Bayer pulls its anti-clotting drug 'Trasylol' from market

Bayer AG, one of the world’s leading healthcare and medical product manufacturers, announced on Monday that it will temporarily stop selling its anti-clotting drug Trasylol, after a Canadian study linked the treatment to increased death rates among patients undergoing heart surgery.

Bayer decided to suspend the worldwide marketing of Trasylol (aprotinin injection) only after consulting with the German Federal Institute for Drugs and Medical Devices (BfArM), the U.S. Food and Drug Administration (FDA), Health Canada, and other health authorities.

The anti-clotting drug Trasylol used to prevent massive bleeding during coronary bypass surgery was approved by the U.S. Food and Drug Administration in 1993.

Trasylol, known generically as aprotinin, has been under medical scanner for over a year after hospital data suggested an inflated risk of death, serious kidney damage, congestive heart failure and stroke among people who received it.

The German pharmaceutical company’s yesterday’s move follows a request from the US health watchdog FDA to suspend marketing of the product in the United States, and orders from German regulators to suspend the marketing of Trasylol in Germany.

The move also comes ten days after a data safety and monitoring committee at the Ottawa Health Institute in Canada interrupted the randomized BART trial last month because experts said the drug exposed trial participants to an increased risk of death.

In the trial, the use of Bayer drug aprotinin was linked to 50 percent more deaths due to hemorrhage compared with two other antifibrinolytic agents against which it was tested. However, the trial also showed less serious bleeding among patients receiving aprotinin than either of the comparator blood-clotting drugs.

According to the Leverkusen, Germany-based drug maker, the blood-clotting injection will be kept off the market worldwide for two months or more so preliminary results from the BART study can be assessed to determine the safety status of the drug.

“The totality of the available data continue to support a favourable risk-benefit profile for Trasylol when used according to label,” Bayer said in a statement.

The BART trial was a multi-centre triple-blind randomized controlled trial comparing three antifibrinolytic agents in high-risk cardiac surgical procedures. For the trial, the researchers enrolled 3,000 heart bypass and valve surgery patients, who were randomized to receive either aprotinin ((2 million kallikrein inhibitory unit (KIU) bolus + 2 million KIU pump prime + 2 million KIU infusion on cardiopulmonary bypass (CPB)), epsilon-aminocaproic acid (10g loading dose + 2g/hr on CPB), or tranexamic acid (30mg/kg loading dose + 2mg/kg pump prime + 16mg/kg/hr on CPB).

First approved by the FDA in 1993, Aprotinin is indicated 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.

Sales of the injectable drug in 2005 were $333 million; however, the sales dropped by 34 percent in 2006 after the 67,000-patient analysis raised new safety concerns, as per Bayer's annual reports.