The offending component of heparin that is blamed for scores of deaths in the US has been traced to Changzhou SPL, a company registered in China as a manufacturer of chemicals, not drugs.
The Wall Street Journal reported on March 10, 2008, that another company in China, Shenzhen Hepalink, provides the active ingredient for heparin used in kidney dialysis and other “large dose” applications. The report states that Shenzhen Hepalink follows strict guidelines for protecting the ingredient from contamination. The implication is that that patients have no fears if they are taking heparin in large quantities because the medicine came from a reliable source.
The offending active ingredient is “oversulfated chondroitin sulfate,” which originates in the cartilage of animals. Medpage gives an easy-read explanation of how the compound triggers inflammation in two separate pathways, causing death and how it was possible for screening methods not to identify the substance.
In summary, the compound is a “long sugar” molecule with a chemical structure that resembles the heparin so closely that standard tests did not detect it.
Screening practices are quickly being modified so that future adulterants will be more readily detected and kept from distribution.
The interesting point being made by scientists is that it is highly unlikely that the contaminant developed naturally. Instead, it seems to have been deliberately manufactured and shipped for insertion into the heparin compound.
More information about this development:
UPI: Germany recalls heparin made with an active ingredient from China
News about the heparin probe from Associated Press WorldStream; recalls in 6 countries
Q&A by FDA on heparin sodium injections from Baxter
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