WSJ: Product Variations Found in Baxter’s Chinese-Made Heparin
Buried deep in today’s WSJ update of the investigation into allergic reactions associated with Baxter Healthcare’s heparin (“Baxter Rival APP Steps in Quickly to Supply Heparin”) is an indication that irregular heparin batches came from a supplier’s Chinese plant (Scientific Protein’s Changzhou SPL).
[Y]esterday Baxter disclosed that the variations from standard product occurred in the Chinese-made batches.
There is otherwise little information regarding the nature or source of variations in Baxter’s affected heparin lots that may have caused the adverse reactions, and the WSJ story implies that Baxter is tight lipped about further details. The Pathophilia blog has speculated that inadequate heat treatment during heparin manufacture may have resulted in higher-than-trace amounts of bacterial endotoxin in the product.
Numerous news stories reveal that Scientific Protein’s Changzhou plant had not been inspected by the FDA, because the name of the plant was confused with that of another Chinese facility, which the FDA had reportedly already inspected. Baxter claims that it inspected the Changzhou facility approximately 6 months ago, according to the WSJ, and an FDA team plans to conduct an on-site inspection this week. The WSJ also reports that the FDA is inspecting a Baxter facility in Cherry Hill, NJ, and Scientific Protein’s plant in Wisconsin.
Meanwhile, rival heparin maker APP of Schaumburg, IL, has moved to fill the void created by Baxter’s heparin-lot withdrawals and is likely to capitalize on the desire of hospital and dialysis-center administrators to avoid Baxter’s heparin altogether. Some of the active ingredient in APP’s heparin is manufactured at a Chinese facility, which has been inspected by the FDA, according to the WSJ.