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Tag Archives: Infectious Disease
Medical Bed Mattresses FDA Safety Communication
Translation Medical Bed Mattresses: FDA Safety Communication – Damaged or Worn Covers Pose Risk of Contamination and Infection AUDIENCE: Biomedical Engineering, Infectious Disease, Nursing, Risk Managers ISSUE: From January 2011 to January 2013, the FDA received 458 reports associated with … Continue reading
Posted in Biomedical Engineering, FDA 2013, FDA Label Change, FDA Safety Communication, Infectious Disease, Nursing, Risk Manager
Tagged Biomedical Engineering, Drug Safety Communication, FDA notice, FDA Safety Communication, Infectious Disease, Medical Bed Mattresses, Medical Bed Mattresses FDA Safety Communication, Nursing, Risk Manager, Risk Managers, Safety Communication
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BIVIGAM Immune Globulin Intravenous Recall
TranslationBIVIGAM Immune Globulin Intravenous (Human), 10 Percent Liquid, 100 mL Sterile Vial: Recall – Visible Particles Observed AUDIENCE: Risk Manager, Infectious Disease, Health Professional ISSUE: During a routine annual reserve inspection, visible particles were observed in lot number 120016 (Expiration … Continue reading
Posted in FDA 2013, FDA Recall, Healthcare Professionals, Infectious Disease, Risk Manager
Tagged (Human), 10 Percent Liquid, 100 mL, BIVIGAM Immune Globulin Intravenous, BIVIGAM Immune Globulin Intravenous Recall, Dexilant, drug risks, FDA recall, Gastroenterology, Health Professional, Infectious Disease, Recall, Risk Manager, Sterile Vial
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Sterrad Cyclesure 24 Biological Indicator Safety Communication
Translation Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicator: Safety Communication – Potential Risk of Infection AUDIENCE: Risk Manager, Surgery, Infectious Disease ISSUE: An FDA review of ASP data showed that the Sterrad Cyclesure 24 Biological Indicators cannot effectively … Continue reading
Cefepime Label Change drug risks
TranslationCefepime:Label Change- Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment Audience: Health Professional,Infectious Disease, Nephrology Issue: There have been cases of a specific type of seizure called nonconvulsive status epilepticus associated with the use of … Continue reading
Posted in FDA 2012, FDA Warning, Healthcare Professionals, Infectious Disease, Nephrology
Tagged Adverse Effects, Cefepime, Cefepime Label Change, drug effects, drug reactions, drug risks, FDA warning, Health Professional, Infectious Disease, Nephrology, Risk of Seizure, safety label changes
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Victrelis drug label revised Drug Safety Communication
TranslationVictrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication – Drug Interactions [UPDATED 04/26/2012] FDA notified healthcare professionals that the Victrelis drug label has been revised to state that co-administration of Victrelis (boceprevir), a hepatitis … Continue reading
Posted in FDA 2012, FDA Label Change, FDA Safety Communication, Infectious Disease, Pharmacy
Tagged drug interactions, drug risks, Drug Safety Communication, FDA notice, FDA warning, Infectious Disease, Pharmacy, Ritonavir-Boosted Human Immunodeficiency Virus (HIV), safety label changes, Victrelis (boceprevir)
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Generic Ultrasound Transmission Gel Safety Communication
TranslationOther‐Sonic Generic Ultrasound Transmission Gel: Safety Communication – Risk of Bacterial Contamination AUDIENCE: Risk Manager, OB/GYN, Radiology, Infectious Disease ISSUE: FDA notified health care professionals and facilities to STOP using Other‐Sonic Generic Ultrasound Transmission Gel manufactured June though December 2011, … Continue reading
Posted in FDA 2012, FDA Warning, Infectious Disease, OBGYN, Radiology, Risk Manager
Tagged drug risks, FDA notice, Generic Ultrasound Transmission Gel, Infectious Disease, OBGYN, Other‐Sonic, Radiology, Risk Manager, Safety Communication
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Statins and HIV or Hepatitis C Drugs Drug Safety Communication
TranslationStatins and HIV or Hepatitis C Drugs: Drug Safety Communication – Interaction Increases Risk of Muscle Injury AUDIENCE: Infectious Disease, Family Practice, Patients ISSUE: FDA notified healthcare professionals of updates to the prescribing information concerning interactions between protease inhibitors and certain statin drugs. … Continue reading
Posted in Family Practice, FDA 2012, FDA Safety Communication, Infectious Disease, Patients
Tagged drug interactions, drug risks, Drug Safety Communication, Family Practice, FDA notice, hiv, HIV or Hepatitis C Drugs, Infectious Disease, myopathy, Patients, protease inhibitors, Statins, Statins and HIV or Hepatitis C Drugs Drug Safety Communication
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Diflucan (fluconazole) Birth Defects
TranslationDiflucan (fluconazole): Drug Safety Communication – Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects AUDIENCE: OBGYN, Pharmacy, Infectious Disease ISSUE: FDA is informing the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the … Continue reading
Posted in FDA 2011, FDA Notice, FDA Warning, OBGYN, Pharmacy
Tagged Birth Defects, Diflucan, FDA notice, FDA warning, Fluconazole, Infectious Disease, OBGYN, Pharmacy
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Zyvox (linezolid) Drug Safety Communication
TranslationZyvox (linezolid): Drug Safety Communication – Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications AUDIENCE: Infectious Disease, Psychiatry, Family Practice ISSUE: FDA has received reports of serious central nervous system (CNS) reactions when the antibacterial … Continue reading
Posted in Family Practice, FDA 2011, FDA Notice, Infectious Disease, Psychiatry
Tagged Drug Safety Communication, Family Practice, Infectious Disease, linezolid, Psychiatry, Zyvox
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