Chemists are reporting a major advance toward developing a safer, fully-synthetic version of heparin, the widely used blood thinner now produced from pig intestines. The U. S. Food and Drug Administration last spring linked contaminated batches of the animal-based product, imported from China, to more than 80 deaths and hundreds of allergic reactions among patients exposed to the drug for kidney dialysis and other conditions.
The purer, non-animal version could improve the drug's safety and bolster regulatory control of its manufacture, the researchers say. Scientists expect demand for heparin, which prevents blood clots, to increase in the future due to rising rates of diabetes, heart disease, and other health complications linked to sedentary lifestyles. Global heparin sales total about $4 billion annually.
"With the problems associated with contaminated heparin produced from pig tissues in China, a non-animal source of this essential drug is gaining importance," says study co-author Robert J. Linhardt. "A safer version of the drug could result in less adverse effects and fewer deaths."
Linhardt points out that processing of pig intestines to extract the raw materials is often done in small, family-run workshops in China, which supplies about 70 percent of the world's heparin. Those mom-and-pop shops often fall outside the normal supervision and regulatory control standard in the pharmaceutical industry. The lack of oversight increases the risks of heparin contamination or adulteration with harmful chemicals, viruses, or other agents, he says. MTS
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American Chemical Society