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FDA Safety Alerts
  • ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - UPDATE - Follow Pentax Validated Reprocessing Instructions

    Tuesday, January 17, 2017 9:00:00 AM CST
    Updated recommendations to help prevent the spread of infection associated with the use of these devices. [...] Read More..
  • Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery

    Friday, January 13, 2017 11:00:00 PM CST
    Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017 [...] Read More..
  • Duodenoscopes by Fujifilm Medical Systems: Safety Communication - Certain Older Models Removed From Clinical Use

    Friday, January 13, 2017 10:00:00 AM CST
    Fuji removing legacy 250/450 duodenoscope models from clinical use, replacing with with the ED-530XT model. [...] Read More..
  • PNC-27 Products: FDA Warning – Do Not Use For Treatment or Cure for Cancer

    Thursday, January 12, 2017 8:00:00 AM CST
    Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections. [...] Read More..
  • Medrad Intego PET Infusion System Source Administration Sets by Bayer: Recall - Particulates Generated in Vial

    Wednesday, January 11, 2017 4:30:00 PM CST
    The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death. [...] Read More..
  • Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication - Important Safety Precautions

    Wednesday, January 11, 2017 9:50:00 AM CST
    Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam. [...] Read More..
  • Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication - Cybersecurity Vulnerabilities Identified

    Sunday, January 08, 2017 11:00:00 PM CST
    These vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient's RF-enabled implanted cardiac device by altering the Merlin@home Transmitter. [...] Read More..
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  • ZIKV Detect IgM Capture ELISA by InBios International, Inc: FDA Safety Communication - Wait for Confirmatory Test Results Before Making Patient Management Decisions

    Friday, December 23, 2016 8:35:00 AM CST
    IgM tests remain useful in ruling out Zika exposure, but require confirmatory testing. Do not rely on presumptive positive Zika virus IgM test results as the sole basis of significant patient management decisions. [...] Read More..
  • Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall - Inadequate Sterilization

    Tuesday, December 20, 2016 9:00:00 AM CST
    Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death. [...] Read More..
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  • Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - Mental Health Side Effects Revised

    Friday, December 16, 2016 11:01:00 AM CST
    FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected. [...] Read More..
  • General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women

    Wednesday, December 14, 2016 11:01:00 AM CST
    Published studies in pregnant animals and young animals have shown the use of general anesthetic and sedation drugs for more than 3 hours caused widespread loss of nerve cells in the brain. [...] Read More..
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  • Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer

    Monday, December 12, 2016 2:05:00 PM CST
    FDA approved label updates to describe additional studies reviewed. [...] Read More..
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Avoiding Drug Interactions

Avoiding Drug Interactions
People often combine foods. For example, chocolate and peanut butter might be considered a tasty combination. But eating chocolate and taking certain drugs might carry risks. In fact, eating chocolate and taking monoamine oxidase...
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