Trasylol Law Blog : Bayer Drug Trasylol Lawsuit Class Action : Trasylol Recall Lawyer Attorney

Three antifibrinolytic agents have been used in cardiac surgery to minimize bleeding and reduce the need for transfusion. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The first, Trasylol, known generically as aprotinin, is a naturally occurring serine protease inhibitor, but observational studies showing an association between aprotinin and increased rates of cardiovascular and cerebrovascular complications, renal failure, and short- and long-term mortality have raised a concern over its safety.

The alternative medications are two lysine analogues, tranexamic acid and aminocaproic acid. These drugs work by inactivating an enzyme called plasmin so it stops from breaking down blood clots which helps prevent bleeding. They have proven to be safe and effective substitutes for Trasylol and do not present the same serious side effects. They are also less costly options compared to Trasylol. The direct pharmacy cost of aprotinin for a 4-hour cardiac procedure has been reported to be more than $1,400, as compared with less than $4 for aminocaproic acid.

A May 2008 New England Journal of Medicine article comparing the three alternatives concluded that “despite the possibility of a modest reduction in the risk of massive bleeding, the strong and consistent negative mortality trend associated with aprotinin as compared with lysine analogues precludes its use in patients undergoing high-risk cardiac surgery.” Researchers have estimated that if alternative medications had been used as opposed to Trasylol, $1 billion in healthcare costs could have been saved.

We represent all Trasylol heart surgery patients and families on a contingency basis which means that there are never any legal fees unless we win compensation in your case through a settlement or through Trasylol lawsuit. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Trasylol lawyer will contact you to answer any of your questions.

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Bayer HealthCare Pharmaceuticals, Inc. has been dealing with Trasylol heart surgery lawsuits over its heart surgery drug which is also referred to as “Aprotinin”. The Trasylol lawsuits allege that Bayer is liable for manufacturing and failing to warn Trasylol users of its dangerous side effects. The Trasylol lawsuits allege that Bayer knew their drug increased patients’ risk of death, but the drug company failed to disclose its knowledge to the FDA. This is based on the Bayer study that concluded Trasylol users have a 64% higher risk of death than those who took a similar alternate drug. Bayer did not publicize this study or notify the FDA until after a January 2006 study was published in the New England Journal of Medicine.

That study concluded Trasylol use doubled kidney failure risks, increased heart attack risks by 50%, increased the risk of heart failure by 109% and increased stroke risks by 181% compared to alternative drug use. After this study, Bayer still refused to pull Trasylol off the market until what was essentially a product recall in November 2007. The author of the January 2006 study claims that if Bayer had removed the drug immediately after the study was published, approximately 431,000 patients would not have used the drug and 22,000 lives would have been saved. The fact Bayer failed to take timely action even in light of its own study calls into question whether it was putting profit over patients.

We represent all Trasylol heart surgery patients and families on a contingency basis which means that there are never any legal fees unless we win compensation in your case through a verdict or through Trasylol settlements. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Trasylol lawyer will contact you to answer any of your questions.

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A recent article in the Milwaukee Journal Sentinel covers the widespread problem of the questionable financial relationships between physicians and drug and medical device companies. More information is becoming available as open record laws bring the financial arrangement of doctors and pharmaceutical companies into public view. An example listed by the article is Dr. Richard Wolman, an anesthesiologist with the University of Wisconsin-Madison School of Medicine and Public Health.

Dr. Wolman worked as a speaker for Bayer Healthcare Pharmaceuticals. Bayer was the manufacturer of Trasylol (also known as “Aprotinin”) prior to it being pulled from the marketplace. Dr. Wolman received tens of thousands of dollars for giving talks that included information about Trasylol. Following increasing reports of the dangerous side effects of Trasylol, sales of Bayer’s heart surgery drug were suspended in November 2007. As congress continues to push for more information regarding the financial relationships between doctors and the manufacturers of devices and drugs the problem appears to be larger and involve more and more money. Many of these industry ties were never previously disclosed even though the doctors were involved with research that evaluated whether pharmaceuticals and medical devices were safe.

If you or a loved one needs help finding out if Trasylol was one of the heart surgery drugs used during the procedure we can request the medical records for you. Please call or contact us via e-mail for a free no-obligation review of your potential Trasylol lawsuit.

We are currently representing patients and families throughout the United States in bringing claims against the manufacturer. There is a limited time to file Trasylol lawsuits and we recommend that patients or family members contact an attorney to begin investigating their case.

