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The U.S. Food and Drug Administration said the situation "appears to be an isolated incident," agency spokeswoman Karen Riley said this afternoon.
Use of Baxter's heparin, a diluted form in pre-mixed bags used for a variety of blood thinning purposes, has been suspended by officials at Beebe Medical Center in Lewes, Del. since Friday. Adverse reactions were reported in five patients who had problems that included internal bleeding in the brain.
"We're investigating thoroughly and we have not received any similar reports of adverse events from any other hospitals regarding this widely-used product," Baxter spokeswoman Erin Gardiner said.
The heparin used in these patients is in pre-mixed bags and not the same as the product solid in vials that was part of a global recall by Baxter last year.
What's more, the heparin used by the Beebe Medical Center came from a North American-based supplier unlike the heparin Baxter said was adulterated in a China-based supply chain. The heparin used by doctors at the Beebe Medical Center is derived from active ingredient supplied by Pfizer Inc. that is sourced from North America, Baxter said.
"FDA is aware of this incident and is actively investigating, including, among other things: gathering more information about the known reported adverse events; analytical testing of Baxter heparin and components; and examining adverse events in FDA's database," FDA spokeswoman Karen Riley said. "Results of product testing to date by FDA and Baxter have not revealed any problems."
Last year, Baxter recalled heparin products that are used largely before kidney dialysis and before major surgeries such as open heart operations in the wake of a spike in the number of allergic reactions.
In those incidents, FDA officials and Baxter believe a substance known as oversulfated chondroitin sulfate was intentionally put into the product from suppliers in China. Heparin's active pharmaceutical ingredient is derived from pig intestines.
bjapsen@tribune.com
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