Heparin Sodium Injection

Customers with questions about Baxter's U.S. vial-based heparin product recall may call the Center for One Baxter at 1-800-4-BAXTER (1-800-422-9837). Representatives are available Monday through Friday from 8 a.m. - 5 p.m. Central Daylight Time.

Heparin Situation Overview - May 21, 2008

In early January 2008, doctors in Baxter’s pharmacovigilance group, who routinely monitor safety information related to Baxter products, detected an unusual increase in allergic-type reactions associated with heparin sodium injection, a commonly used anticoagulant (frequently called a blood thinner). Patient safety is Baxter’s number one priority and the company deeply regrets the impact this situation has had on patients.

Baxter worked with the U.S. Food and Drug Administration (FDA), initiated a voluntary recall of certain dosages of heparin, temporarily suspended the manufacture of heparin, and launched an investigation to understand the cause of the reactions in January. Baxter then began observing similar reactions in other heparin vial formats. Given that Baxter had been supplying 50% of the U.S. market and a further recall of heparin could have created an immediate and severe shortage of this critical drug, Baxter and FDA determined that removal of Baxter’s heparin from the market would create more risk to the population of patients requiring heparin therapy than the increased potential for experiencing an adverse reaction. Baxter notified customers and health care professionals of this situation and provided instructions for ways to mitigate risk of adverse reactions, which had been primarily observed in dialysis, pheresis and invasive cardiac procedures. Once adequate alternative supply had been confirmed, Baxter proceeded with the recall of all of its vial-based heparin products in February in the U.S.

Baxter continued to investigate and its scientists developed new, advanced test protocols using nuclear magnetic resonance and capillary electrophoresis, which detected abnormal peaks in the crude material used to make heparin active pharmaceutical ingredient (API). Baxter scientists identified a contaminant, over-sulfated chondroitin sulfate. 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 perform on every batch of heparin. The presence of the substance in crude heparin indicates that the contaminant was introduced during the raw material stage, before it reached Baxter or its supplier, in what appears to be a deliberate scheme to adulterate a life-saving medication.

Baxter’s supplier is a U.S.-based company, Scientific Protein Laboratories, which operates one facility in Wisconsin and one in China. The raw material came from China, as most of the world's heparin API supply does, and was then processed in China or Wisconsin. The decision to source from China is based solely on supply -- the majority of the world’s supply of crude heparin comes from China, due to the large number of pigs required. Crude heparin is processed from porcine intestinal mucosa and there are insufficient supplies of this raw material in North America to meet the needs of the U.S. market.

Though Baxter was first to recall heparin because of increased adverse reactions, after the contaminant was identified and testing protocols were shared with other manufacturers globally, over a dozen other companies in nearly a dozen countries issued recalls, which linked back to certain supply points in China.

Through biological testing, Baxter scientists have shown the contaminant, over-sulfated chondroitin sulfate, can in fact trigger hypotensive reactions in animal models. Baxter is continuing its investigation to understand how and why this contaminant was introduced into the heparin supply chain. In the meantime, Baxter will not sell another vial of heparin until the company has helped to create a system in which the quality and safety of heparin is secured.

Congressional Testimony - April 29, 2008