- The Washington Times - Tuesday, April 22, 2008

From combined dispatches

The Chinese manufacturer of an ingredient in the blood thinner heparin does not have adequate systems for ensuring that the raw materials it uses are safe and that any impurities are removed, the Food and Drug Administration said yesterday.

The FDA released a warning letter to Changzhou SPL Co. hours after Chinese officials voiced doubts that a contaminant identified in heparin caused severe allergic reactions in hundreds of U.S. patients.

Changzhou, the FDA said, had “significant deviations” from good manufacturing processes. Until it complies, the agency will recommend disapproval of any new applications listing the company as the manufacturer of any active pharmaceutical ingredient.

Baxter International, which sold about half the heparin used in the U.S., announced a recall in January.

The FDA has counted 62 deaths from allergic-style reactions that were associated with recalled heparin batches. The FDA can’t say for sure what caused the reactions, but the chief suspect is a contaminant that the agency discovered in supplies of raw heparin coming from China.

Raw heparin is derived from pig intestines, often processed by small, unregistered workshops in China. Heparin is commonly used before certain types of surgery to prevent dangerous blood clots. Kidney patients also take it before undergoing dialysis.

The raw ingredient for Baxter’s recalled heparin came from Wisconsin-based Scientific Protein Laboratories, which in turn owns a Chinese factory — Changzhou SPL — and buys additional raw heparin from other Chinese suppliers.

The company said it regretted the FDA’s decision and that it did not believe the warning letter reflected Changzhou SPL’s actual state of compliance with good manufacturing practices.

At an embassy news conference, Chinese officials said the problems linked to heparin could have occurred in the United States, or that chronic conditions in some patients led to severe reactions.

They plan to visit a Baxter plant in Cherry Hill, N.J., for a better look at heparin’s development. They also hope to take back samples for their probe.

“When you see it, then you believe it,” said Jin Shaohong, the deputy director general for the National Institute for the Control of Pharmaceutical and Biological Products in China.

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