One of the biggest questions people have when they or a family member have suffered side effects such as kidney failure, stroke or a heart attack following open heart surgery is how to find out whether or not Trasylol was used during the surgery. Patients who underwent bypass surgery most often do not know what medications were used during the surgery because their surgeon made the decision of whether to use Trasylol based on the risk of excessive blood loss during the procedure.

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. Another person is able to grant another person permission to request their medical 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.

For more information please visit our Trasylol lawsuits information website.
 

• Print
• Comments
• Trackbacks

As more Trasylol lawsuits are filed there is increasing pressure to revisit individuals right to hold companies accountable when they market a dangerous product. On the same day of a House Oversight hearing the New England Journal of Medicine (NEJM) published the results of a Canadian study that showed Trasylol (Aprotinin) increased the risk of death in patients by 50 percent. Previous studies had associated Trasylol with kidney failure, heart attacks and stroke.

On May 14, 2008 Gegory Curman, the executive editor of the NEJM testified regarding safety issues with drugs following their approval. Henry Waxman, D-CA, the House Government Reform and Oversight Committee Chair gave the opening statements. 

TESTIMONY
House Committee on Oversight and Investigations
Wednesday, May 14, 2008
Preemption – Drugs and Medical Devices
My name is Gregory Curfman, and I am the executive editor of the New England Journal of Medicine. I am here today along with my colleague, Dr. Stephen Morrissey, the managing editor, to provide testimony from our Journal. We will make the case that preemption of common-law tort actions against drug and medical device companies is ill advised and will result in less safe medical products for the American people.

The New England Journal of Medicine is nearly 200 years old. Our mission is to publish important advances in medical research, including research on new drugs and medical devices. During my 23 years at the New England Journal of Medicine, I and my colleagues have published many articles on new drugs. Some of these drugs have succeeded, but others have failed, in most cases owing to problems with safety.

We have learned over the years that approval of a new drug by the FDA by no means guarantees its safety. It is not uncommon for drugs to be approved by the FDA without long-term studies of their safety. Indeed, FDA approval of a drug is just one milestone along a path to the assessment of long-term safety. It is essential that a drug’s safety continue to be carefully monitored during the post-marketing period, because we know that serious safety issues may come to light only after a drug has entered the market. I will give three specific examples that I have encountered in my work at the New England Journal of Medicine.

The first is rofecoxib, or Vioxx, a COX-2 inhibitor used to treat arthritis pain, which was approved by the FDA in 1998. In 2000, we published in the New England Journal of Medicine a clinical trial called the VIGOR study, which showed that Vioxx effectively relieved pain while causing less gastrointestinal bleeding than traditional nonsteroidal painkillers.

However, something that the Journal editors learned later was disturbing. What was not adequately conveyed in that article was the fact that for each episode of serious gastrointestinal bleeding prevented by the use of Vioxx, one heart attack, stroke, or other serious cardiovascular problem was caused by Vioxx. There was a one-to-one trade-off, but the authors of the article, two of whom were employees of the manufacturer of Vioxx, left most of those data out, and therefore the Journal’s readers and the public were not fully informed about this serious problem.

The FDA was provided with the missing data after the article was submitted, but it was not until 2002 that the label for Vioxx was revised to reflect these cardiovascular risks; and it was not until 2004, six years after the drug was approved by the FDA and after millions of people had taken it, that it was finally removed from the market, in part owing to the mounting threat of product-liability litigation.

Example 2 is rosiglitazone, or Avandia, which was approved by the FDA in 1999 for the treatment of type 2 diabetes. It was approved solely on the basis of its ability to lower blood sugar. Whether it would make a difference to patients with diabetes by reducing the risk of cardiovascular disease, the major complication of type 2 diabetes, was unknown, because long-term clinical trials to study cardiovascular end points had not been done.

It came as a surprise when, in 2007, researchers from the Cleveland Clinic reported in the New England Journal of Medicine that, on the basis of a meta-analysis of data from multiple studies, Avandia appeared to be associated with an increased risk of cardiovascular events, not a decrease. This was a worrisome finding for fragile type 2 diabetics.

Even more surprising, was the revelation that the manufacturer of Avandia had commissioned a similar study in 2005 that showed the same result. To meet legal requirements arising from a lawsuit in New York, the company placed the results of that study on a section of its Web site, but those results were never publicized and never published in a medical journal. Today, nine years after FDA approval, Avandia remains on the market, but in November 2007 a warning about potential cardiovascular risks was added to its label, and its use has declined substantially. Last month the FDA sent a warning letter to the manufacturer for failure to submit reports on a large number of studies on Avandia to the FDA, as required by law.

