Heparin Contaminant Identified

The contaminant in a tainted blood-thinning drug China exported to the U.S. has been identified. The substance, hypersulfated chondroitin sulfate, mimics the blood thinner in standard safety tests and may have been deliberately substituted to boost middlemen’s profits. “If I had to guess, I would say this is a lot like the pet food case,” said Larry D. Sasich, chairman of pharmacy practice at the LECOM School of Pharmacy. From Los Angeles Times:

A compound related to a common nutritional supplement has been identified as the contaminant in a blood-thinning drug imported from China that sickened hundreds of frail patients in the U.S. and is suspected in a number of deaths, federal officials said Wednesday.

The substance mimics the real drug — heparin — in standard safety tests and may have been deliberately substituted for the genuine compound somewhere along the line to boost middlemen’s profits. It could also have been added through a mishap or some kind of misguided experiment. Because of difficulties in back-checking, it’s unclear whether Food and Drug Administration officials will ever know for sure…

The FDA is chronically short of resources to meet its mandate to oversee a vast array of drugs, medical devices, and processed and natural foods. Inspections of foreign producers in particular are infrequent. And China has been difficult territory for U.S. regulators.

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