Heparin Investigated by U.S. Health Officials

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Heparin Use Linked to Deaths in the U.S. On March 5, 2008, U.S. Health Officials announced the discovery of a contaminant in Baxter's Heparin that may be linked to more than a dozen deaths in the United States. FDA investigators found a "heparin like compound – that is not heparin" – present in some of the active pharmaceutical ingredients. The FDA is unsure at this time whether the Heparin contamination was accidental or deliberate. Likewise, it is not clear if the Heparin contamination was introduced in the company’s plant in China or in Baxter's plant in Wisconsin.

Heparin Facilities Not Inspected. The FDA has come under fire from Congress because it failed to inspect the Chinese facility that produced the Heparin (Changzhou SPL) before allowing it to ship the drug to the United States. Our investigation has not yet determined whether Baxter inspected the facility before accepting shipments of Heparin.

Heparin Associated with Adverse Effects by FDA. According to FDA Deputy Commissioner Janet Woodcock, "There is an association between the contaminant and the presence of adverse events, but it is not a direct causal link yet." Baxter is playing the blame game, saying it is now investigating the China-based supplier of Heparin. "Either the problem lies further back in the supply chain, somewhere before the material gets to the processing plant, or there's something in the processing before it comes to Baxter," stated Peter Arduini, President of Baxter's medication delivery business.

What should you do? First, if you or a family member has been given Heparin since September 2007 and experienced any unusual side effects, contact your doctor's office or hospital to find out if you received Baxter's Heparin. If you received Heparin and experienced any side effects, you should also contact John Evans or Megan Faust at Specter Specter Evans & Manogue, P.C. by using the form below.