US Investigating Chinese Factory Supposedly Linked To Faulty Drug Heparin

Greg Webb

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A Chinese factory, which has not been inspected by the Food and Drug Administration, is the source for the active ingredient of heparin, a drug used widely in dialysis, heart surgery and chronic care in hospitals. Heparin is a blood-thinning drug whose production was suspended after 350 patients reported bad side effects from it. Late last year, heparin was recalled after many pediatric dialysis patients suffered allergic reactions to the drug. The FDA reports it was making plans to inspect the factory in China and its finishing plant in New Jersey as soon as possible. They also state that it has yet to be proven that the Chinese factory was the source of the problem that led to the increase in patients' reports of problems with the drug. http://www.nytimes.com/2008/02/14/business/worldbusiness/14heparin.html?_r=1&ref=health&oref=slogin

The Government Accountability Office recently reported that at the FDA's current inspection pace, it would take them thirteen years to investigate every foreign drug plant that exports to the United States. They also found the FDA's computer systems deficient, meaning they had little idea what factories had been approved to export to the United States. Chinese officials have promised to strengthen their oversight of the production and exporting of foods, drugs and medical devices. Baxter International, the company in question, manufactures half the supply of heparin, so with the company's suspension of production, shortages are expected. http://www.nytimes.com/2008/02/14/business/worldbusiness/14heparin.html?_r=1&ref=health&oref=slogin