Search Continues for Source of Heparin Contamination(2)

The FDA’s investigation into the contamination of blood thinners sold by Baxter Healthcare Corporation continues. It was recently announced that investigators had identified a contaminant in approximately 5% to 20% of the heparin lots tested so far. The lingering mystery is how Baxter’s popular blood thinner became contaminated, and whether the contamination was an accident or whether it was a deliberate act.

Baxter Healthcare markets a significant portion of the heparin sold in the United States. Apparently, the raw materials utilized to manufacture the anti-clotting agent were purchased by Baxter from another American company, Scientific Protein Laboratories, LLC, which procured the crude heparin from facilities in China. Earlier reports had focused on whether the Chinese facilities that were utilized had met all required health standards, especially after reports that the FDA investigators had failed to inspect such facilities due to confusion over the name of the plant. So far, the FDA has received 785 reports of adverse events linked to heparin. These reactions to the contaminated blood thinner products include difficulty breathing, nausea, vomiting, excessive sweating, and significant drops in blood pressure that can result in shock and other serious complications. The true incidence of such adverse reactions, however, may never be known since the FDA only receives adverse event reports for a very small percentage of such complications, and it is likely that a number of patients who suffered such reactions prior to discovery of the contamination were likely told that their condition was due to other causes. Not surprisingly, the manfacturers are denying any culpability and are not yet even agreeing that there is a problem with the product.

A March 6, 2008, CNN report quoted the manufacturer:

“It is premature to conclude that the heparin active pharmaceutical ingredient sourced from China and provided by SPL to Baxter is responsible for these adverse events.” CNN also reported that the manufacturer contends that “its voluntary recall” of the contaminated heparin was being made only “as a precaution.”