Tag Archives: Infectious Disease

Medical Bed Mattresses FDA Safety Communication

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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

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Posted in Biomedical Engineering, FDA 2013, FDA Label Change, FDA Safety Communication, Infectious Disease, Nursing, Risk Manager | Tagged , , , , , , , , , , | Comments Off

BIVIGAM Immune Globulin Intravenous Recall

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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

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Posted in FDA 2013, FDA Recall, Healthcare Professionals, Infectious Disease, Risk Manager | Tagged , , , , , , , , , , , , , | Comments Off

Sterrad Cyclesure 24 Biological Indicator Safety Communication

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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

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Posted in FDA 2012, FDA Safety Communication | Tagged , , , , , | Comments Off

Cefepime Label Change drug risks

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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

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Posted in FDA 2012, FDA Warning, Healthcare Professionals, Infectious Disease, Nephrology | Tagged , , , , , , , , , , , | Comments Off

Victrelis drug label revised Drug Safety Communication

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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

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Posted in FDA 2012, FDA Label Change, FDA Safety Communication, Infectious Disease, Pharmacy | Tagged , , , , , , , , , | Comments Off

Generic Ultrasound Transmission Gel Safety Communication

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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

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Posted in FDA 2012, FDA Warning, Infectious Disease, OBGYN, Radiology, Risk Manager | Tagged , , , , , , , , | Comments Off

Statins and HIV or Hepatitis C Drugs Drug Safety Communication

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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

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Posted in Family Practice, FDA 2012, FDA Safety Communication, Infectious Disease, Patients | Tagged , , , , , , , , , , , , | Comments Off

Diflucan (fluconazole) Birth Defects

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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

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Posted in FDA 2011, FDA Notice, FDA Warning, OBGYN, Pharmacy | Tagged , , , , , , , | Comments Off

Zyvox (linezolid) Drug Safety Communication

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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

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Posted in Family Practice, FDA 2011, FDA Notice, Infectious Disease, Psychiatry | Tagged , , , , , | Comments Off