FDA investigating Del. heparin deaths

Associated Press / May 12, 2009
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DOVER, Del. - The Food and Drug Administration said yesterday 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. 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 yesterday 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.

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 testing, Riley said, adding that, "So far we've found nothing."

Riley said in a prepared statement that, at this point, "this appears to be an isolated incident."

The heparin was provided by Baxter Healthcare Corp., which was involved in a heparin recall last year following several reports of adverse reactions.

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.