The third example involves a drug called aprotinin--the brand name is Trasylol--which was approved by the FDA in 1993 and is used to control bleeding in patients undergoing cardiac surgery. In January 2006 a study in the New England Journal of Medicine suggested that the use of Trasylol was associated with an increase in heart attack, stroke, kidney failure, and death.

Later in 2006 the FDA held an advisory committee meeting to reexamine the safety of Trasylol. Shortly after the meeting, FDA officials were stunned to learn that the manufacturer had commissioned a similar study, which confirmed the findings in the New England Journal article, but had withheld the results from the advisory committee.

Tonight at 5:00 p.m., we will publish on the New England Journal of Medicine Web site a large clinical trial that shows definitively that Trasylol, as compared with other drugs used to control bleeding, results in higher mortality in patients undergoing high-risk heart surgery. The editorial accompanying the article states that, after 15 years, in all likelihood this is the end of the story for Trasylol.

What do we learn from these examples?

1. Together, these three drugs have placed millions of Americans and other people around the world at substantial risk. But patients who have been harmed by a drug have had the right to seek legal redress. Preemption would erase that right.
2. Serious adverse drug effects may not become apparent until after drugs are granted FDA approval, sometimes long after approval.
3. FDA approval by no means guarantees the safety of drugs.
4. The Congress’s FDA reform efforts in 2007 made it clear that approval is usually based on short-term efficacy studies, not long-term safety studies.
5. Manufacturers may not immediately make public information indicating safety problems with their drugs.
6. Despite the usually admirable work of the FDA, the agency is hampered by lack of resources in addressing drug safety concerns and may be slow in resolving them.

If drug and medical device companies are shielded against common-law tort actions by preemption, what will be the effect on the safety of our drugs and devices? The answer is intuitively obvious. We recently wrote in an editorial in the New England Journal of Medicine that the safety of drugs and devices in our country will almost certainly be diminished. If drug and device companies are immunized against product-liability suits, companies will surely focus less attention on the safety of their products. The possibility of litigation serves as a strong inducement for companies to be especially diligent in scrutinizing their products for safety problems. It is questionable that the purported benefit of making drugs and devices available more quickly should outweigh the possibility of redress when safety flaws are discovered later.

Patients injured by unsafe drugs and devices should not be stripped of their right to seek redress through due process of law. Preemption will undermine the confidence that doctors and patients have in the safety of drugs and devices and will have a chilling effect on the doctor-patient relationship, which has traditionally been built on trust.

Mr. Chairman and members of the Committee, we urge you and your colleagues to pass legislation that will unambiguously eliminate the possibility of preemption of common-law tort actions for drugs and medical devices. Removing this patient right would not only be unjust, but will also result in less safe drugs and medical devices for the American people.

Thank you, Mr. Chairman.

For more information on help finding out if Trasylol was used during heart surgery or information regarding Trasylol claims please visit our Trasylol lawsuit center.

 

• Print
• Comments
• Trackbacks

As the results of more studies are published, the evidence is continuing to show the problem of Trasylol kidney failure following heart surgery. Patients and families around the country are filing Trasylol lawsuits as the public becomes more aware of Bayer’s heart surgery drug side effects. Trasylol has recently been linked to a higher risk of kidney damage, heart attack, and death in the five years following a patient undergoing bypass heart surgery.

In 2006 The New England Journal of Medicine (NEJM) published a study that reported Trasylol problems with an increased risk of developing heart failure, kidney damage, myocardial infarction, and stroke in bypass heart surgery patients. This study was followed by an increasing number of Trasylol studies that confirmed the findings of the 2006 NEJM study.

Trasylol studies increasingly show that the drug causes serious problems in bypass patients. In 1993 Trasylol, also referred to as “Aprotinin”, was approved by the Federal Drug Administration (FDA). Aprotinin is manufactured by Bayer under the brand name Trasylol. Over the past several years Trasylol sales continued to increase even though studies indicated serious Trasylol kidney damage side effects until late in 2007 when Bayer finally withdrew their heart surgery drug from the market.

Most bypass heart surgery patients are unsure if they were given Trasylol during their open surgery. Many patients suffering from Trasylol kidney failure or stroke side effects don't know if they were given Trasylol during their surgery because the surgeon made the decision whether to use the drug to help prevent excessive bleed loss during surgery.