We represent all Trasylol Bayer heart surgery patients and their families on a contingency basis which means that there are never any legal fees unless we win compensation in your case. Please contact us as soon as possible and a Trasylol lawyer will contact you to answer any of your questions.
 

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Trasylol lawsuits continue to be filed throughout the United States as the Trasylol Bayer heart surgery drug has increasingly been associated with serious side effects including kidney failure and stroke following bypass surgery. Many patients and families have questioned whether Bayer’s heart drug, also referred to as “Aprotinin”, was used during their procedure. The problem is that without reviewing the medical records from the day of surgery or a billing statement it is difficult to know. This has left many people questioning whether problems that occurred during or shortly after surgery are possibly related to Trasylol.

Trasylol (Aprotinin) in Medical Records

A patient who had bypass surgery and wants to find out whether Trasylol was used during their procedure has the right to request their medical records. Most medical providers require a written request and some have a specific form for requesting copies of records. Medical providers also have the right to charge a fee for retrieving and copying your records.

You may request another person’s medical records, however the patient must give authorization to request the records. This permission must be given through written authorization. If a patient has died following surgery and you are trying to find out if Trasylol was used a personal representative will need to request the medical records. Medical providers are very strict regarding who they will release records to in order to protect people’s privacy rights.

If you or a loved one needs help finding out if Trasylol was used during heart surgery we can request the medical records for you. Please call or contact us via e-mail for a free no-obligation review of your potential Trasylol lawsuit.

We are currently representing patients and families throughout the United States in bringing claims against the manufacturer. There is a limited time to file Trasylol lawsuits and we recommend that patients or family members contact an attorney to begin investigating their case.

We represent all Trasylol heart surgery patients and their families on a contingency basis which means that there are never any legal fees unless we win compensation in your case. Please contact us as soon as possible and a Trasylol attorney will contact you to answer any of your questions.
 

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Patients and families throughout the United States have looked at filing Trasylol recall lawsuits based on the often fatal side effects of the heart surgery drug also referred to as “Aprotinin”. Currently no class action Trasylol recall suits have been filed by Fields Law Firm and claims are being made individually.

The lawsuits claim that Bayer, the drug’s manufacturer, was negligent in several ways including:

• marketing and selling Trasylol as a safe and effective drug for heart surgery patients
• failing to adequately warn patients of unreasonable and dangerous side effects some of which were fatal
• failing to conduct adequate pre-clinical testing and post-marketing studies to determine the safety and side effects of Trasylol
• failing to use ordinary care in designing, testing and manufacturing Trasylol

We represent all Traylol recall litigation clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Trasylol lawyer will contact you to answer any of your questions.

Below is a copy of a Trasylol complaint that was filed on behalf of a patient who suffered side effects related to Trasylol.

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Information from leading worldwide cardiac centers was compiled for a study regarding the bypass surgery drug Trasylol. Kidney failure, stroke, and heart attack are side effects linked with Trasylol heart surgery patients according to the observational study published in January 2006 in the New England Journal of Medicine (NEJM).

Trasylol Kidney Damage

The NEJM study reported some startling information regarding Bayer’s drug Trasylol in a study of 4,400 heart surgery patients who received the medication:

• Trasylol raises the risk of stroke by 181 percent
• Trasylol raises the risk of heart attack by 48 percent
• Trasylol increases heart failure by 109 percent

The Food and Drug Administration (FDA), in response to the Trasylol study, issued an advisory to the medical community. The FDA alerted physicians to carefully weigh the risks and benefits of Trasylol before giving it to an open heart surgery patient.

Trasylol Kidney Failure Warnings

It is estimated that over 10,000 bypass surgery patients may be unnecessarily on kidney dialysis due to Trasylol. Heart surgery patients were administered Trasylol to reduce blood loss during bypass surgery. If you have had open heart surgery, your treating physician may have decided to give you the drug Trasylol, which has been associated with kidney and heart damage.

Kidney Failure Trasylol Side Effects

Drugs used during bypass heart surgery can have many different side effects. The following are some of the side effects that are linked to Trasylol. Kidney failure is one of the primary risks linked with the medication.

• Kidney failure
• Heart failure
• Blood clot formation
• Heart Attack
• Abnormal heart beat
• Abnormal kidney function

If you or a loved one have had open heart surgery and then experienced Trasylol kidney failure, stroke or heart failure, you may be able to file a Trasylol lawsuit. A Trasylol attorney can help you evaluate your claim. We are currently representing patients and families throughout the United States.

