Trasylol Lawsuit News | Aprotinin Heart Surgery Drugs Renal Failure

Bayer HealthCare Pharmaceuticals, Inc. has been facing an increasing number of patients who have filed a Trasylol lawsuit over its Aprotinin heart surgery drug. The 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 Trasylol increases patients’ risk of death, but the drug company failed to disclose its knowledge to the FDA.

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.

Surgery Trasylol Law Suit News | Trasylol Lawyer

Until recently, Bayer’s anti-bleeding drug was used on a regular basis during heart surgery. Trasylol (Aprotinin) is widely used to decrease bleeding risk during coronary artery bypass graft (CABG) surgery. There are some common side effects that persist or become bothersome following use, including: constipation, diarrhea, difficulty urinating, infection (fever, chills, sore throat), lightheadedness, sleeplessness and/or vomiting. However, more severe Trasylol side effects may result. These include: severe allergic reactions (rash, hives, or swelling of mouth, face, lips or tongue), chest pain, decreased urination, fast or irregular heartbeat, severe stomach pain, sudden severe headache, numbness of an arm or leg, vision or speech changes or confusion.

If you have questions regarding whether this heart surgery drug was used please contact a Trasylol lawyer at Fields Law Firm and we can help you find out if it was used. There is no charge for us to help you investigate if the drug was administered during the procedure.

More specifically, a January 26, 2006, report in The New England Journal of Medicine indicates that Trasylol has been shown to cause adverse and even fatal side effects by significantly increasing the risk of a heart attack, stroke, kidney failure, and heart failure. This study, conducted by Dr. Dennis T. Mangano of the Ischemia Research and Education Foundation, sampled 4,374 heart surgery patients, and revealed that more patients receiving Trasylol experienced these side effects than patients receiving either no medications or other medications intended to decrease blood loss.

The study showed that Trasylol increased the risk of stroke by 181%, doubled the risk of kidney failure, increased the risk of encephalopathy (disease or disorder of the brain) and increased risk of heart attack by 50%. It supported the use of alternative options to avoid these side effects, such as aminocaproic acid and tranexamic acid.

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 that the drug Trasylol was being removed from the marketplace.

We represent all Trasylol law suit 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.

Aprotinin Drug Trasylol | Class Action Lawsuit

Trasylol Aprotinin Side Effects Study

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.

Class Action Trasylol Updates | Heart Surgery Drug

Trasylol Heart Surgery Drug Information

What is aprotinin injection?

APROTININ (Trasylol) is a drug that affects the way blood clots. It was given to heart surgery patients during bypass procedures. Aprotinin was mainly used during repeat coronary artery bypass surgery to reduce the amount of bleeding before and after surgery. Trasylol and other clotting medications help to reduce the amount of blood transfusion required.

Trasylol

Generic Name: Aprotinin
Brand Name: Trasylol
Drug Maker: Bayer

What is it used for?

Trasylol was used during open heart surgery to help prevent blood loss and the need for blood transfusion in patients who have an increased risk of excessive bleeding during and after the operation.

How does Trasylol work?

Trasylol injection/infusion contains the active ingredient – aprotinin. Aprotinin is also available without a brand name as it is the generic drug.

Aprotinin is a type of medicine that called an antifibrinolytic. Aprotinin prevents bleeding and functions by inactivating plasmin, a substance in the blood, and thereby prevents bleeding.

Plasmin is an enzyme that is produced in the blood to break down fibrin, a major component of blood clots. Aprotinin inactivates plasmin and stops it from breaking down blood clots. This helps to prevent excessive bleeding.

Prior to the Trasylol recall, Bayer’s heart surgery drug was used to prevent excessive, life-threatening blood loss and the need for blood transfusion during open heart surgery (most often by-pass surgery) in people who are at increased risk of bleeding).

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 Lawsuit News | Trasylol Recall

Patients and families nationwide have looked at filing a Trasylol lawsuit based on the often fatal side effects of the drug Trasylol. Currently no Trasylol class action 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

Trasylol Recall

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 (also referred to as “aprotinin”) received FDA approval for use in certain types of heart surgeries. Until recently, Trasylol was used to reduce the amount of blood a patient loses both during and after a surgery. However, a mounting controversy surrounded the continued use of Trasylol, and in February of 2006, the FDA issued a public health advisory warning physicians to limit use of Trasylol.

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).

On September 21, 2006, the FDA met to investigate the dangers of Trasylol. Although Bayer appeared to cooperate with this FDA investigation, it was later learned that Bayer was withholding data from a study which revealed Trasylol causes serious and potentially deadly side-effects. The FDA learned that Bayer did not disclose this important 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 failed to willingly disclose the data to the FDA even when Bayer representatives met with FDA officials to go over the dangers of Trasylol, and even though numerous FDA officials commented to Bayer that they needed more data. Following increasing studies showing the serious risks of Trasylol, Bayer finally removed Trasylol from the marketplace in November 2007 which was essentially a Trasylol recall.

Most heart surgery patients don’t know if they were given Trasylol during their open heart surgery. Many patients suffering from Trasylol kidney failure 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 Heart Surgery Kidney Failure Lawsuit

Bayer’s widely used Trasylol heart surgery drug was subject to a recall in 2007 following a study that raised safety concerns. Prior to the recall, Trasylol (also referred to as Aprotinin) was used to help prevent excessive bleeding during open heart surgery. The study reported that Bayer’s heart surgery medication increased the risk of dying the five years following surgery by almost 50 percent.Alternative and cheaper medications used to prevent bleeding did not raise the risk of death significantly. Prior to Trasylol being withdrawn from the market late in 2007, the drug had been used for 13 years and a million patients had received it.

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.