U.S. Food and Drug Administration News

Information on Nutrition and Medications

>

Preventing Medical Errors: Potentially Fatal Glucose Monitoring Errors with Icodextrin

Published in September 30th, 2008
Posted by Food and Drug Adminstration (FDA): Patient Safety News in Safety Information
Comments Off

The Institute for Safe Medication Practices (ISMP) is warning again about the possibility of potentially fatal glucose monitoring errors in patients receiving products that contain other sugars. These include oral xylose, parenterals that contain ma…

continue reading.....

Recalls and Safety Alerts: Serious Complications from Using Recombinant Bone Morphogenetic Protein in the Cervical Spine

Published in September 30th, 2008
Posted by Food and Drug Adminstration (FDA): Patient Safety News in Safety Information
Comments Off

FDA is alerting healthcare professionals about reports of life-threatening complications from the use of recombinant human Bone Morphogenetic Protein (rhBMP) in cervical spine fusion. Although FDA has approved two rhBMP products for very specific me…

continue reading.....

Recalls and Safety Alerts: Avoiding Cardiotoxicity with Mitoxantrone

Published in September 30th, 2008
Posted by Food and Drug Adminstration (FDA): Patient Safety News in Safety Information
Comments Off

FDA is reemphasizing the importance of monitoring cardiac function in patients treated with mitozantrone, sold as Novantrone and also as a generic. Mitozantrone is used to treat certain patients with prostate cancer, leukemia and multiple sclerosis …

continue reading.....

Recalls and Safety Alerts: Update on Cardiopulmonary Reactions with Ultrasound Micro-bubble Contrast Agents

Published in September 30th, 2008
Posted by Food and Drug Adminstration (FDA): Patient Safety News in Safety Information
Comments Off

FDA is alerting healthcare professionals about labeling changes for ultrasound micro-bubble contrast agents, which are sold as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injec…

continue reading.....

Recalls and Safety Alerts: CT Scanning May Cause Malfunction of Electronic Medical Devices

Published in September 30th, 2008
Posted by Food and Drug Adminstration (FDA): Patient Safety News in Safety Information
Comments Off

FDA is alerting healthcare professionals that the x-rays emitted during CT exams may cause some electronic medical devices to malfunction. These malfunctions are different from those related to MRI scanning, which are caused by strong electrical and…

continue reading.....

Recalls and Safety Alerts: Warning on Tendon Injuries with Fluoroquinolone Antibiotics

Published in September 30th, 2008
Posted by Food and Drug Adminstration (FDA): Patient Safety News in Safety Information
Comments Off

FDA has asked that a boxed warning be added to the prescribing information for fluoroquinolone antibiotics. The warning will remind healthcare professionals that patients taking these drugs may experience an increased risk of tendinitis and tendon r…

continue reading.....

Class I Medical Device Recall: Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit

Published in September 30th, 2008
Posted by CDRH Consumer News in Medical Devices and Radiological Health
Comments Off

This recall is being conducted due to potential misconnections of the Medtronic sutureless connector (”SC”) catheters from the catheter port on the pump. These misconnections have resulted in a blockage (occlusion) between the sutureless pump connector…

continue reading.....

Registration and Listing (Device Establishment Registration and Listing for FY2009 Now Available)

Published in September 30th, 2008
Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health
Comments Off

Topics: Device Listing, Establishment Registration, Listing, Registration

continue reading.....

Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Written Comments

Published in September 30th, 2008
Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health
Comments Off

The committee will discuss general issues concerning the postmarket experience with various contact lens care products. The discussion will include recommendations on contact lens care product development topics such as preclinical testing and clini…

continue reading.....

Cancer Research UK and Astex Therapeutics join forces to develop new anti-cancer treatment

Published in September 30th, 2008
Posted by Pharmaceutical News Feed in Drugs and Food Information, Pharmaceutical Industry News
Comments Off

Cancer Research UK, Cancer Research Technology (CRT) - the charity’s development and commercialisation arm - and Astex Therapeutics Limited announced today that they have agreed to take into development a potential new anti-cancer treatment.

continue reading.....

« Older Entries