China's top drug watchdog on Monday suspended the sale and use of aprotinin, used to control post-surgical bleeding, after adverse reactions were reported abroad.
"According to statistics from the National Center for ADR [Adverse Drug Reaction] Monitoring, aprotinin injections could cause adverse reactions including allergy, allergic shock, palpitation, choking, breathing with difficulty, shivering, fever, sickness and vomiting," the State Food and Drug Administration (SFDA) said in a statement posted on its website.
No adverse reactions have been reported in China.
Aprotinin is used to reduce blood losses and the need for transfusions in patients undergoing a cardiopulmonary bypass in the course of coronary artery bypass graft surgery.
Following an overall safety evaluation, the SFDA concluded that the risks of the drug exceeded its benefits and that it should be taken off the market.
The decision followed the suspension last month of aprotinin-containing medicines for systemic use in the United States, Canada, Germany and Spain. Results from a randomized interim trial by the Ottawa Health Institute showed increased mortality for patients receiving aprotinin.
The German manufacturer, Bayer, subsequently decided to suspend the worldwide marketing of its aprotinin-containing medicinal products, Trasylol and Trasynin.
According to the SFDA, there were 20 enterprises in China producing aprotinin injections. The drug had not been imported and no injections from Bayer had been sold in China.
(Xinhua News Agency December 18, 2007)
