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[Posted 10/22/2015] AUDIENCE: Patient, Infectious Disease, Pharmacy ISSUE: FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, FDA is requiring the manufacturer to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions,…

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Including all heater-cooler devices providing heated and/or cooled water to: oxygenator heat exchangers, cardioplegia (paralysis of the heart) heat exchangers, and/or warming/cooling blankets.   [Posted 10/15/2015] AUDIENCE: Surgery, Infectious Disease, Risk Manager ISSUE: Through analysis of adverse event reports, the medical literature, and information from national and international public health agencies, FDA is aware that…

[Posted 10/14/2015] AUDIENCE: Pharmacy, Consumer ISSUE: On October 9, 2015, Medline Industries, Inc. announced that it will initiate a voluntary nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg, uncoated compressed tablets to the consumer level. The Acetaminophen 500mg, Tab 100/BT (OTC20101) has been found to be mislabeled displaying “Acetaminophen 325mg” (OTC10101) instead of…

[Posted 10/05/2015] AUDIENCE: Cardiology, Surgery, Risk Manager ISSUE: The FDA is aware of recent reports regarding reduced leaflet motion in some bioprosthetic aortic valves, including both SAVR and TAVR devices. Importantly, most cases of reduced leaflet motion were discovered by advanced imaging studies in patients without symptoms of abnormal bioprosthetic valve function. Further, these studies…

[Posted 10/03/2015] AUDIENCE: Pharmacy, Compounding, Nursing, Risk Manager ISSUE: During FDA’s recent inspection of Park Compounding Pharmacy’s facility, FDA investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about the company’s ability to assure the sterility of drug products that it produced. The FDA is alerting health care professionals and patients not…

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