiled the Trasylol patient Joe Randone. He went in for heart valve replacement surgery at the age of 52. Following surgery where Trasylol was put in Mr. Randone’s IV, he suffered two heart attacks and kidney failure. In August 2006 Mr. Randone died from complications. The family has filed a Trasylol lawsuit against Bayer. Dr. Mangano estimated that 1000 lives per month could have been saved if the drug had been taken off the market after his Trasylol study was published.