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    Sunday, June 21, 2009


    Two Delaware patients died after taking heparin, a widely used blood thinner made by Baxter International Inc. In addition, a third patient suffered medical problems. Indeed "all three were using heparin," however, "there was no specific evidence tying heparin to the illness.

    At Beebe Medical Center in Lewes, DE, where the deaths occurred, heparin use was suspended. The new complications involve premixed intravenous bags of heparin. Because of its ability to repress clotting and coagulation, the drug can cause serious side effects if administered in too high a dose. The company, however, said on 5/15 after testing that results of forensic and analytical tests verified that the heparin used at Beebe was of the proper purity and potency, "All tests on samples obtained from the hospital, retained samples from the same lot, and samples produced before and after the lot in question confirmed that the product's formulation was within specifications and met all requirements."

    Medical evaluations of the patients indicated that "the intracranial bleeding was related to underlying medical conditions and risk factors that increase the relative risks involved in using a particular drug," the statement said. "The unfortunate patient events that occurred at Beebe Medical Center were isolated, institution-specific issues. The FDA spokeswoman said agency investigators inspected Baxter's facilities and tested heparin products there as well as samples collected at Beebe and said the findings thus far confirmed Baxter's account.

    This incident sparked concerns about a repeat of fatal heparin contamination in 2008.

    The manufacturer of the heparin involved in the Beebe cases, Baxter Healthcare Corp., recalled batches of the drug in 2008 after the Food and Drug Administration found it was contaminated with a chemical that caused serious allergic reactions and low blood pressure in patients who received high doses. Imports from a Chinese manufacturer of an ingredient in heparin have been banned in connection with that contamination.

    In the 2008 heparin deaths, however, the bulk material came from China.

    In those incidents, FDA officials and Baxter believed a substance known as oversulfated chondroitin sulfate was intentionally put into the product from suppliers in China.
    No Chinese suppliers are involved in the latest incidents.

    What to do to help curtail Heparin problems: Multiple Dose Heparin Vials Risky for Patients
    According to The Institute for Safe Medication Practices (ISMP), a non-profit organization devoted to medication error prevention and safe medication,, multiple dose Heparin vials have potentially confusing labels that can lead to dangerous overdoses.
    The overdoses may cause serious injury to patients and even death. (Heparin is used to prevent blood clots.)
    The problem with the vials is that although they contain 4 mL of Heparin solution, they are labeled “10,000 USP units/1 mL,” with the “10,000″ in extra large print. This labeling may cause a healthcare professional to assume that the entire vial contains 10,000 units and as a result, the professional may administer a dose of Heparin that is four times more than a patient should receive. This problem may not have been the case @ Beebe Hospital since it appears that the heparin came from premixed bags.
    But, in light of this danger, the ISMP is urging hospitals, doctors, nurses, and all other healthcare professionals to carefully read the label on vials of Heparin before administering the drug to patients and is advising hospitals to consider whether they should stock any Heparin vials that contain more than 10,000 units per vial.

    If you are hospitalized and Heparin has been prescribed for you, keep yourself safer by requesting that the drug be administered from a single dose, not a double dose, vial.

    Please remember, as with all our articles we provide information, not medical advice.

    For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

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