At the end of January Baxter Healthcare issued a voluntary recall of specific batches of their heparin products due to reports of adverse events. On Wednesday the U.S. Food and Drug Administration announced that test had revealed a "heparin-like contaminant in heparin blood-thinning products made by Baxter Healthcare Corp."
"While the FDA has not determined the root cause of the adverse events, we have found a heparin-like compound, which is not heparin, present in some of the active pharmaceutical ingredients produced by Scientific Protein Laboratories," said Dr. Janet Woodcock, acting director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research.
Joint testing by the FDA, Baxter and several university laboratories have established that all the contaminated heparin came from Scientific Protein Laboratories, of Waunakee, Wisc., and its Changzhou SPL plant in Changzhou City, China who was Baxter's main supplier of heparin.
The FDA is reporting that it has received 785 reports of adverse reactions associated with Baxter's heparin most of which have occurred in hemodialysis centers with patients that received a "bolus" dose which is a high dose administered over a short period of time.
While the contaminant has been found, the FDA has not established with complete certainty that it is responsible for the reported adverse events but is actively pursuing the theory as a possibility while not discounting other possibilities.
[Source: MedlinePlus]
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» Heparin Contamination Deliberate from PharmaGazette
We've been following the heparin contamination story for a while now. We first reported that Baxter had voluntarily recalled specific batches of the drug, then followed that up with the story of how the contaminated heparin was causing allergic rea... [Read More]
Tracked on: May 3, 2008 9:38 PM | Permalink to Trackback