In what seems to be a daily occurrence, more countries are announcing heparin recalls. France, Italy, and Denmark recalled the blood thinner or its ingredients. What's more, the Italian recall implicates a Chinese company supplying APP Pharmaceuticals, the only company still distributing large-dose heparin for surgery and dialysis in the U.S. after Baxter recalled its heparin products and stopped making them pending investigation.
The Italian company Opocrin said it had bought contaminated ingredient from Shenzhen Hepalink, APP's supplier. APP, however, says that Opocrin's active ingredient came from different slaughterhouses than APP's has. Plus, APP's heparin has proved contaminant-free in its own and FDA testing.
There have been no reports of adverse reactions in any of the three countries, but some batches of heparin and its active ingredient have proven contaminated or are suspected to be contaminated, according to a spokesman from the European Medicines Agency. "We presume it is the same contaminant" as the oversulfated chondroitin sulfate found in batches in the U.S., the spokesman said. Several dozen patients in Germany reported allergic reactions, and severe adverse effects were seen in hundreds in the U.S. Nineteen heparin patients have died. The FDA's investigation is ongoing.
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