Aprotinin agents can cause serious adverse reactions

State Food and Drug Administration on November 9 release of information: the National Adverse Drug Reaction Monitoring Center monitoring, received a total of some domestic pharmaceutical production and production of aprotinin agents report cases of adverse reactions 229 cases, including cases of serious adverse reaction report 49 cases, the main adverse reaction to allergy-like reaction, anaphylactic shock, hemoglobin urine, nausea, chills, vomiting, chest tightness, difficulty in breathing, urticaria, hypotension, and so on.

State Food and Drug Administration are organizing the relevant departments and experts, on China's aprotinin in clinical use and to evaluate security issues, and will take corresponding measures.

Aprotinin is a broad-spectrum protease inhibitors, can be used to regulate heart pump (CPB) surgery caused by the body inflammatory response (SIR). SIR can activate the relevant bleeding, fibrinolysis, and inflammation system cells and body fluids. Aprotinin and through its effect on a variety of media (such as vascular-Shu, plasmin enzyme) can reduce the inflammatory response, fibrinolytic response and the formation of thrombin. Manual indications for the prevention of drug use, for the implementation of pump coronary artery bypass surgery patients to reduce bleeding during surgery, and the corresponding reduced demand for blood transfusion.

National Adverse Drug Reaction Monitoring Centre in November 2004, "Adverse Drug Reaction communications" section 7, issued a safety of the drugs information, suggesting that the drugs can cause serious adverse reactions, the proposed clinicians strictly indications , To strengthen monitoring of medication.

It is learnt that recently the U.S. Food and Drug Administration (FDA) announced that, should the FDA request, Bayer pharmaceutical companies agreed to suspend aprotinin injection (aprotinin, trade names: Trasylol) go on sale in the United States. The suspension stems from the Canadian patients with a clinical trial (BART), test results showed that the use of aprotinin in patients with increased risk of death. At present, China's market has not approved the import aprotinin drug sales.