Arkansas Drug Injury Lawyer

Representing the Injured in Arkansas

Trasylol®

Do not discontinue taking any medications without first consulting your physician.

Trasylol Update (11/5/07)
On November 5, 2007, at the request of the FDA, Bayer suspended global marketing of Trasylol. The FDA’s request was in the interest of patient safety based on the preliminary data from the BART Study (Blood Conservation using Anti-fibrinolytics: A Randomized Trial in High-Risk Cardiac Surgery Patients).

This study was recently halted by the monitoring board after the preliminary results revealed an increase in mortality of patients who received Trasylol. The FDA will undertake a thorough analysis of the data from the BART study. In their posted information, the FDA added, “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.”

Trasylol Update (10/25/07)
On October 25, 2007, the FDA released information that an important trial called Blood Conservation Using Antifibrinolytics: A Randomized Trial in a Cardiac Surgery Population Study (BART) had stopped patient enrollment.

This study was being conducted by Canadian researchers from Ottawa Health Research Institute (OHRI).OHRI’s Data Safety Monitoring Board’s (DSMB) recommended enrollment be stopped because the preliminary findings suggest that, compared to the other antifibrinolytic drugs, aminocaproic acid and tranexamic acid, Trasylol (aprotinin) increases the risk of death.

The BART study was designed to test the hypothesis that Trasylol (aprotinin) was superior to epsilon-aminocaproic acid and tranexamic acid in decreasing the occurrence of massive bleeding associated with cardiac surgery. The study had planned to enroll approximately 3,000 adult Canadian patients who were to undergo various types of cardiac surgery that placed them at high risk for bleeding.

In light of the preliminary BART study findings, FDA anticipates re-evaluation of the overall risks and benefits of Trasylol. This re-evaluation may result in the need to revise the labeling or other regulatory actions. Until this process has been completed, health care providers who are considering use of Trasylol should be aware of the risks and benefits described in the labeling for Trasylol and the accumulating data suggesting Trasylol administration increases the risk for death compared to other antifibrinolytic drugs.

Trasylol is currently approved for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft (CABG) surgery who are at an increased risk for blood loss and blood transfusion.
From the FDA Early Communication about an Ongoing Safety Review Aprotinin Injection (marketed as Trasylol) 10/25/2007.

Update 10/02/06:

On September 27, 2006, Bayer Pharmaceuticals told the FDA of the results of a new study, conducted by Bayer through a contract research organization, which suggests that:

Trasylol® may increase the chance for death, serious kidney damage, congestive heart failure, and stroke.

The study was based on the records of hospital data from 67,000 patients and was announced by the FDA in a Public Health Advisory, the second of 2006, for the drug.

FDA Alert [12/2006]: This Alert highlights important revisions to the full prescribing information for Trasylol. The new labeling for Trasylol (December 2006) has a more focused indication for use, a new Warning about renal dysfunction, a revised Warning about anaphylactic reactions, and a new Contraindication. Trasylol is now indicated only for prophylactic use to reduce peri-operative blood loss and the need for blood transfusion in patients who are at an increased risk for blood loss and blood transfusion undergoing cardiopulmonary bypass in the course of coronary artery bypass grafting (CABG) surgery.

Heart Surgery Drug Doubles Risk of Kidney Failure

Trasylol, a drug frequently used during heart surgery to control bleeding, has been found to double the risk of kidney failure (1) in patients. An estimated 10,000 people are forced to undergo dialysis each year after receiving the drug, which was approved by the FDA in 1993 (2). Trasylol, generically known as aprotinin, is manufactured by Bayer AG and had projected sales estimates above $600 million in 2006 (1).

The study published in theNew England Journal of Medicine(NEJM) in January of 2006 revealed that Trasylol, in addition to doubling the risk of kidney failure in patients, also increases the risk of heart attack by 48%, heart failure by 109%, and stroke by 181%. The international study spanned 7 countries and involved more than 4,300 patients at 69 different medical facilities (2). The study also noted that the drug, while marginally more effective at controlling bleeding, is often not needed; there are two generic drugs that cost a tenth as much as Trasylol and are nearly as good, while producing no increased risk to the patient (2).

The Food and Drug Administration (FDA) followed the study’s publication by issuing a Public Health Advisory for Trasylol which stated that the FDA is “Alerting doctors who perform heart bypass surgery, and their patients, that Trasylol (aprotinin injection), a drug used to prevent blood loss during surgery, has been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks, and stroke in patients who undergo artery bypass graft surgery (3).”

The study estimates that the side effects of Trasylol have increased worldwide medical costs by more than $1 billion per year. It may be very important for you to seek a Trasylol lawyer if you or someone you care about has suffered any health complications after surgery in which Trasylol was used. A Trasylol lawyer at our firm will help you and your doctor determine if the drug may have been responsible for your injuries.

Trasylol and Kidney Damage
The kidneys are sophisticated organs vital to our survival. They function as blood cleansers and process about 200 quarts of blood to sift out about 2 quarts of waste products and extra water on a daily basis. The waste and extra water become urine and is excreted as waste.

When our kidneys fail the body reacts by retaining fluids; toxins build up, blood pressure rises, and the body cannot produce an adequate number of red blood cells for survival. This condition is known as kidney (renal) failure. Trasylol is taken up by the tubules in the kidneys and remains there for 24 hours or longer, which may interfere with natural organ function. According to the study, replacing Trasylol with one of two safe generic drugs would prevent as many as 11,050 dialysis complications a year (4).

In addition to kidney damage, Trasylol is believed to greatly increase your chance of heart complications and stroke. Let one of our Trasylol lawyers help you. Call us today.

Free Consultation
Trasylol is frequently used in heart operations, and while these surgeries are inherently dangerous, you may have been exposed to additional risks if Trasylol was used in your procedure. If you or someone you know underwent surgery with Trasylol and suffered kidney failure, heart failure, heart attack, or stroke, call us immediately to speak with a Trasylol lawyer handling any and all cases in which Trasylol caused injury. Your phone call is free, so don’t hesitate. We have intake specialists standing by for your call.