Trasylol affects the way in which blood clots. It is given to open heart surgery patients to help prevent excessive bleeding. One of the most serious complications for bypass surgery patients is excessive bleeding. Clotting medications such as Trasylol reduced the amount of blood transfusion needed during surgery. Trasylol is primarily used during repeat coronary artery bypass surgery to reduce the amount of bleeding both during and after surgery. The drug had been in use for 13 years and a million patients had received it before Bayer withdrew it from the market after growing evidence of serious side effects.

For the latest information and litigation news please visit our Trasylol lawsuit website.

• Print
• Comments
• Trackbacks

Patients and families across the United States have filed Trasylol lawsuits based on the devastating side effects of the drug. Currently no Trasylol class action suits have been filed and claims are being filed individually. The lawsuits claim that Bayer, the drug’s manufacturer, was negligent in multiple ways including:

• marketing and selling Trasylol as a safe and effective medication 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

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.

Most heart surgery patients don't know if they were given Trasylol during their open heart surgery. Many patients suffering from Trasylol kidney damage 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.

For more information please visit our Trasylol lawsuit center.

• Print
• Comments
• Trackbacks

Given the growing number of reported problems involving Trasylol kidney failure and strokes and the increasing lawsuits filed by Trasylol victims throughout the United States it is interesting to look at the drug industry’s latest voluntary marketing guidelines that are expected to be announced this week.

The Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors is expected to announce a new marketing code this Thursday. This voluntary guideline written by the industry’s trade association (PhRMA) will ask the chief executives of large drug manufacturers to provide written certification that “they have policies and procedures in place to foster compliance with the code.”

The new marketing code will presumably ban pharmaceutical marketing campaigns that in the past have provided doctors with gifts such as mugs, pens and pads. The code requires drug companies to set annual limits on the amounts they pay doctors for educational lectures. However, the industry code fails to define any limits on money spent on speaking and consulting arrangement between the drug makers and doctors throughout the country. Furthermore, these new guidelines do not apply to biotechnology or medical device companies.

PhRMA Chairman and Chairman and CEO of Merck & Co., Inc., Richard Clark, stated “Informative, ethical and professional relationships between healthcare providers and America’s pharmaceutical research companies are instrumental to effective patient care”.

Among its changes, the revised Code:

- Prohibits distribution of non-educational items (such as pens, mugs and other "reminder" objects typically adorned with a company or product logo) to healthcare providers and their staff. The Code acknowledges that such items, even though of minimal value, "may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues."

- Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals' offices in conjunction with informational presentations. The Code also reaffirms and strengthens previous statements that companies should not provide any entertainment or recreational benefits to healthcare professionals.

- Includes new provisions that require companies to ensure that their representatives are sufficiently trained about applicable laws, regulations and industry codes of practice -- including this Code -- that govern interactions with healthcare professionals. Companies are also asked to assess their representatives periodically and to take appropriate action if they fail to comply with relevant standards of conduct.

- Provides that each company will state its intentions to abide by the Code and that company CEOs and Compliance Officers will certify each year that they have processes in place to comply, a process patterned after the concept of Sarbanes-Oxley compliance mechanisms. Companies also are encouraged to get external verification periodically that they have processes in place to foster compliance with the Code. PhRMA will post on its Web site a list of all companies that announce their pledge to follow the Code, contact information for company compliance officers, and information about the companies' annual certifications of compliance.

For more information on Trasylol lawsuits and Trasylol medical and legal news please visit Trasylollawsuitcenter.com.

• Print
• Comments
• Trackbacks

Trasylol, an expensive medication given to heart surgery bypass patients during their surgical procedure to help prevent excessive bleeding may have caused staggering numbers of heart failure, kidney failure and strokes. Patients undergoing cardiac surgery were unaware that Trasylol, a medication manufactured by Bayer, has been found in clinical studies to lead to greater risk of death, stroke, and acute kidney failure.

If a patient was found by their surgeon to be at risk of excessive bleeding during surgery the patient had no way of knowing Trasylol had been found to be not only dangerous but extremely expensive compared to the generic alternatives.


Trasylol Bypass Surgery Alternative Drugs Available


A New England Journal of Medicine study reported that two other generic medications were available that are safer and less expensive than Trasylol.
Heart surgery medications that help prevent excessive bleeding during surgery:

• Trasylol cost per dose is $1,300
• The generic aminocaproic acid cost per dose is $11
• The generic tranexamic acid cost per dose is $44

The generic heart surgery drugs were revealed to be far less costly with no increased risk of heart attack, stroke or kidney failure.


For more information, please visit our Trasylol class action lawsuit website.

