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Tag Archives: FDA warning
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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Eba Multivitamin Supplement Saratoga Therapeutics LLC Recall
TranslationEba Multivitamin Supplement By Saratoga Therapeutics LLC: Recall – Allergy Alert On Undeclared Milk Components AUDIENCE: Consumer, Patient, Health Professional ISSUE: Saratoga Therapeutics, LLC of North Wales, PA recalled 900 bottles of ebA Multivitamin Supplement because they may contain undeclared … Continue reading
Posted in Consumer Products, FDA 2013, FDA Recall, Healthcare Professionals, Patients
Tagged Consumer, Consumer Products, drug risks, Eba Multivitamin Supplement, Eba Multivitamin Supplement Saratoga Therapeutics LLC Recall, FDA recall, FDA warning, Health Professional, Patient, Recall, Saratoga Therapeutics LLC
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Neptune 1 Silver and Neptune 2 Ultra Safety Communication
TranslationStryker 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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Incretin Mimetic Drugs for Type 2 Diabetes
TranslationIncretin Mimetic Drugs for Type 2 Diabetes: Early Communication – Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas AUDIENCE: Gastroenterology, Endocrinology, Oncology, Patient ISSUE: FDA is evaluating unpublished new findings by a group of … Continue reading
Posted in Endocrinology, FDA 2013, FDA Warning, Gastroenterology, Oncology, Patients
Tagged drug risks, Endocrinology, FDA warning, Gastroenterology, Incretin Mimetic Drugs, Incretin Mimetic Drugs for Type 2 Diabetes, Oncology, Patient, Type 2 Diabetes
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Hamilton Medical Inc HAMILTON T1 Ventilators
TranslationHamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower AUDIENCE: Anesthesiology, Risk Managers ISSUE: During ventilation of small pediatric patients with high airway resistance and low lung function, there may be unexpected high internal oxygen consumption by HAMILTON-T1 … Continue reading
Posted in Anesthesiology, FDA 2013, FDA Safety Communication, FDA Warning, Risk Manager
Tagged Anesthesiology, Drug Safety Communication, FDA notice, FDA warning, Hamilton Medical Inc, Hamilton Medical Inc HAMILTON T1 Ventilators, HAMILTON T1, Risk Managers, Safety Communication, Ventilators
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Samsca tolvaptan Drug Warning
TranslationSamsca (tolvaptan): Drug Warning – Potential Risk of Liver Injury AUDIENCE: Gastroenterology, Nephrology, Pharmacy ISSUE: Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebo-controlled trial in about 1400 … Continue reading
Posted in FDA 2013, FDA Warning, Gastroenterology, Nephrology, Pharmacy
Tagged drug risks, Drug Warning, FDA notice, FDA warning, Gastroenterology, Nephrology, Pharmacy, Risk of Liver Injury, Samsca, Samsca tolvaptan Drug Warning, tolvaptan
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New England Compounding Center Fungal Meningitis Outbreak
TranslationNew England Compounding Center (NECC) Potentially Contaminated Medication: Fungal Meningitis Outbreak Latest Update from The FDA AUDIENCE: Surgery, Anesthesia, Neurology, Healthcare Professionals ISSUE: FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial … Continue reading
Posted in Anesthesiology, FDA 2012, FDA Warning, Healthcare Professionals, Neurology, Surgery
Tagged Anesthesia, CDC, drug risks, FDA news, FDA warning, Fungal Meningitis Outbreak, Healthcare Professionals, injectable steroid, methylprednisolone acetate, Neurology, New England Compounding Center, New England Compounding Center Fungal Meningitis Outbreak, Surgery
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Intestinomicina by Laboratorios Lopez Safety Alert
TranslationIntestinomicina (contains chloramphenicol) by Laboratorios Lopez: Safety Alert – Contains Drug Ingredient Withdrawn from US AUDIENCE: Consumer, Health Professional ISSUE: FDA is warning consumers not to use Intestinomicina, a drug product manufactured in El Salvador and marketed as a … Continue reading
Revatio sildenafil Drug Safety Communication
TranslationRevatio (sildenafil): Drug Safety Communication – Recommendation Against Use in Children AUDIENCE: Pediatrics, Cardiology, Pulmonology ISSUE: FDA notified healthcare professionals and their medical care organizations that Revatio (sildenafil) should not be prescribed to children (ages 1 through 17) for pulmonary … Continue reading
Posted in Cardiology, FDA 2012, FDA Safety Communication, FDA Warning, Pediatrics, Pulmonology
Tagged Cardiology, drug risks, Drug Safety Communication, FDA warning, PAH, Pediatrics, pulmonary arterial hypertension, Pulmonology, Revatio, Revatio sildenafil Drug Safety Communication, safety label changes, Safety Labeling Changes, sildenafil
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Codeine Use in Certain Children Drug Risks
TranslationCodeine Use in Certain Children After Tonsillectomy and/or Adenoidectomy: Drug Safety Communication – Risk of Rare, But Life-Threatening Adverse Events or Death AUDIENCE: Pediatricians, Surgery, Consumer ISSUE: The FDA is reviewing reports of children who developed serious adverse effects or … Continue reading