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2016

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  • FDA MedWatch: Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer

    Monday, December 19, 2016

    As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. The labels of pioglitazone-containing medicines already contain warnings about this risk, and FDA has approved label updates to describe the additional studies reviewed.

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  • ZIKA UPDATE: CDC Guidance for Travel and Testing of Pregnant Women and Women of Reproductive Age

    Wednesday, December 14, 2016

    On November 28, 2016, the Texas Department of State Health Services (TDSHS) reported the first case of locally acquired mosquito-borne Zika virus infection in the city of Brownsville, Cameron County, Texas. On December 9, 2016, four additional cases in people living in proximity to the first case were reported. TDSHS continues to investigate Zika virus transmission in Brownsville.

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  • CMS publishes proposed rule on Fire Safety Requirement for Applicable Dialysis Facilities

    Thursday, November 3, 2016

    Today, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule to update Medicare fire protection guidelines for certain dialysis facilities to ensure that patients are protected from fire while receiving treatment in those facilities. CMS strives to promote health and safety for all patients, family, and staff in every provider and supplier setting, and fire safety requirements are an important part of this effort.

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  • Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall - Connector Compatibility Issue

    Tuesday, October 18, 2016

    The Leonhard Lang defibrillation electrode is being recalled due to a connector compatibility issue with the Welch Allyn AED model 10. The user may not be able to connect the electrodes to the defibrillator when a shock is needed. This may result in a delay in delivering the electrical therapy needed to revive a patient in cardiac arrest.

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  • FDA MedWatch: Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected

    Tuesday, October 11, 2016

    FDA and St. Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert. St. Jude Medical has initiated a recall and correction of the affected devices. See the FDA Safety Communication for a listing of affected devices and data summary.

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  • Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating

    Tuesday, October 4, 2016

    The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active
    infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4–8 weeks.

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  • First Human Case of West Nile Viral Disease in NYC in 2016

    Monday, September 12, 2016

    West Nile viral activity continues to increase in New York City in mosquitoes. The first human case of West Nile viral disease was identified in a Brooklyn man. West Nile virus positive mosquito pools have been identified in all five boroughs.

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  • FDA MedWatch: Recall of six batches of GlucaGen® HypoKit®

    Friday, September 9, 2016

    Novo Nordisk Inc. is recalling six batches of the GlucaGen® HypoKit® in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI).

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  • New CMS Emergency Preparedness Rules

    Thursday, September 8, 2016

    The Centers for Medicare & Medicaid Services (CMS) finalized rules to establish consistent emergency preparedness requirements for healthcare providers participating in Medicare and Medicaid, increase patient safety during emergencies, and establish a more coordinated response to natural and man-made disasters. These new rules will require certain participating providers and suppliers to plan for disasters and coordinate with federal, state, tribal, regional, and local emergency preparedness systems to ensure that facilities are adequately prepared to meet the needs of their patients during disasters and emergency situations. The effective date will be November 16, 2016 and the implementation date will be November 16, 2017.

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  • FDA MedWatch: VASCU-GUARD Peripheral Vascular Patch by Baxter

    Thursday, September 1, 2016

    The FDA has recently received multiple adverse event reports associated with Baxter International Inc.’s Vascu-Guard Peripheral Vascular Patch (also referred to as the Vascu- Guard patch) during carotid endarterectomy (CEA). These reports from 2016 include intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention, and three patient deaths potentially related to this issue that occurred shortly after CEA surgery. The device manufacturer, Baxter International, Inc., alerted the FDA to these adverse events.

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