On November 5, 2007, the FDA requested Bayer Pharmaceuticals Corp suspend the marketing of the anti-bleeding drug Trasylol pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death. The study at the Ottawa Health Institute was stopped because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study. This recall and study followed the release of a January 2006 study published in the New England Journal of Medicine that linked the drug to a higher risk of kidney failure, heart attack, stroke and even death. Unfortunately, an estimated 4.8 million cardiac patients had already received the drug since it was first introduced in 1993.

FDA investigations followed and it was eventually revealed that Bayer failed to disclose an internal study that also uncovered these dangers. The study was conducted by i3, a global pharmaceutical services company, and demonstrated that use of Trasylol may increase the chance of death, serious kidney damage, congestive heart failure, and stroke compared to other drugs. Bayer acknowledged that it did not inform the FDA about the study, which examined 78,199 patients treated between April 2003 and March 2006, indicating that it was both a mistake to withhold it and that they had done so because it was preliminary in nature and raised significant questions on the study population, outcomes, and methodology. This disclosure prompted the FDA to approve label changes in December 2006 that informed physicians and patients about the associated risks and to limit approved usage to specific situations. Ultimately, however, the FDA announced a recall.

We represent all Aprotinin 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 attorney will contact you to answer any of your questions.

Another study reveals an increased risk of serious Trasylol side effects leading to a higher mortality rate in aprotinin bypass patients. A recent study published in The New England Journal of Medicine on February 21, 2008 shows an increased risk of death for patients receiving aprotinin (Trasylol) during coronary-artery bypass grafting (CABG). The researchers analyzed hospital data from over 33,000 heart surgery patients who received Trasylol and around 45,000 patients who received aminocaproic acid.

The study examined hospital records with operating room charges that included billing for either Trasylol (33517 patients) or aminocaproic acid (44,682 patients). In patients receiving Aprotinin during their bypass surgery there was a 64% increased risk of death. The researchers concluded that doctors should weigh the benefits of Trasylol with the increased risk of death considering aprotinin showed little or not benefit in reducing the number of blood transfusions compared to the alternative drug aminocaproic acid. The researchers have provided the study data to the FDA and the manufacturer (Bayer); however Bayer has disagreed with the methods and conclusions of the study.

Study: Aprotinin during Coronary-Artery Bypass Grafting and Risk of Death
N Engl J Med 2008;358:771-83

If you or a loved one has had open heart surgery and then experienced Trasylol side effects including kidney failure, heart failure or stroke, you may be able entitled to compensation. A Trasylol class action lawsuit attorney can help evaluate your claim. For a free, confidential no-obligation consultation contact us via e-mail or by calling our toll free number 1-888-343-5375.

Excessive bleeding during cardiac surgery involving cardiopulmonary bypass is caused by blood clots dissolving faster than normal. Certain drugs that act against the breakdown of clots are called antifibrinolytic agents. Aprotinin (Trasylol), Amicar, and Cyklokapron are drugs that are used to stop severe blood loss through increasing clot formation. Fibrin, a type of protein, is the main building component of a blood clot, providing a type of scaffolding for the clot to form. Fibrinolyisis is the process the body uses to break down blood clots. Antifibrinolytic agents inhibit fibrinolyis, thereby preventing severe bleeding in heart surgery patients.

Prior to Trasylol being removed from the marketplace physicians had been advised to consider limiting the use of Trasylol considering the much less expensive and safer alternative bypass surgery drugs. Trasylol heart surgery patients who have already undergone surgery are encouraged to seek follow-up care in order to monitor any possible Trasylol side effects such as kidney damage, heart failure or stroke.

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.

Trasylol heart surgery medication has come under increased scrutiny since the Trasylol recall in November 2007. It was reviewed in several studies that showed an increase risk of life threatening side effects such as kidney failure, heart attack, stroke and complications leading to death. The number of Trasylol lawsuits filed throughout the United States is increasing as the public becomes more aware of Trasylol problems such as renal failure and strokes.

Even though Trasylol sales and marketing was suspended in November 2007 patients were still given this dangerous medication. The FDA worked with Bayer to phase Trasylol out of the marketplace in an attempt to prevent shortages of other drugs used to prevent excessive bleeding during cardiac surgery. This phase-out however, led to the continued use of Trasylol during bypass surgeries until May 2008.

A Trasylol lawyer 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.

Trasylol is an antifibrinolytic drug which helps slow down the breakdown of blood clots and prevent excessive bleeding during open heart surgery. Trasylol came under increased scrutiny following a Canadian study that showed the drug increased the risk for death compared to the generic alternatives.

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

Dr. Mangano’s 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 drug is no longer being used during heart surgery.

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. For a free, confidential no-obligation consultation contact us via e-mail or by calling our toll free number 1-888-343-5375.

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.

Looking at the hospital records associated with the surgery is the best place to find out whether Trasylol was used. Alternatively, you can also look at the hospital billing statement to see if Trasylol (also referred to as “Aprotinin”) is listed under the charges. Under federal law called the “HIPAA Privacy Rule” you have the right to see and receive a copy of your medical records. Typically after requesting your medical records you should receive them within 30 days of the time of request.

Common Questions:

Q: Is there a charge for requesting my medical records?

A: The hospital or medical provider is able under the law to charge a fee for retrieving and copying the requested medical records. Because of this, it is important to initially request only a limited number of surgery records to help lessen the charges associated with the request. In some situations the records can number into several hundred or thousands of pages depending on the specific circumstances. This can translate into a retrieval and copying bill of several hundred to over a thousand dollars since many medical providers charge one or more dollars per page of medical records.

Q: Can I request the medical records on behalf of a family member or friend?

A: Generally, you are only able to request your own medical records. Someone trying to get copies of their medical records is able to grant another person permission to request their records, however his must be done in writing or in certain circumstances a legal guardian must be appointed by the court.

Q: Am I able to request the medical records of a person who has died?

A: Typically, the person who is able to request the medical records of a person who is deceased is the personal representative of the deceased who has been designated by a will or a court has appointed the person. The key to requesting medical records of a person that has died is to include documentation along with request showing you are entitled to access the medical records.

It is a good idea to have the records reviewed by someone who can correctly interpret the records and if there is any doubt contact a medical professional or attorney who can help you in requesting and reviewing the appropriate records.

An attorney at Fields Law Firm is available to answer any questions you may have regarding how to find out if Trasylol 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.

The BART study was stopped after a planned periodic data analysis indicated reduced bleeding but also an increase in all-cause mortality for patients in the aprotinin (Trasylol) treatment arm compared to patients who received either of the generic drugs aminocaproic acid or tranexamic acid. Bayer is waiting until more information becomes available following their final data analysis before they take further action regarding Trasylol.

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 money damages. A Trasylol lawsuit attorney can help evaluate your claim.

The study revealed that patients receiving the drug had double the risk of Trasylol kidney problems along with other side effects. It is estimated that as many as 10,000 patients may be on kidney dialysis due to Trasylol. Many patients have suffered from renal failure which can often lead to death. After Trasylol enters the body during bypass surgery it is attracted to the kidneys where, as in many patients, it causes kidney problems including kidney failure. The following video describes the anatomy of the kidneys.

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

The FDA first approved Trasylol (aprotinin) in 1993 to help prevent excessive 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?”

According to the editorial, a crucial piece of the drug approval and monitoring process that is missing is the requirement for more information on infrequent but serious complications and performance relative to alternative drugs. In their opinion, the major 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.

If you or a loved on has suffered from Trasylol kidney failure side effects or has died following heart surgery where Trasylol was used please contact our Trasylol attorneys for a free consultation or help finding out if Trasylol was used during surgery.