November, 5 , 2007, US FDA and Health Canada the American's and Canadian equivalent to the Saudi Food and Drug Authority (SFDA) , announced that at the request of Health Canada and US FDA , the manufacturer Bayer Inc. has temporarily suspended marketing of the drug Trasylol (Aprotinin) pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.

Trasylol (Aprotinin) is drug used to control bleeding during heart surgery and reduce the need for blood transfusion.

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.

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

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.

Actions that Healthcare Professionals and Public Should Follow:

-The authorized indication for Trasylol® is restricted to those patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft (CABG) surgery who are at increased risk for blood loss and blood transfusion.

-Trasylol® administration may cause fatal and nonfatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with an initial (test) dose as well as with any of the components of the dose regimen. Fatal reactions have also occurred in situations where the initial (test) dose was tolerated. As a result, Trasylol® should only be administered in operative settings where cardiopulmonary bypass can be rapidly initiated. The risk for anaphylactic or anaphylactoid reactions is increased among patients with prior aprotinin exposure, and a history of any prior aprotinin exposure must be sought prior to Trasylol® administration. The risk for a fatal reaction appears to be greater upon re-exposure within 12 months of the most recent prior aprotinin exposure. As a result, administration of Trasylol® to patients with a known or suspected previous aprotinin exposure during the last 12 months is contraindicated.

-Trasylol® administration increases the risk of renal dysfunction and may increase the need for dialysis in the perioperative period. This risk may be especially increased for patients with pre-existing renal impairment or those who receive aminoglycoside antibiotics or drugs that alter renal function.

Report Adverse Drug Reactions to the Saudi FDA

The public and health professionals are encouraged to report adverse drug reactions the National Pharmacovigilance Center on the Internet at