BEIJING, Dec. 18 (Xinhua) -- 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.