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An article published on February 21, 2008 in The New England Journal of Medicine provides more evidence of the increased risk of death in patients receiving Trasylol (Aprotinin) during heart surgery. Researchers at Duke University reviewed a database containing information on over 10,000 patients who received either Trasylol, aminocaproic acid or no drug therapy during coronary-artery bypass grafting (CABG) heart surgery.

They concluded that the patients who received Trasylol had an increased risk of death and kidney failure compared to those who were given aminocapric acid or no drug therapy. This Trasylol study follows on the heels of the Canadian study known as BART which compared two alternative drugs, Tranexamic acid (Cyklokapron) and Aminocaproic acid (Amicar).

During this study patients were randomly given one of the drugs. The finding included a much great rate of death in the patients who received Trasylol compared to the two other drugs. Most of the Trasylol related deaths were from cardiac complications with one in 50 patients dying who received Aprotinin during heart surgery. After the BART study was published Bayer removed the remaining stock of their controversial drug due to the Trasylol side effects that were confirmed by the study.

Prior to being withdrawn from the market in November 2007, Trasylol had been widely used since its approval by the Food and Drug Administration in 1993. Aprotinin is used as a medication administered by injection to help reduce bleeding during heart surgery. The drug works by slowing down fibrinolysis, a process that leads to the breakdown of blood clots.

For more information regarding Trasylol claims 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. We have additional information available at our national Trasylol recall lawsuits website.
 

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Following reports linking Bayer’s bypass surgery drug to an increased risk of Trasylol Stroke, heart attack and kidney failure the manufacturer suspended marketing the drug in late 2007. However Trasylol continued to be used until as late as May 2008 when Bayer then started removing the remaining stock from the marketplace in the United States. Trasylol is also referred to by its generic name “Aprotinin”. The FDA announced what was essentially a Trasylol recall on November 5, 2007.

Studies have shown that patients given Trasylol have an 181 percent greater risk of suffering a stroke compared to patients who were given either of the generic medications Cyklokapron (tranexamic acid) or Amicar (aminocaproic acid). Trasylol was approved by the Food and Drug Administration in 1993 to help prevent excessive bleeding in patients undergoing bypass heart surgery. Worldwide the drug has been given to over one million patients. In one of the largest observational Trasylol studies headed by Dr. Dennis Mangano, researchers found a much greater incidence of serious side effects such as kidney failure, stroke and heart attack in patients who received Trasylol during their surgery.

In another study conducted in Canada referred to as “BART”, Trasylol was compared to the alternative generic heart surgery drugs and it was found that 1 in 50 patients who received Trasylol died from complications linked to the drug. Given the increased risks and high cost of Trasylol compared to the generic alternatives doctors began questioning whether it should be administered to patients before it was pulled from the market.

A Trasylol attorney at Fields Law Firm is available to answer any questions you may have regarding how to find out if the drug was used during heart surgery. We will also request copies of your medical records or family member’s records at no cost to you in order to help find out if Trasylol was used. We are currently filing lawsuits for individuals and families affected by Trasylol in all 50 states.
 

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Bayer’s Trasylol heart surgery drug was withdrawn from the market late in 2007. More patients and families have been coming forward and filing Trasylol lawsuits as they learn that the drug was used during their bypass surgery. Trasylol, also referred to as “Aprotinin”, has a long history.

• Trasylol (Aprotinin) is a naturally occurring protein obtained from bovine lung. It consists of 58 amino acid residues.
• Aprotinin was discovered in the 1930’s by Kraut and coworkers when they isolated a kallikrein inhibitor from bovine lung.
• It was launched as Trasylol in Germany in 1959.
• It is administered intravenously to help reduce excessive perioperative blood loss and the need for blood transfusion during bypass heart surgery (CABG).
• It is supplied as a clear, colorless, sterile isotonic solution when administered intravenously.
• It has been concluded that Aprotinin reduces perioperative bleeding by acting as an antifibrinolytic, however the mechanism by which it functions is not understood.
• Trasylol was approved by the FDA in 1993.
• According to Bayer, 4.3 million patients have received Trasylol since being approved.

We are filing Trasylol lawsuits for patients and families in all 50 states. Free, confidential no-obligation consultation regarding how to find out if Trasylol was used during heart surgery and your legal options.
 

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