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Heparin is Safe, Secretary Leavitt Says | cialis online

Heparin is Safe, Secretary Leavitt Says

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Health and Human Services (HHS) Secretary Micheal Leavitt says Heparin from China is now safe, even though the Chinese have obstructed the Food & Drug Administration (FDA) investigation into tainted heparin. The Chinese have not allowed FDA inspectors access to that country’s entire heparin supply chain, and won’t even acknowledge that a counterfeit ingredient found in defective heparin ingredients made in China had anything to do with hundreds of serious reactions and 81 deaths in the US.

Leavitt told the Associated Press yesterday that the FDA has implemented tougher testing and other controls to insure the quality of the heparin supply. “We have put in place processes that we believe can ensure the safety of the heparin supply within the United States,” he said.

Leavitt also said that he believed the US and China would soon resolve a dispute over the FDA’s investigation. The Chinese so far have refused to acknowledge that chondroitin sulfate had anything to do with the heparin reactions, despite scientific studies done in the US that demonstrated the chemical could do so. The Chinese have also not allowed the FDA access to the entire heparin supply chain. Though it inspected the facility that made tainted heparin ingredients in March, the FDA has been barred from having complete access to some Chinese workshops that supplied that factory with raw heparin ingredients, as well as records and workers.

The FDA, which falls under Leavitt’s authority, has been rightly criticized for its role in the heparin debacle. Shortly after the first heparin recall was issued, it was learned that the FDA had never inspected the Chinese plant where Baxter obtained raw heparin. Apparently, an error in the agency’s compute database had made it appear as though inspectors had checked out the facility. Once the FDA did finally inspect the factory, it found a host of problems which it detailed in a warning letter. The FDA also banned the plant from importing to the US until corrections are made.

Earlier this year, 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. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in a 12 countries. In the US, other heparin suppliers have issued precautionary recalls, and some medical devices makers have also recalled heparin-coated 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. Last month, FDA Commissioner Andrew von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.”

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