A contaminated blood thinner from China was found in drug supplies in 11 countries. Federal officials have discovered a clear link between the contaminant and severe reactions now associated with 81 deaths in the United States. The contaminant was found in the drug heparin. Dr. Janet Woodcock, director of the Food and Drug Administration’s drug center, said that German regulators uncovered a cluster of illnesses among dialysis patients who took contaminated heparin. Dr. Woodcock, who said Chinese officials had conceded that heparin produced in their country contained a contaminant though they say it was not connected to the illnesses, observed:
Heparin should not be contaminated, regardless of whether or not that contamination caused acute adverse events. We are fairly confident based on the biological information that we have had that this contaminant is capable of triggering these adverse reactions.
The dispute is a sign of growing tensions between China and the United States over the safety of Chinese imports. China has in recent years exported poisonous toothpaste, lead-painted toys, toxic pet food, tainted fish and now, contaminated medicine. We have written on the problems relating to heparin in earlier issues of the Report and also in this issue.
The contaminant, identified as oversulfated chondroitin sulfate, a cheaper substance, slipped through the usual testing and was recognized only after more sophisticated tests were used. The FDA has identified 12 Chinese companies that have supplied contaminated heparin to 11 countries — Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. According to Deborah Autor, director of compliance at the FDA’s drug center, the agency did not know the original source of all the contamination or the points in the supply chain at which it was added. Officials have discovered heparin lots that included the cheap fake additive manufactured as early as 2006, although a spike in illnesses associated with contaminated heparin began in November and persisted through February.
Source: New York Times
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