Contaminated Heparin behind the allergic reactions- FDA

Food and Drug Administration has come out with a statement that the agency has found a link between Baxter International Inc.'s (BAX) contaminated blood-thinner heparin and hundreds of reported allergic reactions.

Chinese officials had said that the heparin contamination problem was not linked to the allergic reactions.

"The over-sulfated chondroitin cannot be the root cause," said Jin, deputy director general of China's National Institute for the Control of Pharmaceutical and Biological Products.

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.

"We have data in the test tube as well as animal data that show this contaminant can trigger events that would lead to these types of reactions," said Janet Woodcock, director of the Food and Drug Administration's Center for Drug Evaluation and Research. "That doesn't tell us the whole story. But it establishes a link."

From January 2007 through March 2008, the FDA had received 131 reports of deaths associated with heparin made by Baxter and other companies. Of the 131 deaths, 81 have been linked to an allergic reaction.

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.

Difficulty in breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure are few reactions that are developed in people who have been injected with contaminated drug.

In January, Baxter had voluntarily recalled nine lots of its heparin sodium injection in 1,000-unit vials, after reports of adverse reactions.

FDA 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.

The process of chemically manipulating chondroitin sulfate is far cheaper than getting raw heparin from pig intestines.

The active ingredient was supplied by Scientific Protein Laboratories LLC of Waunakee, Wis., which has a facility in China known as Changzhou SPL, from where the contaminant has originated.

The Food and Drug Administration had warned Changzhou SPL that the company does not have adequate systems for ensuring the safety and purity of the raw materials.

FDA said if the company does not mend its ways, any new applications listing the company as the manufacturer of any active pharmaceutical ingredient will be rejected.

Germany has also reported the contaminant and recalled batches of heparin after some patient illnesses.

FDA officials said batches of contaminated heparin found outside the U.S. have been linked to 10 Chinese- based suppliers.

Baxter shares lost 33 cents, or 0.5%, to close down at $60.95.