Trasylol Lawyer & Attorney : Fields Law Firm : Trasylol Injury, Kidney & Heart Failure

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.
 

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In light of the number of people suffering from Trasylol related kidney failure and other side effects such as strokes and heart attacks the number of Trasylol lawsuits being filed continues to rise. Later this year the Supreme Court will hear the case of Wyeth v. Levine which asks the vital 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 scope 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.

For the latest legal information please visit our Trasylol lawsuit center.
 

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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.

 

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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.

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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.

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COLOGNE, Germany – Bayer’s CEO stated that Bayer AG is facing 78 Trasylol lawsuits in the United States as a result of its heart surgery drug. "We are not aware of any lawsuit outside the United States," Werner Wenning told a shareholders' meeting.

Trasylol affects the way in which blood clots. Prior to the drug’s removal from the market it was given to open bypass surgery patients to prevent excessive bleeding. Trasylol was mainly used during repeat coronary artery bypass surgery to reduce the amount of bleeding both during and after surgery. 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. 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.

Bayer withdrew their heart surgery drug Trasylol from the marketplace late in 2007 following a Canadian study that linked Trasylol with an increased risk of death and kidney failure. Bayer plans on defending Trasylol claims vigorously, however they are facing the potential of thousands of lawsuits from individuals and families throughout the country as more people discover that Trasylol was used during their heart surgery

For more information regarding a Trasylol lawsuit please call Fields Law Firm or e-mail us for a free confidential consultation. We are presently representing patients and families throughout the United States. We have additional information available at our national Trasylol lawsuit website.

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On November 5, 2007, Bayer agreed to a Trasylol recall or as it was announced by the Food and Drug Administration, a “marketing suspension” of its heart surgery drug which has been associated with serious risks such as kidney failure, heart problems and death. Trasylol is a drug that was designed to control bleeding during heart surgery. Two weeks before the FDA’s announcement, researchers from the Ottawa Health Institute notified the FDA that they had stopped a study on Trasylol because it appeared to increase the risk of death for patients, compared to two other drugs used in the study.

Dr. Dennis Mangano, a medical researcher had published a revealing study in the New England Journal of Medicine in January 2006 prior to the Trasylol recall. His study showed that patients who had been given Trasylol had twice the rate of kidney failure and an increased risk of strokes, heart attacks and encephalopathy (a type of brain disease).

After the Trasylol recall, two studies published on February 28, 2008 in the New England Journal of Medicine confirmed that bypass patients who were given Trasylol had an increased risk of death. The release of these studies follows an interview of Dr. Dennis Mangano on the TV show 60 Minutes. Dr. Mangano stated that in his opinion the FDA should have pulled Trasylol from the market after his study was released in January 2006. It is estimated that approximately 413,000 patients received Trasylol between the time of his study and the time of the recall. According to Dr. Mangano, 22,000 lives could have been saved if the drug had been taken off the market in January 2006.

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On Sunday, February 17, 2008, the CBS news show 60 Minutes, featured a story concerning the serious side effects from Bayer's heart surgery drug called Trasylol. According to the 2006 study by medical researcher Dr. Dennis Mangano, the most serious and common complications associated with Trasylol were increased incidents of renal and kidney failure and heart attacks. His observational study included over 5000 patients around the world. When asked about his Trasylol study, Dr. Mangano told 60 Minutes' that, "It showed an important association between Trasylol use and kidney failure requiring dialysis and it showed a trend towards increased death in hospitals in these patients."

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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.

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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.

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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.

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On Sunday, February 17, the lead story on 60 Minutes was Bayer's heart surgery drug Trasylol. Kidney failure and heart attacks are the two main side effects associated with Trasylol according to the 2006 study by medical researcher Dr. Dennis Mangano. His observational study included over 5000 patients in 17 countries. Dr. Mangano told 60 Minutes' correspondent Scott Pelley that "[I]t showed an important association between Trasylol use and kidney failure requiring dialysis and it showed a trend toward increased death in hospital in these patients."

The story also profiled the Trasylol patient Joe Randone. He went in for heart valve replacement surgery at the age of 52. Following surgery where Trasylol was put in Mr. Randone's IV, he suffered two heart attacks and kidney failure. Over an eight month period of time he had 19 operations. In August 2006 Mr. Randone died from complications. The family has filed a Trasylol lawsuit against Bayer. Dr. Mangano estimated that 1000 lives per month could have been saved if the drug had been taken off the market after his Trasylol study was published.

