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FDA Investigating Delaware Heparin Deaths

Tue, 05/12/2009 - 5:01am
RANDALL CHASE Associated Press Writer DOVER, Del. (AP) — The FDA said Monday that it is investigating the deaths of two Delaware hospital patients who were given the blood thinner heparin. Officials at Beebe Medical Center in Lewes reported last week that three patients suffered adverse reactions after being given the drug last week. Two of the patients, a 71-year-old man who was transferred to Christiana Hospital in Newark, Del., and a 64-year-old woman taken to the University of Maryland medical center, died over the weekend. The third patient, a 68-year-old man, remained hospitalized Monday at Christiana. All three suffered cerebral hemorrhages. "The FDA has been here and they've taken over complete control of the investigation," said Wallace Hudson, vice president of corporate affairs for Beebe. "The whole point of this investigation is to find out if there's some unusual occurrence that would result in this outcome. We don't know," added Hudson, who was notified of the deaths Monday morning. FDA spokeswoman Karen Riley said an agency representative traveled to Beebe on Friday night to collect intravenous bags, then drove them early Saturday to an FDA regional lab in Queens, N.Y. Initial testing did not reveal any problems, but samples have been shipped to another FDA lab in Cincinnati for further testing, Riley said. "So far we've found nothing," she said. "We're moving very expeditiously," added Riley, who said in a prepared statement that, at this point, "this appears to be an isolated incident." The heparin was provided by Baxter Healthcare Corp., a unit of Deerfield, Ill.-based Baxter International Inc., which was involved in a heparin recall last year following several reports of adverse reactions. Hudson said Beebe has switched to another supplier pending the outcome of the investigation. Baxter spokeswoman Erin Gardiner said the company has not received reports from any other institutions regarding heparin but is working with Beebe and the FDA. "We are thoroughly investigating," Gardiner said. "At this point, its premature to speculate on the relationship, if any, between the reactions and our product." Gardiner said last week that premix bags such as those used at Beebe were not involved in last year's recall, which involved contaminated product from China and resulted in stepped-up oversight of suppliers by Baxter. Gardiner said Pfizer supplied the active ingredient used in the premix bags, and that the finished product was made by Baxter at a facility in Puerto Rico. "We're looking at everything on our end," she said. Rick Chambers, a spokesman for New York-based Pfizer, said the heparin provided to Baxter was manufactured at a Pfizer plant outside Dayton, Ohio, and that the company has provided samples from the same lot to the FDA for testing. "We are cooperating fully with Baxter and the FDA on their investigation," he said.
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