• Print
• Comments
• Trackbacks

Trasylol lawsuits have been filed throughout the United States alleging that the heart surgery drug is a defective medication. They state that Trasylol (aprotinin) has caused kidney failure, heart attacks and strokes. These aprotinin lawsuits claim that Bayer, the drug’s manufacturer, marketed and sold Trasylol as a safe and effective medication to help prevent excessive bleeding during bypass surgery. They also claim that Bayer failed to adequately warn patients of its side effects.

Bayer disputes the growing number of aprotinin studies that show increased risk of serious complications and death in Trasylol recipients. The causal link between Trasylol and these potentially fatal side effects has been known for several years and there is evidence that Bayer has known about the link between Trasylol and kidney failure as far back as the early 1980's. The German scientist Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found severe incidents of kidney damage in animals that were given Trasylol more than 20 years ago. According to Dr. Fischer, he was surprised Bayer wasn’t interested in his findings.

For a free consultation and help finding out if you or a loved one was given Trasylol during their heart surgery please visit our Trasylol Lawsuit Center.

• Print
• Comments
• Trackbacks

Following the Trasylol study Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) published in the May 14, 2008online issue of The New England Journal of Medicine study, Bayer decided to remove the remaining supplies of Trasylol from hospitals. This is the latest in a growing number of studies showing the dangers of Trasylol. In November 2007, Bayer agreed to suspend marketing their heart surgery drug Trasylol (aprotinin) after preliminary results from a Canadian study that revealed an increased risk of death for patients given Trasylol during bypass surgery.

Trasylol has been used by patients throughout the world during heart bypass surgery to reduce bleeding. Trasylol is an expensive drug costing $1200 to $1500 compared to cheaper and safer alternative drugs which cost around $150. The BART study was merely the latest study that have shown evidence of Trasylol increasing the risk of serious side effects like kidney failure, stroke and death. For more information please visit our Trasylol Lawsuit Center.

• Print
• Comments
• Trackbacks

Another study reveals an increased risk of significant Trasylol side effects leading to a higher mortality rate in aprotinin recipients. 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 looked at hospital records with operating-room charges that included charges for either Trasylol (33517 patients) or aminocaproic acid (44,682 patients). Patients In patients receiving Trasylol during their heart surgery there was a 64% increased risk of death. The researchers concluded that physicians 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

For more information regarding a free consultation please visit our Trasylol Lawsuit Center.

• Print
• Comments
• Trackbacks

On February 8, 2008, the American Journal of Nephrology published a study of aprotinin and kidney failure. Aprotinin is marketed as “Trasylol” by the drug company Bayer. This is the first aprotinin study to evaluate the effect of the drug on urinary NGAL (neutrophil gelatinase-associated lipocalin). Urinary NGAL increases dramatically following kidney damage.

In this observational study 369 patients undergoing heart surgery were either given aprotinin or aminocraproic acid during surgery. 205 patients received aprotinin and 164 received aminocaproic acid. The study found that the patients who were given aprotinin (Trasylol) during their surgery had a twofold higher risk of developing kidney failure compared to the patient group receiving aminocaproic acid. 25% of the patients receiving aprotinin (51 of the 205 patients) developed kidney failure. The results of this study confirm the results of Dr. Mangano’s earlier Trasylol study which revealed that patients who received the aprotinin had around a 50 percent increased risk of dying.

Study: Increased Incidence of Acute Kidney Injury with Aprotinin Use during Cardiac Surgery Detected with Urinary NGAL

Am J Nephrol 2008;28:576-582

• Print
• Comments
• Trackbacks

December 30, 1993 – Aprotinin (Trasylol) Receives FDA Approval
The Food and Drug Administration announces the approval of aprotinin, a drug used to control excess bleeding in bypass heart surgery patients.
The FDA stated that the use of Trasylol should be reserved for heart surgery patients with a high risk of excessive bleeding. During clinical trials kidney toxicity was reported as a problem in some patients.

January 20, 2006 – Trasylol Associated With Renal Toxicity
Karkouti, et al. publishes an article in the journal Transfusion suggesting a link between aprotinin and kidney problems among cardiopulmonary bypass patients.

January 26, 2006 – Risks Associated with Aprotinin in Cardiac Surgery
The New England Journal of Medicine publishes an article by Mangano et al. reporting an association of Trasylol (aprotinin injection) with serious kidney problems and heart attacks. The study found that patients who were given aprotinin were more than twice as likely to have kidney failure requiring dialysis, a 55% increase of heart failure and a 181% increase in stroke. The authors advised against further use of the drug, since safer, cheaper alternatives are available.

