[Contaminated heparins].
In January 2008, following the detection of severe allergic reaction, several batches of heparins were removed from the United-States market. Although less dramatic, comparable side effects were also reported in Germany but not in France despite the fact that low-weight heparins, obtained from contaminated batches of unfractionated heparins, were used to limit shortage. So far, tainted injectable heparin has been linked to over 80 deaths in the USA. Analyses demonstrated that such tainted heparins were contaminated by high levels of chondroïtin persulfate (5-20%), a cheaper hemi-synthetic product. All batches were furnished by several Chinese chemical industries, China representing 50% of all heparins produced worldwide. Thus, contamination of the heparin supply is a worldwide problem. Following this event, the efficiency of the quality insurance, particularly analytical controls before proceeding, remains questionable. The strict respect of the pharmaceutical chain is urgently required to avoid any kind of quality problem in the future.
UMR 176, section de recherche, institut Curie, 26, rue d'Ulm, 75248 Paris cedex 05, France. claude.monneret@curie.fr
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D000925:Anticoagulants / Q000009:adverse effects* / Q000032:analysis*; D002681:China; D002809:Chondroitin Sulfates / Q000032:analysis; D004340:Drug Contamination / Q000706:statistics & numerical data*; D004345:Drug Industry / Q000592:standards; D006493:Heparin / Q000009:adverse effects* / Q000032:analysis*; D006801:Humans; D014481:United States
D000925:Anticoagulants; D006493:Heparin; D002809:Chondroitin Sulfates
Les héparines contaminées.