Following reports of serious allergic-type hypersensitivity reactions and cases of severe hypotension in association with the use of intravenous bolus doses of heparin sodium for injection, FDA identified a contaminant, in heparin sourced from pigs raised in China. More recently, questions have been raised concerning the potential risk to recipients of products where heparin may have been used in manufacturing or is present in the final product. These products include plasma-derived clotting factors, including United States licensed Antihemophilic factor (Factor VIII), Factor Nine complex concentrate, and other plasma-derived products such as immune globulins and albumin.
In response to these questions, FDA contacted manufacturers of plasma-derived products to find out what measures they were taking to reduce or eliminate potential risks of exposure to contaminated heparin. Based on the information received, FDA believes the risk of adverse reactions due to contaminated heparin to patients who receive US licensed plasma-derived products is likely to be extremely small.
- All heparin currently used for therapeutic treatment and manufacturing is tested for the contaminant, oversulfated chondroitin sulfate using sensitive FDA developed assays.
- Plasma derivative manufacturers reported one or more of the following:
- heparin was not used in their products
- heparin was used in early stages of manufacture and was not present in the final product
- heparin used in manufacturing and in small amounts in the final product was tested and found not to be contaminated
- where small amounts of heparin are in the final product, there have been no reports of an increase in allergic reactions
Importantly, the amount of heparin received by patients who had adverse events is much greater than the amount in plasma-derivative products.
More information about FDA’s initiatives to assess and mitigate the risk of contaminated heparin can be found on the Heparin Information page.