February 8, 2006 – FDA Public Health Advisory
Following two studies associating the use of Trasylol with increased risk of kidney failure, heart and central nervous problems after heart surgery, the FDA issued a public health advisory. The FDA recommended limiting Trasylol use to those situations where the clinical benefit of reduced blood loss outweighs the potential risks.

September 21, 2006 –Cardiovascular and Renal Drugs Advisory Committee
The FDA holds a public meeting to discuss the safety and overall risk-benefit profile for Trasylol. The committee supports acceptable safety and efficacy for Trasylol among coronary artery bypass graft (CABG) surgery patients.

September 27, 2006 – Additional Study Revealed by Bayer
Bayer Pharmaceuticals reveals to the FDA that it had conducted an additional Trasylol safety study. The study shows use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. The failure of Bayer to disclose the data from the additional study seriously undermined the advisory committee process and delayed the safety review.

September 29, 2006 – FDA Public Health Advisory
Federal Drug Administration announces that Bayer failed to disclose a Trasylol study prior to the September 21, 2006 public meeting held to discuss the safety of Trasylol (aprotinin). The FDA warns doctors who administer Trasylol to carefully monitor their patients for any adverse events, in particular, problems with the kidneys, brain or heart. Physicians treating Trasylol patients are also encouraged to report any Trasylol problems to the FDA or Bayer Pharmaceuticals.

October 13, 2006 – Bayer Suspends Employees Over Trasylol Study
Following the failure to reveal a Trasylol safety study, Bayer has suspended two employees in what seems like an attempt to justify why the study was not disclosed. The safety trial results focused on the potential Trasylol risks and side effects for patients using the drug during bypass heart surgery. The suspended Bayer employees are members of the Germany Drug Safety Group.
The Federal Drug Administration began reviewing Trasylol after two published studies associated the drug with serious side effects including kidney damage, heart attacks, and stroke.
The FDA panel had concluded that Trasylol was safe and effective but issued a warning on the product after reviewing the newly revealed data. Bayer stated that it had mistakenly failed to reveal the data because of its preliminary nature and did not attempt to knowingly withhold Trasylol study data from the panel.

December 15 2006 – FDA Revises Trasylol Labeling and Strengthens Safety Warnings
Following a review of safety information conduced by the Food and Drug Administration the Trasylol labeling was changed. The review, which started in January 2006, was prompted by Trasylol studies that showed an increased risk of kidney failure, heart attack and stroke in patients who were given Trasylol during heart surgery. The new labeling limits the drugs usage to specific situations where the patient has an increased risk for blood loss during surgery.

November 5 2007 – Bayer Withdraws Trasylol From the Marketplace
Bayer stopped selling the heart surgery drug Trasylol after studies linked the drug to a 50 percent higher risk of death than other drugs in the clinical trial. The FDA requested that Bayer withdraw Trasylol from the marketplace until further studies could be reviewed.

• Print
• Comments
• Trackbacks

Bayer discontinued three Trasylol clinical studies which were set up to look at expanding the use of the drug. Trasylol is currently approved to help reduce blood loss in bypass heart surgery patients who are at a high risk of excessive bleeding and blood transfusion.

The clinical trials for Trasylol were set up to explore the safety and efficacy of Trasylol in areas such as spinal-fusion surgery, pneumonectomy, esophagectomy for cancer, and total cystectomy for cancer.

Bayer stated they halted the studies following an FDA Trasylol labeling change that Trasylol should only be used in certain surgical procedures with patients who are at an increased risk for blood loss and blood transfusion and where cardiopulmonary bypass is available. Bayer maintains that the Trasylol studies were not terminated for safety reasons.
According to Dr. Steven Galson, the Director of FDA's Center for Drug Evaluation and Research, "The purpose of the label change is to inform physicians and patients about the risks associated with Trasylol and to ensure they understand the new warnings and use the product as directed by the label."

• Print
• Comments
• Trackbacks

For help with a referral to an Alabama Trasylol lawyer contact our Trasylol Lawsuit Team for a free consultation. If you or a loved one has suffered from kidney failure or died following heart surgery you may be entitled to compensation.

Below is a directory of kidney failure dialysis centers in Alabama. If you suffer from kidney failure and suspect that Trasylol / Aprotinin was the cause, these centers may be able to help you with your kidney dialysis.

