Trasylol Lawsuit & News Blog

TRASYLOL

Tue, 5 Feb 2008 08:46:42 -0500

In 1993, the US Food and Drug Adminstration approved the drug Trasylol to be manufactured by Bayer AG. Trasylol, or Aprotinin Injection, is a medication that is given to patients that have had certain types of heart bypass surgery, and is used for clotting blood to aid in the reduction of bleeding or any need for possible blood transfusions. The medication works by decreasing the risk of bleeding by inhibiting certain enzymes.

Then in January 2006, two reports were published stating that research was found linking the use of Trasylol to the cause of serious side effects such as kidney failure, stroke, and heart attack. One study was published in The New England Journal of Medicine on January 26, 2006, and suggests that patients that were undergoing coronary artery bypass grafting, or CABG, were at a higher risk for serious side effects associated with the administration of Trasylol. In the report, the occurrence to the serious kidney damage, myocardial infarctions, also known as a heart attacks, and even strokes were described in the CABG patients that were prescribed Trasylol. The report continues on to disclose that more patients are experiencing these events after receiving Trasylol than patients receiving other medications, or even, no medications at all. Yet, another study that was published on January 20, 2006 in the online edition of Transfusion, suggests that patients may be at a greater risk for kidney damage when taking Trasylol.

Trasylol has further been associated with patients suffering from Anaphylactic Reaction due to a rare, but serious, allergic reaction. As this can happen suddenly, and without warning, without immediate medical attention can be life threatening. This risk seems to be increased in patients who have taken Trasylol in the past than with a new dose of the medication.

Later, in October 2007, a Canadian based drug study that was being conducted on cardiac surgery patients was stopped due to Trasylol use appearing to cause increased health risk when compared to other blood clotting medications. Finally on November 5, 2007, Bayer AG announced the worldwide suspension of the sale of Trasylol until such time that drug trials can be more properly evaluated. The FDA and Bayer will continue to seek out the safety benefits of Trasylol during this time of the drug suspension.

Though there is a certain anticipation for any side effects when taking medications, it is the responsibility of the drug manufacturer to make all products reasonably safe, and to inform both the medical community and the public of any known associated risk due to taking any medications. Should a manufacturer choose to not disclose these risks, then the manufacturer can be held legally accountable for any injury that a patient may suffer as the result of inadequate warnings, or even the unreasonably dangerous nature that may be linked to the drug, as a result of product liability.

If there seems to be an experience related to the any dangerous side effects or symptoms that may lead back to the use of Trasylol, then click here to receive a free no obligation consultation.

Bayer Agrees to Withdraw Heart Surgery Drug - Trasylol

Tue, 6 Nov 2007 04:45:06 -0500

German pharmaceutical manufacturer, Bayer AG, agreed to withdraw the heart surgery drug Trasylol after the Canadian BART study suggested increased death rates. The Canadian study was cut short when a statistically sigfnificant death rate was found in the data. From this data, the FDA does not know of a specific patient population where the benefits of using Trasylol could outweigh the risks. Only because of concerns of shortages of other drugs, the agency seeks a phased withdrawal of Trasylol. Trasylol (Aprotinin) is used for heart surgery to reduce the risks of excessive bleeding.

Bayer is still trying to bring the drug back to the market, claiming it still thinks Trasylol is beneficial when used as directed. The drug might still be used, but only on a case by case basis, where doctors enroll their patient into a Trasylol study, where death rates and kidney failures can be carefully tracked.

The problem is widespread, as nearly 200,000 patients were administered Trasylol last year alone (over half of them in the USA). The drug has been on the market for 14 years.

This is not the first time that a study has shown problems with Trasylol. Other studies have show dangers, including a 2006 study published in The New England Journal of Medicine (NEJM) that demonstrated the drug increased the risks of kidney failure, heart attack and stroke. That research concluded that halting the drug’s use would prevent 10,000 to 11,000 cases of kidney failure a year and save more than $1 billion a year in dialysis costs.

