Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008

Abstract

Intravenous administration and a higher OSCS concentration appeared to correlate with a more rapid onset of event. The FDA continues to monitor AEs associated with heparin use and has taken appropriate regulatory action to ensure a safe heparin drug supply.

Combining 1H NMR spectroscopy and multivariate regression techniques to quantitatively determine falsification of porcine heparin with bovine species

“…In this regard the crucial anticoagulant drug heparin is a representative example due to several cases of heparin adulteration leading to numerous adverse reactions and death in 2007-2008 [47]. This has demonstrated that necessity of the development of new method for analysis of heparin origin.…”

A critical review on the use of modern sophisticated hyphenated tools in the characterization of impurities and degradation products

“…Another example is that of polymeric DPs in aminopencillins that have been attributed to cause allergenicity and not the drugs themselves [6,7]. The most recent case is the presence of oversulfated chondroitin sulfate in heparin samples that caused allergenic reactions and over 100 deaths [8]. A subset of IMPs and DPs even carry potential for genotoxicity, which pose an additional safety concern, because these molecules can cause genetic mutations, chromosomal breaks, and/or chromosomal rearrangements, leading to significant risk for carcinogenicity or other toxic effects [9].…”

Надлежащая Практика Планирования Доклинических И Клинических Исследований Нефракционированных И Низкомолекулярных Гепаринов В России Как Основа Безопасности И Эффективности Антикоагулянтной Терапии

“…Ïîìèìî ñïåöèôè÷åñêîãî àíòèêîàãóëÿíòíîãî äåéñò-âèÿ, ÷ðåçâû÷àéíî âàaeíîé ïðîáëåìîé ÿâëÿåòñÿ îáåñïå-÷åíèå ïðèåìëåìîãî óðîâíÿ èììóíîãåííîñòè ïðåïàðà-òîâ ãåïàðèíà, êîòîðàÿ ìîaeåò ñòàòü ïðè÷èíîé ðàçâèòèÿ íåaeåëàòåëüíûõ ðåàêöèé (ãåïàðèí-èíäóöèðîâàííàÿ òðîìáîöèòîïåíèÿ) è ñíèaeåíèÿ ýôôåêòèâíîñòè ïðåïà-ðàòîâ ãåïàðèíà [13,15]. Èììóíîãåííîñòü îïðåäåëÿåò-ñÿ ìíîaeåñòâîì ôàêòîðîâ, ñðåäè êîòîðûõ ìîãóò áûòü âàðèàíòû ãëèêîçèëèðîâàíèÿ, êà÷åñòâåííûé è êîëè÷å-ñòâåííûé ñîñòàâ ïðèìåñåé, îñîáåííîñòè ëåêàðñòâåí-íîé ôîðìû, óñëîâèÿ åå õðàíåíèÿ è ñïîñîá ïðèìåíåíèÿ ïðåïàðàòà.…”