Alabama Kidney Dialysis Centers

Alabaster

Ala Dialysis Svs - Shelby

Andalusia

Renal Care Group - Andalusia

Anniston

Renal Care Group - Anniston #2

Renal Care Group - East Alabama #1

Athens

Gambro Healthcare – Athens

Atmore

Atmore Dialysis Center

Bay Minette

Fresenius Medical Care (FMC) - Bay Minette

Bessemer

Bessemer Kidney Center

Gambro Healthcare - Bessemer

Birmingham

Ala Dialysis Svs - Birmingham Ala Dialysis Svs - Montclair Ala Dialysis Svs - Southside Ala Dialysis Svs - West Childrens Hospital Dialysis Unit Dialysis Clinic, Inc. - Birmingham Fresenius Medical Care (FMC) - Norwood Gambro Healthcare - Birmingham Central Gambro Healthcare - Birmingham East Gambro Healthcare - Birmingham H.T. Gambro Healthcare - Birmingham North Gambro Healthcare – Ensley Boaz Gambro Healthcare – Boaz Brewton Dialysis Affiliates Of South Alabama Camden Fresenius Medical Care (FMC) - Wilcox Clanton Alabama Dialysis Svs. Clanton Fresenius Medical Care (FMC) - Chilton Peach Cullman Dialysis Clinic, Inc. - Cullman   Dadeville Fresenius Medical Care (FMC) - Dadeville Decatur Dialysis Clinic, Inc. – Decatur Demopolis Gambro Healthcare - Demopolis

Dothan Dialysis Clinic, Inc. - Dothan Gambro Healthcare – Dothan Enterprise Dialysis Clinic, Inc. – Enterprise Eufaula Dialysis Clinic, Inc. - Eufaula Gambro Healthcare Eufaula Eutaw Gambro Healthcare - Greene County Dx Fairfiled Ala Dialysis Svs – Fairfield Fairhope Fresenius Medical Care (FMC) - Eastern Shore Fayette Gambro Healthcare - Fayette Florence Gambro Healthcare - Florence Foley South Baldwin Dialysis Center Fort Payne Ala Dialysis Svs - Fort Payne Gadsden

Gambro Healthcare - Gadsden Gardendale Fresenius Medical Care (FMC) - Gardendale

Georgiana Dialysis Clinic, Inc - Georgiana

Guntersville

Fresenius Medical Care (FMC) Dialysis Services Of Lakeview

Hamilton

Ala Dialysis Svs - Hamilton

Huntsville

Fresenius Medical Care (FMC) - Huntsville 

Fresenius Medical Care (FMC) - North Alabama

Fresenius Medical Care (FMC) - Parkway Dialysis Center  

Fresenius Medical Care (FMC) Chase Dialysis Center

Jackson

Fresenius Medical Care (FMC) - Jackson (Tombigbee)

Jasper

Ala Dialysis Svs - Walker    

Fresenius Medical Care (FMC) – Walker

Lafayette

Fresenius Medical Care (FMC) - Chambers

Madison

Fresenius Medical Care (FMC) - Odyssey Dialysis

Mobile

Fresenius Medical Care (FMC) - Dauphin Island Pkwy     

Fresenius Medical Care (FMC) - East Mobile

Fresenius Medical Care (FMC) - Mobile      

Fresenius Medical Care (FMC) - Port City Dialysis

Fresenius Medical Care (FMC) - Toulminville         

Fresenius Medical Care (FMC) - University South Alabama

Fresenius Medical Care (FMC) - West Mobile

Monroeville

Fresenius Medical Care (FMC) - Monroeville (Whetstone)

