Health Canada

Health Canada

September 21, 2011 15:53 ET

Health Canada Decision on Trasylol (Aprotinin)

OTTAWA, ONTARIO--(Marketwire - Sept. 21, 2011) - Health Canada is advising Canadians of the outcome of its comprehensive safety review of the heart-surgery drug Trasylol (the brand name for aprotinin).

After careful review, Health Canada has concluded that the benefits of Trasylol outweigh the risks when Trasylol is used as authorized by Health Canada. Trasylol is authorized for patients undergoing Coronary Artery Bypass Graft (CABG) surgery, also known as heart bypass surgery. The evidence does not suggest an increased risk of death in this use. As a result of this assessment, the manufacturer, Bayer Inc., can resume the marketing of Trasylol in Canada.

Trasylol is used to prevent life-threatening blood loss during CABG surgery. Patients undergo CABG surgery to improve blood flow to the heart when they are at a high risk of heart attack and even death due to blocked arteries. Trasylol reduces bleeding, which means blood transfusions are either not necessary or a smaller amount of blood is transfused. This in turn, lowers the risk of complications for the patient.

New safety measures have been put in place to address new safety information identified during Health Canada's review. Health Canada has requested that strong warnings be added to the prescribing information emphasizing that there have been reports of an increased risk of death in some studies associated with Trasylol use outside of its authorized indication, and that Trasylol should only be used as authorized after careful consideration of the potential benefits and risks. Warnings have also been added emphasizing that physicians should adhere to the recommended procedures for the management of blood clotting, and that Trasylol increases the risk of kidney problems.

Trasylol marketing was temporarily suspended in November 2007 at Health Canada's request after a clinical trial, the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) study, was stopped due to a higher number of deaths in patients receiving Trasylol relative to two drugs also used to reduce blood loss. The BART study included higher-risk patients undergoing complex cardiac surgeries, a use for which Trasylol and the other two drugs are not authorized in Canada.

Health Canada's decision is based on a comprehensive review of the totality of evidence, which included an evaluation of BART study data, other clinical trial data, post-market studies, and information from Bayer as well as an Expert Advisory Panel on Trasylol that was convened by Health Canada.

Summary of Key Findings:

  • Evidence from clinical trials and post-market studies continues to support that Trasylol benefits outweigh the risks when it is used as authorized by Health Canada: for basic CABG surgery.
  • Clinical trial data involving Trasylol use as authorized does not show an increased risk of death.
  • Data suggesting an increased risk of death involved use of Trasylol in complex, higher-risk surgeries for which it is not authorized, such as valve replacement/repair. The precise nature of this risk remains unclear and merits further study.
  • With respect to the BART study, Health Canada concluded that the study was not designed to reliably determine the risk of death (either within or outside of CABG surgery) relative to the two drugs it was being compared against, and that the increased number of deaths in Trasylol patients could have been due to chance.
  • Health Canada's review of the BART study revealed that Trasylol prolongs certain measures of blood clotting time differently than other drugs. This effect, if not recognized, can affect how blood clotting is managed during surgery in ways that can increase the risk of blood clots and death.

New Safety Measures:

As noted above, Health Canada has worked closely with Bayer to develop new safety and risk management measures to address information identified in Health Canada's review. Strong warnings, in the form of a Boxed Warning, have been added to the product label emphasizing that Trasylol should only be used as authorized. Physicians should be aware of Trasylol's effect on certain measures of blood clotting time relative to other drugs and adhere to the recommended procedures for the management of blood clotting. Information has also been added to the Boxed Warning on the risk of abnormal kidney function.

Health Canada has also requested that Bayer conduct further studies to assess the safety and efficacy of Trasylol use in higher risk patients undergoing more complex cardiac surgeries.

Health Canada will continue to actively monitor Trasylol safety. Canadians can be confident that should new safety information emerge, Health Canada will take appropriate action and keep health professionals and Canadians informed.

Additional Information:

Additional information, including a letter sent to health professionals and a letter to the public with detailed information on the changes to the prescribing information, is available on the Health Canada website. (http://www.hc-sc.gc.ca/dhp-mps/medeff/res/eap-gce_trasylol-eng.php)

Egalement disponible en francais

Contact Information

  • Media Inquiries:
    Health Canada
    (613) 957-2983

    Public Inquiries:
    (613) 957-2991
    1-866 225-0709