The contaminant found in heparin was most likely introduced intentionally, according to the US Food and Drug Administration.
In a Senate hearing on April 15, FDA Commissioner Andrew von Eschenbach said the FDA suspects the contaminant, oversulfated chondroitin sulfate, was introduced to increase profits.
However, it is unclear where in the chain of production the contaminant was added and, therefore, who would be responsible.
Baxter International Inc. and Scientific Protein Laboratories Inc. (SPL), suppliers of heparin, say the contaminant was not added in their factories.
Baxter said it has been seeking access to consolidators and workshops in China that handled the crude material before it went to SPL. According to spokeswoman Erin Gardiner, Baxter has not determined how or why the contaminant was introduced.
SPL has issued a press release claiming its lack of involvement in the contamination.
The company said, “Based upon testing and reports from around the world, it is clear that the contamination occurred on a widespread basis earlier in the Chinese heparin raw material supply chain, before those materials reached Changzhou SPL and SPL.”
Baxter began recalling heparin January 17 of this year, after receiving reports of allergic reactions and deaths resulting from use of the drug. Recalls of heparin have continued since that time.
In mid-March, the FDA released the news that a contaminant was found in crude lots of heparin at a Chinese processing plant. The substance was identified as over-sulfated chondroitin sulfate, which mimics heparin and is cheaper to produce than real heparin.
Earlier this month, the FDA said a total of 62 people have died since January as a result of heparin use.
