FDA: Beebe, heparin investigation closed

A Food and Drug Administration investigation has ended after finding no problems with heparin administered to Beebe Medical Center patients in May.

Karen Riley, a Food and Drug Administration spokeswoman, said the agency’s analysis of heparin manufactured by Baxter Healthcare Corp and used at Beebe, and heparin from the same production lot used at the same time by other high-volume medical facilities, found nothing wrong with the drug.

Heparin is a widely used anticoagulant – blood-thinning drug.

Beebe officials in May notified FDA and Baxter officials about concerns after five patients who had received premixed, intravenous doses of the drug suffered suspected adverse reactions.

Two patients who were flown by helicopter from Beebe – one to Christiana Care near Wilmington, the other to the University of Maryland Hospital in Baltimore, died during the ensuing weekend.

Beebe officials said the patients experienced intracranial bleeding after being given the drug.

Baxter investigators, following tests of the drug and reviews of patient medical histories, found no link between the deaths and the company’s heparin.

Erin Gardiner, a Baxter Healthcare spokeswoman, said in May, “this is an institution-specific issue and not a product-quality issue.”

Wally Hudson, Beebe Medical Center vice president of corporate affairs, said Beebe’s medical staff followed proper hospital procedure when the drug was administered. He said the medical center continuously evaluates protocol and procedure and found nothing requiring change.

Hudson said two patients who had continued to receive treatment at Beebe were later discharged. The outcome for the third patient, who was also flown to Christiana, isn’t known.

Heparin, which is derived from the mucosal lining of pig intestines, has been produced and marketed as an anticoagulant for decades.