Pelley also interviewed Dr. William Hiatt, the chair of the FDA's advisory committee that was presented with the Mangano study in 2006. Dr. Hiatt stated that Bayer did not disclose their own study which confirmed Dr. Mangano's findings and Hiatt's FDA committee voted to keep Trasylol on the market. The following week the author of the Bayer study, Alexander Walker, blew the whistle on Bayer and presented the study to the FDA.

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Bayer's heart surgery drug Trasylol was withdrawn from the market in November 2007 at the request of the Federal Drug Administration (FDA) following a study that found Trasylol increased the risk of kidney damage and death in heart bypass patients. It is estimated that Trasylol kidney damage results in over $1 billion in health care costs every year.

The Trasylol study was first published in January 2006, however Bayer failed to disclose the study to the FDA until after an advisory panel meeting in September 2006. The study's researcher, Dr. Dennis Mangano, said that 22,000 patients could have been saved if Trasylol had been taken off the market when the January 2006 study was first published. Before the Trasylol recall, the drug was given to around one third of heart bypass surgery patients in the United States.  Bayer is currently facing Trasylol lawsuits throughout the United States brought by patients suffering from kidney failure and wrongful death claims filed by families on behalf of loved ones who died after using the drug.

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On November 5, 2007 the Food and Drug Administration (FDA) announced that Bayer Pharmaceuticals Corp. has suspended the sale of Trasylol. Recall of this controversial drug at the request of the FDA was based on preliminary data from a Canadian study that compared heart surgery drugs used to prevent excessive bleeding.

The Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study was halted on October 19, 2007 due to the increased mortality in patients in the aprotinin (Trasylol) treatment group. The other anti-bleeding drugs in the study, aminocaproicacid and tranexamic acid, did not have the same increased risk of death compared to aprotinin. The study had planned to enroll around 3,000 adult Canadian patients who were going to have various types of cardiac surgery that put them in a high risk category for bleeding.

The FDA began taking a closer look at the safety of Trasylol in January 2006 after the publication of studies that linked the drug to dangerous side effects including heart attacks, kidney problems and strokes. In light of the initial BART study information, the FDA anticipates re-evaluating the risks and benefits of Trasylol. The FDA is working with Bayer to carefully phase Trasyol out of the marketplace in an attempt to prevent shortages of other drugs used prevent excessive bleeding during cardiac surgery.

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Recent studies have shown that 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 was linked to increased risk of kidney failure, heart attack or stroke. The 2006 Mangano study found that Trasylol was associated with 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. 

Given the much less expensive and safer alternative heart surgery drugs, physicians have been advised to consider limiting the use of Trasylol. Patients undergoing bypass surgery should discuss with their treating doctor if they are considering administering any clotting medications during the surgery. 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.

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Most people who were given Trasylol do not know if they received the drug during their open-heart surgery. The surgeon made the decision whether to use an anti-bleeding drug. A patient who has undergone heart surgery needs to review their medical records to find out if they were given Trasylol. Most patients have to pay for copies of their medical records which can often cost more than one dollar per page. Given the large volume of records this can often lead to a bill for many patients of more than a thousand dollars just to find out if Trasylol was used during their surgery.

A good strategy to use when trying to find out if Trasylol was used is to contact the records department of the hospital where the heart surgery was performed. Instead of requesting all of your records, ask if you can get copies of just the surgeon's notes and the medication reports. This dramatically reduces the number of medical records you receive and have to pay for and should show whether you received Trasylol during your heart surgery.

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 Trasylol attorney who can help you in requesting and reviewing the appropriate records.

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The lead author of the 2006 Trasylol side effects study published in the New England Journal of Medicine, Dr. Dennis Mangano, has stated that Trasylol problems occurred with greater frequency than those associated with the pain medication 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 Trasylol side effects 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's opinion in respect to the future use of Trasylol was strongly worded: "In good conscience, I could not administer (Trasylol) to this group of patients, especially given the availability of safer alternatives." The FDA is reviewing current Trasylol side effects information and studies and advising doctors to consider limiting the medicine's use.

