Heparin Sodium Injection - Background Information
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Heparin Contamination Overview
Prior to 2008, Baxter was one of several manufacturers who produced and supplied heparin. Heparin is a commonly used anticoagulant (frequently called a blood thinner). One of the most common therapies in the United States, it has been used for more than 70 years and is administered in a wide variety of clinical and surgical settings.
In early 2008, Baxter doctors who routinely monitor safety information related to the company's products detected an unusual increase in allergic-type reactions in the United States associated with heparin. Patient safety is Baxter's number one priority, so Baxter initiated voluntary recalls, suspended the manufacture of heparin vials, and launched an investigation to understand the cause of the reactions.
Baxter scientists conducted tests and identified a contaminant, over-sulfated chondroitin sulfate (OSCS). The contaminant had been chemically modified and was therefore so heparin-like in nature that it wasn't detected through standard, globally-recognized quality tests that Baxter and its supplier performed on every batch. OSCS was intentionally introduced into heparin made by Baxter during the early points in the product's supply chain.
Once the contaminant was identified and testing protocols were shared with other manufacturers globally, more than a dozen other companies in nearly a dozen countries issued recalls, all with common supply points.
According to a study published in the December 3, 2008 New England Journal of Medicine, the Centers for Disease Control and Prevention's (CDC) epidemiologic investigation found that heparin contaminated with over-sulfated chondroitin sulfate (OSCS) was linked to adverse reactions. Adverse reactions to the OSCS-contaminated heparin were often characterized by hypotension, nausea, and shortness of breath occurring within 30 minutes after administration. This allergic-type reaction was temporary.
Baxter has made significant changes to its supply chain, streamlining processes and introducing additional safeguards to reduce the risk of adulteration. The company has also been actively involved in industry-wide initiatives to protect the medical supply chain and to ultimately protect patients from contaminated products.
Baxter has not recommercialized vials of heparin since 2008 and has since sold the division that included heparin and other multisource (generic medications manufactured by multiple manufacturers) products.
Congressional Testimony - April 29, 2008
- Baxter CEO Bob Parkinson testimony before Congress - Opening Comments (PDF)
- Baxter CEO Bob Parkinson testimony before Congress - Complete Testimony (PDF)
- Statement of David G. Strunce President and Chief Executive Officer Scientific Protein Laboratories LLC (Published with permission of SPL) (PDF)