Bayer has not been forthcoming with data it has developed on this subject. Last year, after narrowly winning FDA panel conclusion to leave the drug on the market, Bayer disclosed that it had sponsored another study of Trasylol suggesting that the drug increased the risks of death and stroke. The company waited until after the Panel had ruled in its favor before it disclosed the results of its study to the agency. Even Bayer scientists, who defended Trasylol at the panel’s hearing, did not mention their own study or its worrisome findings.

If you can believe this, Bayer said that the findings had been withheld as a result of "regrettable human error."

This drug is not the first that Bayer has produced with safety concerns. Baycol, a cholesterol drug made by Bayer, was also pulled from the market after it was shown to cause Rhabdomyolysis. Trasylol is just another example that once a drug is approved, stopping hidden dangers becomes difficult. The past two years show that the FDA can easily be fooled by drug manufacturers into approving drugs that should not be taken to market. Then, once millions of doses are given, statstically significant dangerts emerge, but by then it is too late.

FDA Requests Marketing Suspension of Trasylol

Mon, 5 Nov 2007 10:46:12 -0500

FDA Requests Marketing Suspension of Trasylol

The U.S. Food and Drug Administration (FDA) today announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.

FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.

There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.

Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.

Two weeks ago, FDA was notified that researchers with the Ottawa Health Institute stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The preliminary data from this terminated study also suggested that fewer patients receiving the drug experienced serious bleeding events.

On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to the Canadian study's termination. In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.

Subject: MedEffect/MedEffet - Trasylol

Mon, 5 Nov 2007 09:33:12 -0500

Manufacturer temporarily suspends marketing of Trasylol in Canada - Consumer Information

Health Canada has requested that Bayer Inc., maker of Trasylol, temporarily suspend sales of Trasylol (aprotinin) until a review is completed of results from the BART study. The BART study indicated an increased risk of death form use of Trasylol. Bayer Inc. is to help Health Canada provide the drug to certain patients in cases where the doctor believes the potential benefit clearly outweighs the risk.

Trasylol, used by injection during heart bypass surgery, reduces bleeding. Health Canada's review of post market safety information for Trasylol has led to this action.

Bayer Inc. has recently sent a notice to hospitals and physicians regarding the suspension of the BART study. Health Canada will continue to communicate information and recommendations related to this product to health professionals and the public.

Health Canada informed health care professionals about safety information for Trasylol on March 27, 2007 and on February 28, 2006.

Bayer Agrees to Suspend Marketing of Trasylol

Mon, 5 Nov 2007 09:28:01 -0500

WASHINGTON, D.C. -- The FDA said today that Bayer Pharmaceuticals Corp. has agreed to an agency request to suspend marketing of the company's Trasylol blood-clotting drug because of an increased risk of death.

Canada halts study of Trasylol due to deaths

Thu, 1 Nov 2007 09:32:07 -0500

Canadian study that was halted following reports of increased mortality among study participants administered the drug.

FDA anticipates re-evaluation of the overall risks and benefits of Trasylol

Fri, 26 Oct 2007 06:32:30 -0500

FDA informed healthcare professionals of the Data Safety Monitoring Board's recommendation to stop patient enrollment in the aprotinin treatment group arm of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study. The BART study was designed to test the hypothesis that aprotinin was superior to epsilon-aminocaproic acid and tranexamic acid in decreasing the occurrence of massive bleeding in association with cardiac surgery. The preliminary findings suggest that, compared to the antifibrinolytic drugs, epsilon-aminocaproic acid and tranexamic acid, aprotinin increases the risk of death.

FDA anticipates re-evaluation of the overall risks and benefits of Trasylol which may result in the need to revise the prescribing information or other regulatory actions. Healthcare professionals who are considering use of Trasylol should be aware of the risks and benefits described in the prescribing information for Trasylol and the accumulating data suggesting Trasylol administration increases the risk of death compared to other antifibrinolytic drugs.

Read the complete MedWatch 2007 Safety Summary including a link to Early Communication information regarding this issue.

