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 Side Effects | Trasylol Litigation News

An increasing number of studies have suggested Trasylol is a potentially dangerous drug and an expensive one. The cost per dose of Trasylol is $1,300. The generic drug Amicar is $11 per dose and the generic Cyklokapron is $44 per dose. According to the studies, neither of the generic drugs has been associated with an increased risk of kidney failure, heart attack or stroke. The 2006 Mangano study found that Trasylol was linked to an increased risk of serious side effects including myocardial infarction (48%), heart failure (109%), and stroke (181%).

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 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 Causing Kidney Failure After Heart Surgery | Trasylol Medical Records

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

Trasylol in Medical Records
A patient who had heart surgery and suspects that 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 permission to access 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.

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.