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May 22, 2006
Volume 84, Number 21
p. 11

Drug Safety

Faulty Drug Kills Five People In China

Jean-François Tremblay

At least five people have died from kidney failure in the southern Chinese province of Guangdong after being injected with a defective drug.

The problem drug is armillarisin A, used to treat gall bladder and gastric conditions. A preliminary investigation by China's State Food & Drug Administration found that the drug's manufacturer, the state-owned Qiqihar No. 2 Pharmaceutical Co., based in the northeast province of Heilongjiang, had used toxic diethylene glycol as an ingredient instead of the more expensive propylene glycol.

The company had obtained the diethylene glycol from Wang Guiping, a man impersonating an approved supplier. For reasons unknown, Qiqihar did not check the material before using it to produce 1.8 million faulty doses, SFDA says.

Those who died had been patients at Sun Yat-Sen University Hospital in Guangzhou. At least eight other people who received the drug survived, although Hong Kong's South China Morning Post reports that more fatalities may have occurred.

The pharmaceutical plant, which employs 300 people, was closed, and Chinese police are reportedly holding Wang and several Qiqihar employees. Vice Premier Wu Yi, one of China's most respected leaders, is personally spurring the inquiry, SFDA says.

According to a foreign executive who is familiar with China's drug industry but asks not to be identified, most Chinese plants do not comply with the current Good Manufacturing Practices followed in the U.S. He says SFDA has been attempting to correct the situation. But after requiring cGMP adherence several years ago, the agency had to extend deadlines and water down requirements because too few plants could conform, the executive says.

Chemical & Engineering News
ISSN 0009-2347
Copyright © 2010 American Chemical Society