February 29, 2008

 

Source of blood thinner contamination in US may have come from China

 

 

A component of a blood thinner drug which sickened hundreds of patients in the US may have come from Chinese slaughterhouses, according to a New York Times report.

 

The paper has reported that about 400 people have suffered serious complications after receiving the blood-thinner heparin. Investigators are checking whether the drug, made from pig intestines from China, could have been contaminated.

 

Investigators are examining the records of a factory supplying the active ingredient to Baxter International , which earlier this month halted heparin sales after reports of injuries and four deaths.

 

Heparin is widely used in cardiovascular surgery and dialysis.

 

Changzhou SPL, the factory owner, told the newspaper its supply chain is safe and that it buys raw material from only two reputable wholesalers, and audits about a dozen other suppliers.

 

However, US reports claimed that increasingly, raw heparin material are sourced from small village workshops which are unregulated and unsanitary. Wholesalers bought pig intestines from small factories without checking on their facilities, the reports added.

 

The authorities have not determined the source of the problem and Baxter also gets some of its ingredients from a plant in Wisconsin. Neither SPL nor Baxter has been accused of doing anything wrong.

 

However, SPL's plant in Changzhou was certified for exports to the US even though neither government had inspected it. The plant has been exporting heparin to Baxter since 2004.

 

China's State Food and Drug Administration said it had not inspected the S.P.L. factory because as it is not a drug manufacturer but a producer of chemical ingredients.

 

It is believed that as much as 70 percent of China's crude heparin comes from small factories in poor villages.