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Thread: U.S. FDA warns on company's injectable drugs

  1. #1

    U.S. FDA warns on company's injectable drugs

    16テつ*Novテつ*2002テつ*01:55
    U.S. FDA warns on company's injectable drugs
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    WASHINGTON, Nov 15 (Reuters) - Injectable drugs made by Urgent Care Pharmacy of Spartanburg, South Carolina may not be sterile and should not be used, the U.S. Food and Drug Administration said on Friday.

    One person has died because of contaminated drugs made by the company, the FDA said; it is looking for anyone else who may have been given products made by Urgent Care.

    The firm manufactures drugs ranging from painkillers to hormone treatments.

    "Urgent Care has refused to voluntarily recall any other injectable products they prepared and refused to provide FDA with a complete list of products they distributed," the agency said in a statement.

    "FDA is working to identify the recipients of these products so that the agency can directly alert them to the serious risks involved. FDA is continuing to work with the Centers for Disease Control (and Prevention), along with officials from both North Carolina and South Carolina, and will take whatever additional action is needed."

    It said the South Carolina Board of Pharmacy had issued an order to halt further sale of products from Urgent Care.

    It said doctors, hospitals and clinics in Connecticut, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Mississippi, New Hampshire, North Carolina, South Carolina and Virginia had bought drugs made by Urgent Care.
    http://www.alertnet.org/thenews/newsdesk/N15193500

    16テつ*Novテつ*2002テつ*01:55

    "On September 16, 2002, Urgent Care recalled all lots of its injectable methylprednisolone acetate based on reports of four patients who developed a rare fungal (wangiella) meningitis (a life threatening infection of the lining of the brain and spinal cord) after use of their product," the FDA said.

    "These patients were treated at three different North Carolina hospitals/clinics." It said one of the patients died.

    Drugs distributed by the company include betamethasone, Bimix, clonidine, estradiol, hydromorphone HCl, fentanyl, methylprednisole acetate, morphine, papaverine HCl, Super Trimix (Papaverine HCl/phentolamine mesylate/prostaglandin), and two testosterone formulations.

  2. #2
    http://www.fda.gov/bbs/topics/ANSWER.../ANS01171.html

    FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
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    T02-44 Media Inquiries: 301-827-6242
    November 15, 2002 Consumer Inquiries: 888-INFO-FDA
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    NATIONWIDE ALERT ON INJECTABLE DRUGS PREPARED BY URGENT CARE PHARMACY

    The Food and Drug Administration (FDA) is announcing a nationwide alert concerning all injectable drugs prepared by Urgent Care Pharmacy of Spartanburg, South Carolina, based on the lack of assurance that their products are sterile. Non-sterility of injectable products can represent a serious hazard to health that could lead to life-threatening injuries and death. FDA inspection of Urgent Care's facility revealed the firm failed to have adequate controls to ensure necessary sterility, including the absence of appropriate testing for potency and sterility prior to distribution.

    On September 16, 2002, Urgent Care recalled all lots of its injectable methylprednisolone acetate based on reports of four patients who developed a rare fungal (wangiella) meningitis (a life threatening infection of the lining of the brain and spinal cord) after use of their product. These patients were treated at three different North Carolina hospitals/clinics. Spinal fluid from all of these patients tested positive for a fungus consistent with that found in the Urgent Care product analyzed by both the FDA and Centers for Disease Control and Prevention (CDC). One patient later died despite antifungal therapy.

    Urgent Care has refused to voluntarily recall any other injectable products they prepared and refused to provide FDA with a complete list of products they distributed. FDA is working to identify the recipients of these products so that the agency can directly alert them to the serious risks involved. FDA is continuing to work with the Centers for Disease Control, along with officials from both North Carolina and South Carolina, and will take whatever additional action is needed.

    In the meantime, the South Carolina Board of Pharmacy has issued a Cease and Desist order to halt further sale of products from Urgent Care.

    At the present time, based on limited information, FDA is aware that Urgent Care has distributed the following injectable drugs to physicians, hospitals, clinics and consumers in Connecticut, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Mississippi, New Hampshire, North Carolina, South Carolina and Virginia:

    Baclofen
    Betamethasone
    Bimix 30:1 (Phentolamine mesylate/papaverine)
    Clonidine
    Estradiol
    Hydromorphone HCl
    Fentanyl
    Methylprednisole acetate
    Morphine Sulfate/Bupivacaine
    Papaverine HCl
    Super Trimix (Papaverine HCl/phentolamine mesylate/prostaglandin)
    Testosterone cypionate
    Testosterone/Estradiol

    Urgent Care injectables are labeled as URGENT CARE PHARMACY 2500 WINCHESTER PLACE , STE. 106, SPARTANBURG, SC 29301, 800-692-8982.

    Consumers, physicians, and health care workers are urged to examine their drug supplies for any Urgent Care injectable products and immediately discontinue their use. Users should also notify FDA of any complaints or problems associated with these products.

    These reports may be made to MedWatch, the FDA's voluntary reporting program, by phone at 1-800-FDA-1088 or on line at http://www.fda.gov/medwatch/how.htm

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