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.

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.

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.

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.

kidney failure

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 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.

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.

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 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.

The following video describes hemodialysis that many patients suffering from Trasylol kidney problems have to undergo three times per week following their heart surgery.

When Your Kidneys Fail

Healthy kidneys clean your blood by removing excess fluid, minerals, and wastes. They also make hormones that keep your bones strong and your blood healthy. When your kidneys fail, harmful wastes build up in your body, your blood pressure may rise, and your body may retain excess fluid and not make enough red blood cells. When this happens, you need treatment to replace the work of your failed kidneys.

How Hemodialysis Works

In hemodialysis, your blood is allowed to flow, a few ounces at a time, through a special filter that removes wastes and extra fluids. The clean blood is then returned to your body. Removing the harmful wastes and extra salt and fluids helps control your blood pressure and keep the proper balance of chemicals like potassium and sodium in your body.

One of the biggest adjustments you must make when you start hemodialysis treatments is following a strict schedule. Most patients go to a clinic-a dialysis center-three times a week for 3 to 5 or more hours each visit. For example, you may be on a Monday-Wednesday-Friday schedule or a Tuesday-Thursday-Saturday schedule. You may be asked to choose a morning, afternoon, or evening shift, depending on availability and capacity at the dialysis unit. Your dialysis center will explain your options for scheduling regular treatments.

Researchers are exploring whether shorter daily sessions, or longer sessions performed overnight while the patient sleeps, are more effective in removing wastes. Newer dialysis machines make these alternatives more practical with home dialysis. But the Federal Government has not yet established a policy to pay for more than three hemodialysis sessions a week.

Hemodialysis.

Several centers around the country teach people how to perform their own hemodialysis treatments at home. A family member or friend who will be your helper must also take the training, which usually takes at least 4 to 6 weeks. Home dialysis gives you more flexibility in your dialysis schedule. With home hemodialysis, the time for each session and the number of sessions per week may vary, but you must maintain a regular schedule by giving yourself dialysis treatments as often as you would receive them in a dialysis unit.

Adjusting to Changes

Even in the best situations, adjusting to the effects of kidney failure and the time you spend on dialysis can be difficult. Aside from the “lost time,” you may have less energy. You may need to make changes in your work or home life, giving up some activities and responsibilities. Keeping the same schedule you kept when your kidneys were working can be very difficult now that your kidneys have failed. Accepting this new reality can be very hard on you and your family. A counselor or social worker can answer your questions and help you cope.

Many patients feel depressed when starting dialysis, or after several months of treatment. If you feel depressed, you should talk with your social worker, nurse, or doctor because this is a common problem that can often be treated effectively.

Getting Your Vascular Access Ready

Arteriovenous fistula. One important step before starting hemodialysis is preparing a vascular access, a site on your body from which your blood is removed and returned. A vascular access should be prepared weeks or months before you start dialysis. It will allow easier and more efficient removal and replacement of your blood with fewer complications. For more information about the different kinds of vascular accesses and how to care for them, see the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) fact sheet Vascular Access for Hemodialysis.

Equipment and Procedures

When you first visit a hemodialysis center, it may seem like a complicated mix of machines and people. But once you learn how the procedure works and become familiar with the equipment, you’ll be more comfortable.

 
Graft.

Dialysis Machine

The dialysis machine is about the size of a dishwasher. This machine has three main jobs:

• pump blood and watch flow for safety
• clean wastes from blood
• watch your blood pressure and the rate of fluid removal from your body

Dialyzer

Structure of a typical hollow fiber dialyzer. The dialyzer is a large canister containing thousands of small fibers through which your blood is passed. Dialysis solution, the cleansing fluid, is pumped around these fibers. The fibers allow wastes and extra fluids to pass from your blood into the solution, which carries them away. The dialyzer is sometimes called an artificial kidney.

• Reuse. Your dialysis center may use the same dialyzer more than once for your treatments. Reuse is considered safe as long as the dialyzer is cleaned before each use. The dialyzer is tested each time to make sure it’s still working, and it should never be used for anyone but you. Before each session, you should be sure that the dialyzer is labeled with your name and check to see that it has been cleaned, disinfected, and tested.

Dialysis Solution

Dialysis solution, also known as dialysate, is the fluid in the dialyzer that helps remove wastes and extra fluid from your blood. It contains chemicals that make it act like a sponge. Your doctor will give you a specific dialysis solution for your treatments. This formula can be adjusted based on how well you handle the treatments and on your blood tests.

Needles

Many people find the needle sticks to be one of the hardest parts of hemodialysis treatments. Most people, however, report getting used to them after a few sessions. If you find the needle insertion painful, an anesthetic cream or spray can be applied to the skin. The cream or spray will numb your skin briefly so you won’t feel the needle.

Most dialysis centers use two needles-one to carry blood to the dialyzer and one to return the cleaned blood to your body. Some specialized needles are designed with two openings for two-way flow of blood, but these needles are less efficient and require longer sessions. Needles for high-flux or high-efficiency dialysis need to be a little larger than those used with regular dialyzers.

Arterial and venous needles.

Some people prefer to insert their own needles. You’ll need training on inserting needles properly to prevent infection and protect your vascular access. You may also learn a “ladder” strategy for needle placement in which you “climb” up the entire length of the access session by session so that you don’t weaken an area with a grouping of needle sticks. A different approach is the “buttonhole” strategy in which you use a limited number of sites but insert the needle back into the same hole made by the previous needle stick. Whether you insert your own needles or not, you should know these techniques to better care for your access.

NIH Publication No. 07-4666
December 2006

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.