Learning Center
New In Coagulation
Wednesday, June 4, 2008
Contamination of the worldwide heparin supply
Contamination of the worldwide heparin supply: resulted in a substantial increase in adverse events and an estimated 81 deaths in the US, appears to have been a deliberate act to increase profits in Chinese workshops. The contaminant oversulfated chondroitin sulfate has anticoagulant properties that mimic heparin, but at a much lower production cost--about $20/kg vs $2000/kg to produce crude heparin. Accordingly, there is speculation that the contaminant was added deliberately to increase profits for the workshops and/or consolidators that ship the crude material to Changzhou SPL, SPL Wisconsin, and other heparin [active pharmaceutical ingredient] API producers.
The FDA acted quickly once it identified the adverse events, but should the foreign drug plants have been inspected? FDA will spend $11 million this year on foreign drug plant inspections but that it would cost an additional $250 million each year to inspect every such plant every two years, which it has been suggested should be done. http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml
http://www.medscape.com/viewarticle/573789
Fergusson D, et al "A comparison of aprotinin and lysine analogues in high-risk cardiac surgery" N Engl J Med 2008; 358: DOI: 10.1056/NEJMoa0802395.
New England Journal of Medicine reported: , the 30-day all-cause death rate in the aprotinin group was 6%, versus 3.9% with tranexamic acid (Cyklokapron) and 4% with aminocaproic acid (Amicar). Trasylol is an antifibrinolytic drug approved to reduce blood loss during surgery and the need for blood transfusion in certain patient undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery. Antifibrinolyitc drugs help slow the breakdown of blood clots and subsequent excessive bleeding.
- The study found more deaths in patients receiving the hemostasis drug aprotinin (Trasylol) during cardiac surgery than with other similar agents.
- Aprotinin was not significantly more effective in preventing excessive bleeding than the other drugs.
- Aprotinin has been withdrawn from the market worldwide.
Donna Castellone
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