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FDA Investigation Reveals Heparin Cases Were Isolated

A team of company investigators from Baxter International has found that three incidents of intracranial hemorrhage (bleeding in the brain) in patients at a Delaware hospital were not caused by heparin products it manufactured using active ingredients supplied by Pfizer. The company issued a statement on May 15, 2009, after a thorough investigation of heparin, a blood thinner. The drug was administered at Beebe Medical Center in Lewis, Delaware, to three older patients, two of whom died.

Baxter, the largest U.S. supplier of heparin, is cooperating closely with the U.S. Food and Drug Administration (FDA), which has been conducting its own investigation. The FDA has inspected Baxter’s facilities, and its products there and at the hospital. “Results of product testing to date by FDA and Baxter have not revealed any problems,” said Karen Riley, FDA spokesperson. “As far as we can determine at this point, this appears to be an isolated incident.”

Baxter also released a statement regarding the patients’ health conditions at the time. “The intracranial bleeding was related to underlying medical conditions and risk factors that increase the relative risks involved in using a particular drug,” stated the pharmaceutical company.

The cases in Delaware have no connection to patients with bleeding disorders.  In this community, heparin is used to flush ports and catheters to prevent clot formation. It differs from the type used in the affected patients, a diluted form sold in premixed intravenous bags.  It also differs from the heparin sold in vials that Baxter recalled voluntarily in 2008 after reports of adverse reactions in hundreds of patients worldwide. The vials were contaminated with oversulfated chondroitin sulfate found in raw materials in China. Pfizer obtains its active ingredients from a supplier in Ohio.

Baxter International in based in Deerfield, IL.



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