Montgomery

Dialysis Clinic, Inc. - Montgomery  

Fresenius Medical Care (FMC) - Capitol City

Fresenius Medical Care (FMC) - Montgomery Baptist       

Physicians Choice Dialysis Of Al, LLC - East Montgomery

Physicians Choice Dialysis Of Al, LLC - Montgomery        

Moulton

Dialysis Clinic, Inc. - Moulton

Northport

Gambro Healthcare - Northport

Oneonta

Ads Oneonta

Opelika

Fresenius Medical Care (FMC) - Opelika

Ozark

Gambro Healthcare - Ozark

Pelham

Ala Dialysis Svs - Cahaba Valley

Pell City

Ala Dialysis Svs - Pell City  

Dialysis Clinic, Inc. - Pell City

Phenix City

Dialysis Clinic, Inc - Phenix City    

Phenix City Dialysis Center

Prattville

Physicians Choice Dialysis Of Al, LLC - Prattville

Prichard

Fresenius Medical Care (FMC) - Prichard

Rainbow City

Gambro Healthcare - Rainbow City

Roanoke

Roanoke Dialysis Clinic

Russellville

Gambro Healthcare - Russellville

Scottsboro

Fresenius Medical Care (FMC) - Scottsboro

Selma

Fresenius Medical Care (FMC) - Dallas County     

Fresenius Medical Care (FMC) – Selma

Semmes

BMA - Magnolia

Sheffield

Gambro Healthcare - Sheffield

Sylacauga

Ala Dialysis Svs - Sylacauga         

Gambro Healthcare – Sylacauga

Talladega

Renal Care Group - Talladega

Thomasville

Dialysis Clinic, Inc - Thomasville    

Fresenius Medical Care (FMC) – Thomasville

Troy

Fresenius Medical Care (FMC) - Troy

Tuscaloosa

Gambro Healthcare - Tuscaloosa   

Gambro Healthcare - Tuscaloosa – University

Tuskegee

Fresenius Medical Care (FMC) - Tuskegee

Union Springs

Dialysis Clinic, Inc. - Union Springs

Valley

Fresenius Medical Care (FMC) - Langdale

Wetumpka

Physicians Choice Dialysis Of Al, LLC - Elmore County

• Print
• Comments
• Trackbacks

For help with a referral to an Alaska Trasylol lawyer contact our Trasylol Lawsuit Team for a free consultation. If you or a loved one has suffered from kidney failure or died following heart surgery you may be entitled to compensation.

Below is a directory of kidney failure dialysis centers in Alaska. If you suffer from kidney failure and suspect that Trasylol / Aprotinin was the cause, these centers may be able to help you with your kidney dialysis.

Alaska Kidney Dialysis Centers

Anchorage
Renal Care Group Inc Anchorage


Fairbanks
Renal Care Group Inc Fairbanks

• Print
• Comments
• Trackbacks

For help with a referral to an Arizona Trasylol lawyer contact our Trasylol Lawsuit Team for a free consultation. If you or a loved one has suffered from kidney failure or died following heart surgery you may be entitled to compensation.

Below is a directory of kidney failure dialysis centers in Arizona. If you suffer from kidney failure and suspect that Trasylol / Aprotinin was the cause, these centers may be able to help you with your kidney dialysis.

Arizona Kidney Dialysis Centers

Apache Junction
Renal Care Group Inc - Apache Junction

Bullhead City
Fresenius Medical Care (FMC) - Bullhead City Dialysis

Casa Grande
Renal Care Group Inc - Casa Grande
Western Skies Dialysis, Inc.

Chandler
Renal Care Group Inc - Chandler

Chinle
Davita - Four Corners Dial Clinic Chinle

Cottonwood
Renal Care Group Inc - Cottonwood

Dewey
Arizona Peritoneal Dialysis

Flagstaff
Fresenius Medical Care (FMC) - Flagstaff Dialysis Center

Gilbert
Fresenius Medical Care (FMC) Mesa Dialysis Center

Glendale
Fresenius Medical Care (FMC) - Dialysis Center Of Glendale
Fresenius Medical Care (FMC) Arrowhead Dialysis
Glendale Family Health Center
Renal Care Group Inc – Glendale

Goodyear
Fresenius Medical Care (FMC) Palm Valley Dialysis

Kayenta
Davita - Four Corners Dial Clinic Kayenta


Kingman
Fresenius Medical Care (FMC) - Kingman Renal Dialysis Center
Kingman Kidney Center, Inc.

Lake Havasu
Renal Care Group Inc - Lake Havasu

Mammoth
Renal Care Group Inc - Mammoth

Maricopa
Renal Care Group Inc - Ak - Chin

Mesa
Fresenius Medical Care (FMC) Red Mountain Dialysis
Renal Care Group Inc - East Valley
Renal Care Group Inc - Home Dialysis Of Mesa
Renal Care Group Inc - Mesa
Renal Care Group Inc - Southwest Mesa

