Aprotinin Sales Suspended by China
China recently suspended the sale and use of Trasylol® (aprotinin), used to control bleeding during heart surgery, after adverse reactions were reported abroad.
"According to statistics from the National Center for Adverse Drug Reaction (ADR) 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.
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 (CABG) 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.
Bayer has 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, but the drug had not been imported and no injections from Bayer had been sold in China.
Reference:
"China suspends sales, use of post-surgical drug aprotinin," People's Daily Online, December 2007.
