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Category Archives: FDA Warning
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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Incretin Mimetic Drugs for Type 2 Diabetes
Incretin 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Findings of the Pancreas AUDIENCE: Gastroenterology, Endocrinology, Oncology, Patient ISSUE: FDA is evaluating unpublished new findings by a group of … Continue reading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
Hamilton 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
Samsca (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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Pradaxa dabigatran etexilate mesylate Drug Safety Communication
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication – Should Not Be Used in Patients with Mechanical Prosthetic Heart Valves AUDIENCE: Cardiology, Patient ISSUE: The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the … Continue reading
Posted in Cardiology, FDA 2012, FDA Notice, FDA Warning, Patients
Tagged dabigatran etexilate mesylate, Drug Safety Communication, Pradaxa, Pradaxa (dabigatran etexilate mesylate) Drug Safety Communication
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FDA Statement on Fungal Meningitis Outbreak
Fungal Meningitis Outbreak [UPDATE 11-01-2012] Laboratory results from samples of two additional recalled NECC products – preservative free betamethasone and cardioplegia solution – have tested positive for bacterial contamination. FDA and CDC laboratories have identified bacteria present in three separate … Continue reading
Posted in FDA 2012, FDA Warning, Pain Management, Pharmacy, Risk Manager
Tagged drug risks, FDA Statement, FDA Statement on Fungal Meningitis Outbreak, Fungal Meningitis Outbreak, NECC, New England Compounding Center, Pain Medicine, Pharmacists, Risk Managers, updated
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New England Compounding Center Fungal Meningitis Outbreak
New 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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Revatio sildenafil Drug Safety Communication
Revatio (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
Codeine 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
Ampyra dalfampridine drug risks
Drug Safety Communication – Seizure Risk for Multiple Sclerosis Patients AUDIENCE: Neurology, Internal Medicine ISSUE: FDA is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine). … Continue reading
Posted in FDA 2012, FDA Safety Communication, FDA Warning, Internal Medicine, Neurology
Tagged Ampyra, Ampyra dalfampridine Drug Risks, dalfampridine, drug risks, Drug Safety Communication, FDA warning, Internal Medicine, MS, multiple sclerosis, Neurology, seizures
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