Heparin contaminant identified by China

China’s State Food and Drug Administration (SFDA) has identified the contaminant present in Baxter’s Heparin to be Hyper-sulphated Chondroitin Sulphate.

The compound Chondroitin Sulphate occurs naturally and is used as a dietary supplement to treat joint pain. But the over-sulphated version of the compound is not that common.

Heparin is commonly used in dialysis to prevent clotting of the blood when it circulates in a dialysis machine. It makes the blood thinner and thus reduces the loss of the blood during dialysis. Anemic patients can’t afford this blood loss as it could prove fatal for them.

The most common reactions that are developed are difficulty in breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure. All these can prove fatal and thus further analysis was done on the effect of this drug.

China and U.S. have been locking horns over various health related issues in the recent past. U.S. has been continuously stating its concerns over the practices prevalent in China. In this case, FDA has received 785 reports of infections by Baxter produced heparin, including 19 deaths in patients treated with some brand of heparin.

A probe into the matter linked the source of contamination to a Chinese plant, where an essential ingredient of the drug was manufactured. In January, Baxter had voluntarily recalled nine lots of its heparin sodium injection in 1,000-unit vials, after reports of adverse reactions.

The FDA is now probing that whether this compound is the reason for the deaths and other problems reported in the United States.

"We cannot rule in or out whether this was accidentally or deliberately introduced into the product," Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research said. "We are investigating how it got in."

The process of chemically manipulating chondroitin sulfate is far cheaper than getting raw heparin from pig intestines. Thus increasing profit might have been the motive behind the contamination.

However, SFDA unlike FDA is not certain whether the ingredient is the reason behind the adverse reactions that heparin products had caused in the United States.

Though the administration agreed that the contaminant originated from the supplier in Changzhou, east China's Jiangsu Province, but it wants to conduct few tests before confirming that this was the cause of deaths in U.S.

“Since the relevance of the ingredient to the allergic reactions was not immediately determinable, the SFDA was organizing experts for further investigations, and the result would be made known to the public,” the SFDA spokesman said.