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Two Bayer employees have been suspended in connection with the company's failure to disclose trial results about the risks of Trasylol (aprotinin), used to reduce blood loss during heart surgery. The suspended employees are senior members of Bayer's Germany Drug Safety Group.

The FDA began reviewing Trasylol following two published studies that linked the drug with serious side effects including kidney damage, heart attacks, and stroke.

Bayer admitted that it failed to keep the FDA informed of data that could have had a bearing on the outcome of an advisory panel meeting looking at the safety of Trasylol, and whether its use increased the risk of kidney problems, heart attacks and strokes. The FDA panel had concluded that Trasylol was safe and effective but issued a warning on the product after seeing the new data. Bayer stated that it had mistakenly failed to reveal the data because of its preliminary nature.

"Bayer has acknowledged and regrets the error it made in not sharing with the FDA information regarding this study prior to the September 21st Advisory Committee Meeting on Trasylol. Bayer immediately initiated a full investigation into the matter and based on our investigation so far, we believe this was a serious error in judgment by two individuals," commented Dr Roland Hartwig, General Counsel, Bayer.

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The FDA announced that it has approved revised labeling for Bayer Pharmaceuticals’ Trasylol (aprotinin) injection to strengthen its safety warnings and to narrow its usage to specific situations. Trasylol is indicated for administration to patients before cardiac surgery to reduce bleeding and the need for blood transfusions.

The new labeling states that Trasylol should only be used in patients who are at an increased risk for blood loss and blood transfusion while on cardiopulmonary bypass pump during coronary bypass graft surgery. The new labeling includes warnings of an increased risk for kidney damage and hypersensitivity reactions, as well as methods to manage and reduce these reactions.

Bayer was criticized by the FDA in October for withholding data from a retrospective study that linked Trasylol with increased risk of kidney failure, death, heart failure, and strokes.

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The Federal Drug Administration's Cardiovascular and Renal Drug Advisory Committee met on September 21, 2006 to review current Trasylol study results regarding Trasylol side effects. The committee evaluated the published studies and the global safety and efficacy database submitted by Bayer. After reviewing all the data that was made available, the FDA committee decided that there was not enough evidence to require an updated warning on Trasylol's labeling and agreed that the published data supported an acceptable safety level for Trasylol.

On September 29, 2006, days after the committee meeting, the FDA received new data from Bayer regarding an additional Trasylol study that it had failed to reveal prior to the committee meeting. It was learned that Bayer had commissioned an observational study involving 67,000 patients who were given Trasylol (aprotinin). Preliminary review of the new study data shows a potential for increased risk of Trasylol side effects including heart failure, stroke, kidney failure, and death. There is conflicting information as to why Bayer failed to disclose this important Trasylol study during the FDA's Committee meeting on September 21, 2006.

The FDA issued a public health advisory on September 29, 2006, stating that it had received new information regarding a Trasylol study that Bayer had not disclosed prior to the committee meeting. Analysis of the Trasylol study data is ongoing at the FDA, however the initial review of the study shows aprotinin may be associated with "increased risk for death, kidney failure, congestive heart failure and stroke."

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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."

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The latest Trasylol study which was published in the Journal of the American Medical Association reveals that the drug appears to increase the risk of dying by nearly 50 percent in the five years following heart surgery.

The international study tracked 3,876 heart bypass surgery patients in 62 medical centers around the world. Over five years, 20.8 percent of the Trasylol patients died compared to 12.7 percent of patients who did not receive an anti-bleeding drug. Adjusting for various factors, the researchers found that patients receiving Trasylol had a 48 percent increased risk of dying in the five years afterward.

The lead author of the study, Dr. Dennis Mangano, advises patients to discuss with their treating doctor what anti-bleeding drug they might be given during their heart surgery and the associated risks. Past patients should also look into whether they were given Trasylol so they and their doctors can monitor for any problems. "I believe that for the vast majority of coronary bypass patients the drug should not be used," Mangano stated.

The researchers said that replacing Trasylol (Aprotinin) with one of the other cheaper medications would prevent 10,000 deaths over a five year period. Bayer has stated it will "work with regulatory agencies and external experts in the field to further evaluate the findings."

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