-
Recent Posts
Categories
- Anesthesiology
- Avandia
- Biomedical Engineering
- Cardiology
- Clinical Trials
- Clinics
- Consumer Products
- Counterfeit Products
- Critical Care Medicine
- Dentistry
- Dermatology
- Emergency Rooms
- Endocrinology
- Eye Care
- Family Practice
- FDA 2011
- FDA 2012
- FDA 2013
- FDA Label Change
- FDA Notice
- FDA Recall
- FDA Safety Communication
- FDA Warning
- Gastroenterology
- Healthcare Professionals
- Hematology
- Home Care
- Hospitals
- Infectious Disease
- Internal Medicine
- Laboratory
- multiple sclerosis (MS)
- Nephrology
- Neurology
- Nursing
- OBGYN
- Oncology
- Ophthalmology
- Orthopaedic Surgery
- Pain Management
- Patients
- Pediatrics
- Pharmacy
- Physical Medicine
- Psychiatry
- Pulmonology
- Radiology
- Rheumatology
- Risk Manager
- Surgery
- Uncategorized
Archives
- May 2013
- April 2013
- March 2013
- February 2013
- January 2013
- December 2012
- November 2012
- October 2012
- September 2012
- August 2012
- July 2012
- June 2012
- May 2012
- April 2012
- March 2012
- February 2012
- January 2012
- December 2011
- November 2011
- October 2011
- September 2011
- August 2011
- July 2011
- June 2011
- May 2011
Monthly Archives: June 2011
Erythropoiesis Modified Dosing Recommendations
Translation Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication – Modified Dosing Recommendations Epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp) AUDIENCE: Nephrology, Oncology ISSUE: FDA notified healthcare professionals that new, modified … Continue reading
Posted in FDA 2011, FDA Notice
Tagged Erythropoiesis Modified Dosing Recommendations, FDA notice
Comments Off
Risperdal (risperidone) and Risperidone Recall
TranslationRisperdal (risperidone) and Risperidone: Recall – Uncharacteristic Odor AUDIENCE: Pharmacy, Psychiatry, Neurology, Internal Medicine ISSUE: Ortho-McNeil-Janssen Pharmaceuticals notified healthcare professionals and the public of a recall of specific lots of Risperdal (risperidone) 3mg tablets and risperidone 2mg tablets. The recall … Continue reading
Posted in FDA 2011, FDA Recall
Tagged FDA notice, FDA recall, Risperdal (risperidone) and Risperidone Recall
Comments Off
Boston Scientific Innova Self-Expanding Stent System Recall
TranslationBoston Scientific Innova Self-Expanding Stent System: Recall – Failure to Deploy AUDIENCE: Interventional Radiology, Risk Manager ISSUE: Complaints of no deployment and partial deployment have been received. This type of failure may result in vessel wall injury, increased procedure time … Continue reading
Posted in FDA 2011, FDA Notice, FDA Recall
Tagged Boston Scientific, Class 1 Recall, FDA recall, Innova Self-Expanding Stent System, Recall
Comments Off
Chantix (varenicline) Label Change
TranslationChantix (varenicline): Label Change – Risk of Certain Cardiovascular Adverse Events AUDIENCE: Family Medicine, Cardiology ISSUE: FDA notified healthcare professionals and patients that the Prescribing Information for this drug product will be strengthened to inform the public that use … Continue reading
Posted in FDA 2011, FDA Label Change
Tagged Chantix, Chantix (varenicline) Label Change, FDA notice, safety label changes
Comments Off
Indomethacin for Injection: Recall
TranslationIndomethacin for Injection: Recall of One Lot – Particulate Matter AUDIENCE: Risk Manager, Pharmacy ISSUE: Bedford Laboratories, a division of Ben Venue Laboratories, Inc., initiated a nationwide voluntary recall of Indomethacin for Injection, USP, 1mg Single Dose Vial (NDC #55390-299-01, Lot … Continue reading
Posted in FDA 2011, FDA Recall, FDA Warning
Tagged Bedford Laboratories, FDA recall, Indomethacin for Injection, Recall
Comments Off
MedWatch May 2011 Safety Labeling Changes
TranslationThe MedWatch May 2011 Safety Labeling Changes posting includes 47 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE. The “Summary Page” provides a listing of drug … Continue reading
Posted in FDA 2011, FDA Label Change
Tagged Aciphex, Afinitor, Aldactazide, Avandamet, Avandaryl, Avandia, Benicar HCT, Biaxin Filmtab, Changes, Dexilant, FDA notice, FDA warning, Genotropin, Humalog, Imuran, Labeling, Levatol, MedWatch May 2011, Micardis HCT, Norditropin Cartridges, Omeprazole / Sodium Bicarbonate / Magnesium Hydroxide Tablets, Prevacid, Prevacid SoluTab, Prilosec, PRotonix, Purinethol, safety, safety label changes, Seroquel, Sutent, Teveten HCT, Uniretic, Vimovo, Zegerid, Ziac
Comments Off
Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters Recall
TranslationBoston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters: Recall – Catheter Tip Can Break Inside of the Patient AUDIENCE: Cardiology, Surgery ISSUE: The catheter tip can break inside of the patient and embolize causing tissue and blood … Continue reading
Posted in FDA 2011, FDA Recall
Tagged Boston Scientific iCross and Atlantis SR Pro 2, Catheters, Class 1 Recall, Coronary Imaging, FDA recall, Recall
Comments Off
Terumo Coronary Ostia Cannula 10, 12, 14 Fr: Recall
Translation Terumo Coronary Ostia Cannula 10, 12, 14 Fr: Recall – Fragments of Adhesive and Plastic in the Cannula Tip May Embolize AUDIENCE: Cardiology, Surgery ISSUE: Foreign fragments of adhesive and plastic in the cannula tip may embolize causing arterial … Continue reading
Posted in FDA 2011, FDA Notice, FDA Recall
Tagged Class 1 Recall, FDA notice, FDA recall, Terumo Coronary Ostia Cannula
Comments Off
Maquet Datascope Corp. Intra-Aortic Balloon Pumps: Recall
TranslationMaquet Datascope Corp. Intra-Aortic Balloon Pumps: Recall – Shuts Off Without Warning AUDIENCE: Cardiology, Surgery ISSUE: A defective fan in the power supply may cause overheating and shut down the device without visible or audible alarms. Consequences of … Continue reading
Posted in FDA 2011, FDA Notice, FDA Recall
Tagged Class 1 Recall, FDA notice, FDA recall, Intra-Aortic Balloon Pumps, Maquet Datascope Corp
Comments Off
Risperidone (Risperdal) and Ropinirole (Requip)
TranslationRisperidone (Risperdal) and Ropinirole (Requip): Medication Errors – Name Confusion AUDIENCE: Pharmacy, Psychiatry, Neurology, Internal Medicine ISSUE: FDA notified healthcare professionals and the public of medication error reports in which patients were given risperidone (Risperdal) instead of ropinirole (Requip) … Continue reading
Posted in FDA 2011, FDA Notice, FDA Warning
Tagged FDA notice, FDA warning, Medication Errors, Name Confusion, Risperidone (Risperdal), Ropinirole (Requip)
Comments Off