FDA Links Tainted Heparin To Adverse Reactions, Deaths

Washington (dbTechno) - It seems that the U.S. Food and Drug Administration has found a link between the contaminated blood-thinner heparin from Baxter International Inc., and the many adverse reactions and deaths believed to be caused by the drug.

The FDA came out on Monday and stated that they also believe the contaminant found in the Baxter heparin was used in many other heparin products around the world.

They believe that other companies in at least 10 countries sold contaminated heparin.

This all comes after Chinese officials stated on Monday that they believed the contamination of heparin was not the cause of the adverse reactions and deaths.

In a statement, Changzhou SPL and Scientific Protein Laboratories, those linked to the contaminant said “We regret FDA’s decision to send a warning letter to Changzhou SPL, and we do not believe that the warning letter reflects Changzhou SPL’s actual state of compliance with current good manufacturing practices.” Changzhou SPL believes the contaminant was introduced before it reached either company, meaning it was not their fault.

The biggest link the FDA has found in patients who received large, rapid doses of heparin. The number of adverse reactions and deaths fits the exact timetable for when the heparin began to be contaminated, right up until when it was recalled.

The FDA has received over 130 reports of death associated with heparin made by Baxter and other companies. This was from January 2007 to March 2008.