Miami
Renal Care Group Inc - Globe

Nogales
Gambro Healthcare Of Nogales

Parker
Fresenius Medical Care (FMC) Parker Dialysis Center

Payson
Renal Care Group Inc - Payson

Peoria
Phoenix Artificial Kidney Center

Peridot
Renal Care Group Inc - San Carlos

Phoenix
Central Phoenix Dialysis
Davita - Papago
Fresenius Medical Care (FMC) - Arcadia Dialysis Center
Fresenius Medical Care (FMC) - Desert Valley Dialysis
Fresenius Medical Care (FMC) - Estrella Dialysis Center
Fresenius Medical Care (FMC) - South Mountain Dialysis Center
Fresenius Medical Care (FMC) - South Phoenix Dialysis Services
Fresenius Medical Care (FMC) Dialysis Services Of Deer Valley
Fresenius Medical Care (FMC) Dialysis Services Of Saguaro
Fresenius Medical Care (FMC) North Phoenix Dialysis
Good Samaritan Med. Center/Kidney Center
Maricopa Medical Center/Dialysis
Phoenix Children's Hospital - Kid's Kidney Center
Renal Care Group Inc - Awhatukee
Renal Care Group Inc - Maryvale
Renal Care Group Inc - North East Phoenix
Renal Care Group Inc - Phoenix North
Renal Care Group Inc - Phoenix
Renal Care Group Inc - South Phoenix
Polacca
Davita - Hopi Dialysis Center

Prescott
Renal Care Group Inc - Prescott

Prescott Valley
Fresenius Medical Care (FMC) Prescott Valley Dialysis
Sacaton
Renal Care Group Inc - Native American

Safford
Renal Care Group Inc - Safford

Scottsdale
Davita - Camelback Dialysis
Davita - Desert Mountain Dialysis
Davita - Scottsdale Dialysis Center
Fresenius Medical Care (FMC) North Scottsdale
Renal Care Group Inc - Salt River Dialysis Center
Renal Care Group Inc – Scottsdale

Sells
Gambro Healthcare Sells


Show Low
Renal Care Group Inc - Show Low

Sierra Vista
Gambro Healthcare Sierra Vista



Sun City
Davita - Palm Brook Dialysis Center
Desert Dialysis Srvs, Inc. - Sun City
Renal Care Group Inc - Sun City

Sun City West
Fresenius Medical Care (FMC) Granite Valley
Renal Care Group Inc - Sun City West Dialysis

Sun Lakes
Renal Care Group Inc - Sun Lakes

Surprise
Fresenius Medical Care (FMC) - - Sun City West Dialysis

Tempe
Fresenius Medical Care (FMC) Dialysis Services Of Tempe
Renal Care Group Inc – Tempe

Tuba City
Davita - Tuba City Dialysis Unit

Tucson
Carondelet - St. Joseph's Dialysis
Carondelet - St. Mary's Dialysis
Dci/Desert Dialysis Center South Tucson
Dci/Desert Dialysis Center
Gambro Healthcare Pascua Yaqui Tr
Gambro Healthcare Tucson East
Gambro Healthcare Tucson South Central
Gambro Healthcare Tucson South
Gambro Healthcare Tucson West
Tucson Medical Center/Dialysis

Whiteriver
Renal Care Group Inc - Whiteriver


Winslow
Fresenius Medical Care (FMC) - Winslow Dialysis Center, Ltd.

Yuma
Gambro Healthcare Of South Yuma
Gambro Healthcare Of Yuma

• Print
• Comments
• Trackbacks

For help with a referral to an Arkansas Trasylol lawyer contact our Trasylol Lawsuit Team for a free consultation. If you or a loved one has suffered from kidney failure or died following heart surgery you may be entitled to compensation.

Below is a directory of kidney failure dialysis centers in Arkansas. If you suffer from kidney failure and suspect that Trasylol / Aprotinin was the cause, these centers may be able to help you with your kidney dialysis.

Arkansas Kidney Dialysis Centers

 

Arkadelphia

Degray Kidney Center

Batesville

Batesville Dialysis Center

Benton

Renal Care Group Inc - Benton      

Saline County Dialysis Center

Bentonville

Hidden Springs Dialysis Clinic

Blytheville

Fresenius Medical Care (FMC) - Blytheville

Camden

Camden Regional Dialysis Center   

Ouachita Valley Kidney Center

Conway

Conway Dialysis Center      

Renal Care Group Inc – Conway

Crossett

Ashley Kidney Center

Dumas

Usrc Of Se Arkansas - Dumas

El Dorado

South Arkansas Kidney Center - El Dorado

Fayetteville

Fayetteville Dialysis Clinic

Fordyce

Fordyce Dialysis

Forrest City

Fresenius Medical Care (FMC) - St Francis County Dialysis

Fort Smith

Fort Smith Regional Dialysis Center

Harrison

North Ar Regional Medical Center Dialysis

Helena

Renal Care Group Inc - Helena

Hope

Hempstead County Dialysis Unit    

Hope Dialysis Center

Hot Springs

Hot Springs Dialysis 

Ouachita Regional Dialysis Center

Jacksonville

Dialysis Centers Of Arkansas - Jacksonville         

Jacksonville Dialysis Center

Jonesb