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Another Heparin Warning from the FDA

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The Food & Drug Administration (FDA) has issued another heparin alert because some medical facilities still have the tainted drug in their inventories. The FDA’s reminder was prompted by reports from the California Department of Health, the FDA’s own recall monitoring, and from Baxter International Inc., the largest supplier of heparin, showing problems in the recall response. An FDA spokesperson told The Wall Street Journal that California authorities had sent a letter out on May 2 about gaps in the recall response. Inspectors checked various facilities and found recalled heparin on crash carts, in catheter labs, and even on hospital pharmacy shelves.

The findings prompted the FDA to issue an alert that read in part: “Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in one state since the recall announcement.”

The heparin problems first came to the attention of the FDA in January, when Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme – and in some cases fatal – allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

The FDA has received a lot of criticism in Congress because of the heparin scandal. Shortly after the Baxter recall, it was learned that the FDA had never inspected the Changzhou facility. The agency’s outdated computer system was blamed for that oversight. Now, the FDA is facing more criticism for not cooperating with a congressional investigation into the heparin debacle, with some lawmakers voicing frustration over the FDA’s refusal to turn over a list of Chinese heparin suppliers to investigators. At this time, the FDA is refusing to give lawmakers access to the list because it says that doing so would violate privacy agreements concerning proprietary information.

Congress is also less than pleased with what appears to be Chinese attempts to block some facets of the heparin investigation. Though it finally inspected the Changzhou facility in March, the FDA has been barred from having complete access to some Chinese workshops that supplied Changzhou with raw heparin ingredients, as well as records and workers. Since the March inspection, the agency has issued the Changzhou factory a warning letter and barred it from importing products to the US.

But despite the Chinese reluctance to open up the entire heparin supply chain to FDA inspection, the agency is allowing heparin imports from that country’s other manufacturers. The FDA didn’t issue a blanket “import alert” legally holding up all Chinese heparin pending successful testing, because it doesn’t have the legal authority to do so, FDA officials have said.

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