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FDA investigates heparin deaths

The US FDA is investigating the deaths of two patients at a hospital in Delaware, who were given a brand of heparin sold by Baxter

The US Food and Drug Administration (FDA) is investigating the deaths of two patients at a hospital in Delaware, who were given a brand of heparin sold by Baxter.

Officials at Beebe Medical Centre in Lewes, Delaware, reported that three patients suffered adverse reactions after being given the drug last week. Two of the patients died at the weekend; one remains hospitalised; and all three suffered cerebal haemorrhages.

Wallace Hudson, a spokesperson for the medical centre, said, "We are not pointing fingers at Baxter… We don't know what's going on, but heparin is the only commonality that we were able to see ourselves." The medical centre has since suspended use of all heparin products.

Both Baxter and the FDA have sent teams of investigators to look into the matter. The FDA have stated that "this appears to be an isolated incident". Likewise, Baxter commented that there had been no similar reports of adverse reactions from other institutions. Spokesperson Erin Gardiner said: "At this point, it is premature to speculate on the relationship, if any between the reactions… and our products," she said.

The heparin used by these patients is in pre-mixed bags and is not the same as the product sold in vials that was part of a global recall by Baxter last year. The recalled supply of heparin contained the contaminant oversulphated chondroitin sulphate from China. The heparin used in Delaware is thought to come from a North American source.

12th May 2009

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