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HSAG ESRD Alerts, Recalls, and Notices

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  • Ocaliva (obeticholic acid): Drug Safety Communication - Increased Risk of Serious Liver Injury

    Friday, September 22, 2017
    FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. These patients are receiving excessive dosing, particularly a...

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  • Guidance to All Providers Regarding Provision of Services During Hurricane Irma

    Monday, September 18, 2017
    Guidance to All Providers Regarding Provision of Services During Hurricane Irma. This Guidance Applies for Both Fee-For-Service and Managed Care Providers.

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  • Rifampin/Penicillin-Resistant Strain of RB51 Brucella Contracted from Consumption of Raw Milk

    Wednesday, September 13, 2017
    The Texas Department of State Health Services, with assistance from CDC, is investigating Brucella RB51 exposures and illnesses that may be connected to the purchase and consumption of raw (unpasteurized) milk from K-Bar Dairy in Paradise, Texas. Symptoms of brucellosis can include: fever, sweats,...

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  • Medtronic Announces Voluntary Recall of Diabetes Infusion Sets

    Tuesday, September 12, 2017
    Medtronic plc (NYSE:MDT) announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include...

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  • Activase (alteplase) 100mg by Genentech: Recall - Lack of Sterility Assurance

    Thursday, September 7, 2017
    Genentech is voluntarily recalling three lots of Activase (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be...

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  • Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing

    Wednesday, September 6, 2017
    FDA is recommending that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) at the same time as other medicines taken by mouth. A study found that sodium polystyrene sulfonate binds to many commonly prescribed oral medicines, decreasing the absorption and...

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  • Hurricane Harvey—Clinical Guidance for Carbon Monoxide (CO) Poisoning

    Tuesday, September 5, 2017
    Hurricane Harvey made landfall between Port Aransas and Port O’Connor, Texas on August 25, 2017, causing 300,000 persons to lose power. When power outages occur during emergencies such as hurricanes or winter storms, the use of alternative sources of fuel or electricity for heating, cooling, or...

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  • Hospira Issues Voluntary Worldwide Recall For Lots of Hydromorphone HCl Injection

    Friday, September 1, 2017
    Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a...

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  • Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products

    Friday, September 1, 2017
    The U.S. Food and Drug Administration is alerting health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues.

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  • Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold

    Thursday, August 31, 2017
    Based on data from two recently halted clinical trials, the U.S. Food and Drug Administration today is issuing this statement to inform the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with...

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