Heparin Contamination Deaths Counted
The US Food and Drug Administration (FDA) has just released some important statistics that reveal the number of heparin-related deaths before and after the recent recall of heparin and heparin-related products manufactured and/or distributed by Baxter International Inc. and Scientific Protein Laboratories LLC (SPL), both headquartered in Wisconsin. SPL gets its active ingredient from its own plant in China and distributes its heparin products to Baxter.
Recent tests of the product suggest a contaminant similar to heparin, but lacking the anti-clotting action of the drug, as the cause of reported adverse effects. The raw ingredients for making heparin come through an unregulated supply chain in China. The contaminant is known to cause allergic reactions and hypotension (low blood pressure) in some patients, with adverse reactions severe enough to cause death in some cases.
For the period of January 1, 2007, through March 31, 2008, there were:
- 103 deaths by any cause of patients receiving heparin
- 91 of these deaths were reported to the FDA only after January 1, 2008
- 62 of them were associated with at least one adverse reaction to the drug
- 56 of these were reported to the FDA only after January 1, 2008
- 6.9 is the average number of deaths per month where heparin was used
For the period of January 1, 2006, to December 31, 2006, there were:
- 55 deaths by any cause of patients receiving heparin
- 3 of these deaths were associated with at least one adverse reaction
- 4.6 is the average number of deaths per month where heparin was used
The heparin administered in these cases was not isolated according to manufacturer, including but not limited to Baxter and SPL.
The recall has prompted an influx of reports of heparin-related adverse reactions to the FDA. The FDA will diligently investigate each claim and keep the general public informed of its findings.
About 400,000 reports involving adverse reactions come to FDA attention each year. More than 90% of these reports come directly from the drug’s manufacturers.
Source: FDA
