Key result
Intravenous heparin and higher OSCS concentrations correlate with rapid adverse events, ~75% occurring within 10 minutes.
Why the study?
The FDA received reports of heparin-associated allergic-type adverse events linked to a contaminant, oversulfated chondroitin sulfate, requiring characterization of clinical effects.
Observational (n=574)
Intravenous administration of OSCS-contaminated heparin is associated with a rapid onset of hypersensitivity adverse events, highlighting the importance of monitoring and regulatory oversight of the heparin drug supply.
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AERS reports associate OSCS with allergic-type AEs; hypothesis-generating and should not yet change practice.
McMahon et al. (2010) conducted an observational in Heparin-associated adverse events (n=574). Heparin contaminated with oversulfated chondroitin sulfate (OSCS) vs. Low-to-absent OSCS concentration lots was evaluated on Adverse events, mortality, and time-to-event. Intravenous administration of heparin and higher OSCS concentration correlated with a more rapid onset of adverse events, with nearly 75% of IV cases occurring within 10 minutes.
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