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Category Archives: FDA Safety Communication
The Compounding Shop FDA News Release
The Compounding Shop: FDA News Release – Lack of Sterility Assurance of Drug Products AUDIENCE: Pharmacy, Healthcare Professionals, Patients ISSUE: The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary … Continue reading
Posted in FDA 2013, FDA Safety Communication, Healthcare Professionals, Patients, Pharmacy
Tagged drug risks, Drug Safety Communication, FDA News Release, FDA notice, Healthcare Professionals, Patients, Pharmacy, Safety Communication, The Compounding Shop, The Compounding Shop: FDA News Release
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Covidien Surgical Stapler Reloads FDA Safety Communication
Posted in Biomedical Engineering, FDA 2013, FDA Safety Communication, Nursing, Risk Manager, Surgery
Tagged Biomedical Engineering, Covidien, Covidien Surgical Stapler Reloads FDA Safety Communication, FDA Safety Communication, FDA warning, Nursing, Risk Managers, Safety Communication, Surgery, Surgical Stapler Reloads
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Valproate Anti-Seizure Products Drug Safety Communication
Valproate Anti-Seizure Products: Drug Safety Communication – Contraindicated for Pregnant Women for Prevention of Migraine Headaches Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics AUDIENCE: Health Professional, Neurology, … Continue reading
Posted in FDA 2013, FDA Safety Communication, Healthcare Professionals, Neurology, Patients, Pharmacy
Tagged anti-seizure medication, Anti-Seizure Products, divalproex sodium, Drug Safety Communication, Health Professional, Neurology, Patient, Pharmacy, pregnant women, Valproate, Valproate Anti-Seizure Products Drug Safety Communication, valproate sodium, valproic acid
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Samsca Tolvaptan Drug Safety Communication
Samsca (Tolvaptan): Drug Safety Communication – FDA Limits Duration and Usage Due To Possible Liver Injury Leading to Organ Transplant or Death AUDIENCE: Pharmacy, Health Professional, Patient ISSUE: FDA has determined that the drug Samsca (tolvaptan) should not be used … Continue reading
Posted in FDA 2013, FDA Safety Communication, Healthcare Professionals, Patients, Pharmacy
Tagged drug risks, Drug Safety Communication, FDA notice, Health Professional, Patient, Pharmacy, Risk Managers, Safety Communication, Samsca, Samsca Tolvaptan Drug Safety Communication, tolvaptan
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Potiga Ezogabine Drug Safety Communication
Potiga (Ezogabine): Drug Safety Communication – Linked To Retinal Abnormalities And Blue Skin Discoloration AUDIENCE: Health Professional, Neurology, Patient ISSUE: FDA is warning the public that the anti-seizure medication Potiga (Ezogabine) can cause blue skin discoloration and eye abnormalities characterized … Continue reading
Posted in FDA 2013, FDA Safety Communication, Healthcare Professionals, Neurology, Patients
Tagged Blue Skin Discoloration, drug risks, Drug Safety Communication, Ezogabine, FDA notice, Health Professional, Neurology, Patient, Potiga, Potiga Ezogabine Drug Safety Communication, Retinal Abnormalities, Safety Communication
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Medical Bed Mattresses FDA Safety Communication
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 medical … 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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MedWatch March 2013 Safety Labeling Changes
The MedWatch March 2013 Safety Labeling Changes posting includes 53 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of drug names and … Continue reading
Neptune 1 Silver and Neptune 2 Ultra Safety Communication
Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication – Reports of Serious Tissue Damage and Patient Death [UPDATE 03/15/2012] In the past 6 months, the FDA has become … Continue reading
Posted in FDA 2013, FDA Safety Communication, FDA Warning
Tagged drug risks, FDA warning, Neptune 1 Silver, Neptune 1 Silver and Neptune 2 Ultra Safety Communication, Neptune 2 Ultra, Safety Communication
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February 2013 Safety Labeling Changes
The MedWatch February 2013 Safety Labeling Changes posting includes 35 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of drug names and … Continue reading
Posted in FDA 2013, FDA Safety Communication
Tagged drug risks, FDA notice, February 2013, February 2013 Safety Labeling Changes, Safety Communication, safety label changes, Safety Labeling Changes
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Azithromycin Zithromax or Zmax Drug Safety Communication
Azithromycin (Zithromax or Zmax): Drug Safety Communication – Risk of Potentially Fatal Heart Rhythms AUDIENCE: Family Practice, Patient, Pharmacy, Health Professional ISSUE: FDA is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity … Continue reading