Apr 21, 2008 2:55 pm US/Central
FDA: Chinese Heparin Ingredient Unsafe
WASHINGTON (AP) ―
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Deputy Director-General National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) Jin Shaohong, speaks during a briefing on the drug Heparin at the Chinese Embassy in Washington, DC, April 21, 2008.
Jim Watson/Getty Images
The Food and Drug Administration told the Chinese manufacturer of a Heparin ingredient that it does not have adequate systems for ensuring that the raw materials it uses are safe and that any impurities are removed.
The FDA released a warning letter Monday to Changzhou SPL Co., hours after Chinese officials voiced doubts that a contaminant identified in the blood thinner heparin caused severe allergic reactions in hundreds of U.S. patients.
The FDA told Changzhou that it 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.
Meanwhile, Chinese officials voiced doubts Monday that a contaminant identified in the blood thinner heparin was the root cause of severe allergic reactions in hundreds of Americans.
The officials suggested at an embassy news conference that the problem with the drug could have occurred in the United States. They said they planned to visit a Baxter International plant in New Jersey to get a better picture of how the finished product is manufactured. It was unclear if the offer to visit the plant had been rescinded.
"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.
Heparin is derived from a mucus obtained from pig intestines and other animal tissues, often processed by small, unregistered workshops in China. Scientific Protein Laboratories owns a Chinese factory - Changzhou SPL - and buys additional raw heparin from other Chinese suppliers.
The Chinese officials said Changzhou SPL, the manufacturer of the heparin ingredient, was managed and overseen by a manager from Scientific Protein Laboratories' headquarters in Wisconsin, and the manufacturing processes and quality control was all provided by SPL's headquarters.
The Food and Drug Administration says 62 deaths are associated with allergic-style reactions to contaminated batches of heparin. 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.
The Food and Drug Administration has told the Chinese manufacturer of a heparin ingredient that it does not have adequate systems for ensuring that the raw materials it uses are safe and that any impurities are removed.
The FDA released a warning letter Monday to Changzhou SPL Co., hours after Chinese officials voiced doubts that a contaminant identified in the blood thinner heparin caused severe allergic reactions in hundreds of U.S. patients.
The FDA told Changzhou SPL that it 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.
(© 2009 The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.)
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