Researchers have found a contaminent in samples of recalled Heparin that are chemically similar to the drug but may explain the adverse reactions that have been reported. The FDA is unsure how the contaminant got into the Heparin. Initial testing did not reveal the contamination due to the similarity.
High-tech testing by Baxter and other groups uncovered a heparin-like compound in batches of the problem drug – a substance not found in batches of problem-free heparin.
The contaminant accounted for between 5 percent and 20 percent of some of the samples tested, what FDA’s Woodcock called “significant quantities.”
At those amounts, batches of heparin should have been flagged as subpotent in Baxter’s routine quality tests – but they didn’t, because the contaminant is so chemically close to real heparin that standard testing couldn’t tell the difference, Woodcock said.
Baxter said the contamination was a naturally derived chemical. The FDA is trying to determine if it was added during processing or deliberately added. Portions of the Heparin were manufactured in China, which has seen a large number of recalls in the last year. Heparin is a blood thinner used during heart surgery and kidney dialysis.