Evaluating the Safety of Trasylol/aprotinin in cardiac surgery

Thu, 14 Jun 2007 10:25:23 -0500

Aprotinin (Trasylol) is a drug used to reduce bleeding in patients undergoing cardiothoracic surgery with cardiopulmonary bypass. A recent evaluation found elevated risks of renal, cardiovascular, and cerebrovascular events when aprotinin was used. This experiment determines the impact of aprotinin on safety variables among patients receiving cardiothoracic surgery with cardiopulmonary bypass from one U.S. hospital that reserves aprotinin for complex surgeries and Jehovah’s Witnesses and does not utilize celite-based activated clotting time determinations.

348 patients were evaluated from January 1, 2000 to December 31, 2005 for the use of aprotinin or lack of aprotinin in cardiothoracic surgery. The main outcome measures were odds of developing myocardial infarction, cerebrovascular events, and renal dysfunction after cardiothoracic surgery between groups.

Patients receiving aprotinin were less likely to experience a cerebrovascular event and did not have elevated odds of myocardial infarction but were more likely to experience postoperative renal dysfunction.

Aprotinin was not associated with negative myocardial or cerebrovascular risks but did increase the risk of renal dysfunction. It is not known whether the renal dysfunction reflects renal damage.

Source: Journal of Thoracic and Cardiovascular Surgery - (Abstract) http://jtcs.ctsnetjournals.org/cgi/content/abstract/133/6/1547

Aprotinin Injection (marketed as Trasylol) Information

Sat, 5 May 2007 11:56:08 -0500

Aprotinin Injection (marketed as Trasylol) Information - http://www.fda.gov/cder/drug/infopage/aprotinin/default.htm

Updated December 2006--New labeling for Trasylol has a more focused indication, a new Warning about renal dysfunction, a revised Warning about anaphylactic reactions, and a new Contraindication. Trasylol new labeling changes are:

Indication and Usage-more limited and focused
Trasylol is now indicated for use only in patients who are at increased risk for blood loss and blood transfusion in association with cardiopulmonary bypass in the course of coronary artery bypass grafting. It should be administered only in the operative setting where cardiopulmonary bypass can be rapidly initiated.
A new Warning about renal dysfunction - Trasylol administration increases the risk for renal dysfunction and may increase the need for dialysis in the peri-operative period.

Stronger Warnings about anaphylactic reactions including a new Contraindication for previous aprotinin exposure. Anaphylactic reactions, including fatal reactions, are one of the important risks associated with Trasylol administration. As a consequence of the higher risk for anaphylactic reactions, administration of Trasylol to patients with a known or suspected exposure during the past 12 months is contraindicated.

The Risk Associated with Aprotinin Cardiac Surgery

Thu, 3 May 2007 11:49:10 -0500
The Risk Associated with Aprotinin Cardiac Surgery - http://content.nejm.org/cgi/content/abstract/354/4/353
The majority of patients who undergoing surgical treatment for ST-elevation heart attacks receive antifibrinolytic therapy to limit blood loss. This approach appears counterintuitive to the accepted medical treatment of the same condition - namely, fibrinolysis (blood clots) to limit thrombosis. Despite this concern, no large-scale safety assessment has been undertaken.
An observational study was done with 4,374 patients undergoing revascularization (reviving the heart). Three agents were assessed: 1,295 patients were administered aprotinin (Trasylol), 883 patients were administered aminocaproic acid, and 882 patients received tranexamic acid while 1,374 patients received nothing.
The use of aprotinin was associated with a doubling in the risk of renal failure requiring dialysis among patients undergoing complex coronary-artery. Similarly, use of aprotinin was associated with a 55 percent increase in the risk of heart attack or heart failure and a marked increase in the risk of stroke or encephalopathy (brain disease associated with dementia).
Neither aminocaproic acid nor tranexamic acid was associated with an increased risk of renal, cardiac, or cerebral events. All the agents reduced blood loss but with aprotinin - at what risk?
In contrast, the less expensive generic medications -- aminocaproic acid and tranexamic acid are safe alternatives.