Back to Trasylol®

This Food and Drug Administration (FDA) alert highlights important revisions to the full prescribing information for Trasylol® (aprotinin). The new labeling for Trasylol® has a new warning about renal dysfunction, a revised warning about anaphylactic reactions, and a new contraindication. Trasylol® is now indicated only for preventative use to reduce blood loss and the need for blood transfusion in patients who are at an increased risk for blood loss undergoing coronary artery bypass grafting (CABG) surgery.

Trasylol® should not be used with any patient with a known or suspected exposure to aprotinin within the past 12 months.

The new Trasylol® labeling changes include:

• Indication and Usage - Trasylol® is now indicated for use only in patients who are at increased risk for blood transfusion or blood loss in association with CABG surgery. Aprotinin should only be administered in the operative setting where cardiopulmonary bypass can be rapidly initiated.
• Warning - Trasylol® increases the risk for renal dysfunction and may increase the need for dialysis. Also, anaphylactic reactions, including fatal reactions, are one of the important risks associated with Trasylol®.
• Contraindication - 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.

Recommendations and considerations for doctors and other heath care professionals:

• Promptly report serious and unexpected adverse Trasylol® side effects to the drug Bayer and to the FDA MedWatch program.
• When using Trasylol®, carefully monitor your patient for the occurrence of toxicity, particularly to the kidneys, heart, or central nervous system.
• Limit the use of Trasylol® to those situations where the clinical benefit of reduced blood loss is essential and the benefit outweighs the risks.
• Monitor patients closely for anaphylactic reactions, even when administering a test dose of Trasylol®. Anaphylactic reactions occur more frequently in patients who have been exposed previously to Trasylol® or to other aprotinin-containing products.

Information for the patient:

When a decision to treat a patient with Trasylol® has been made, doctors should discuss the following with the CABG surgery patient:

• Trasylol® can increase the patient's chance of serious kidney damage or failure that could lead to a need for kidney dialysis.
• The factors that increase the patient's chance for serious complications include previous treatment with Trasylol®, prior heart surgery, kidney disease, or drug allergies.
• Previous treatment with Trasylol® increases the chance of experiencing an anaphylactic allergic reaction, which can be life threatening.

Data Summary

Two articles published in January 2006 reported the results of two new safety studies of Trasylol®, which indicated a higher risk of death and serious renal and cardiac adverse events following treatment with Trasylol®.

Results from a study published in the New England Journal of Medicine

The New England Journal of Medicine described the findings from an observational study of 4,374 patients (1,295 treated with Trasylol®) scheduled for CABG surgery. Data was prospectively collected from patients who were prescribed either no preventive drug for blood loss or one of three drugs intended to prevent blood loss which were Trasylol®, aminocaproic acid, and tranexamic acid.

Compared to those receiving no preventive drug therapy, patients receiving Trasylol® had a higher risk for dialysis, myocardial infarction, stroke, heart failure, encephalopathy or coma. Risks for adverse renal events increased with the administered Trasylol® dose. All three medications Trasylol®, aminocaproic acid, and tranexamic acid were reported to reduce blood loss to similar extents.

New Study Results from Transfusion

Transfusion described the findings from an observational prospective study of 898 patients (449 treated with Trasylol®) undergoing coronary artery bypass grafting surgery. The rate of renal dysfunction was higher among patients receiving Trasylol® than among patients receiving tranexamic acid, especially in those with existing renal dysfunction.

Pre-Marketing Studies

The pre-marketing studies supporting Trasylol® safety and efficacy enrolled a total of approximately 3,000 patients (2,002 treated with Trasylol®). The studies consistently showed that Trasylol® decreased blood loss and the need for blood transfusion. The risks for serious renal and cardiovascular adverse events and deaths were similar between patients receiving a placebo compared to Trasylol®. The major pre-market safety signal was a risk for anaphylaxis, especially among subjects re-exposed to Trasylol®. The initial Trasylol® label carries a black box warning relating to anaphylaxis.

Post-Marketing Spontaneous Reports

Two hundred ninety-one cases of hypersensitivity associated with Trasylol®, including 52 cases of death, have been reported to Bayer. A test dose of Trasylol® was administered in 139 of the 291 cases. A hypersensitivity reaction occurred with the test dose alone in 81 cases, including 19 resulting in death.

A New Study Reported to the FDA

Following a September 21, 2006 FDA discussion of the two Trasylol® studies, Bayer informed the FDA of another observational study they had performed using a contract research organization. Existing hospital data from 67,000 records of patients undergoing CABG surgery were examined. 30,000 of the patients were treated with Trasylol® and 37,000 were treated with alternate medications. The report suggested that patients receiving Trasylol® were at increased risk for death, kidney failure, stroke, and congestive heart failure.

If you or someone you know has undergone a coronary artery bypass grafting surgery and subsequently developed the onset of kidney failure, please use the form on the left to contact our law firm.

Reference:

"Information for Healthcare Professionals Aprotinin Injection (marketed as Trasylol)," FDA, December 2006.