FDA MedWatch Safety Alerts http://www.fda.gov/medwatch en-us Thu, 17 Jul 2008 15:45:00 EDT jay.wattenberg@fda.hhs.gov Radiological healthcare professionals, cardiologists, hospital risk managers Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. Thu, 17 Jul 2008 15:45:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#Microbubble http://www.fda.gov/medwatch/safety/2008/safety08.htm#Microbubble Radiologists, surgeons, hospital risk managers, other healthcare professionals Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices. Wed, 16 Jul 2008 14:30:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#ElectronicMedical http://www.fda.gov/medwatch/safety/2008/safety08.htm#ElectronicMedical Pharmacists, hospital risk managers, other healthcare professionals Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. Wed, 16 Jul 2008 14:30:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#SPSS http://www.fda.gov/medwatch/safety/2008/safety08.htm#SPSS Oncologists, other healthcare professionals Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination. Mon, 14 Jul 2008 14:30:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#Avastin http://www.fda.gov/medwatch/safety/2008/safety08.htm#Avastin Healthcare professionals Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Thu, 10 Jul 2008 15:09:00 EDT http://www.fda.gov/medwatch/safety/2008/may08_quickview.htm http://www.fda.gov/medwatch/safety/2008/may08_quickview.htm Healthcare professionals Complaints of damaged and broken vials of Herceptin 440 mg and BWFI diluent that may lead to a loss of sterility, which may cause infections in patients. Thu, 10 Jul 2008 13:14:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#Herceptin http://www.fda.gov/medwatch/safety/2008/safety08.htm#Herceptin Healthcare professionals, consumers BOXED WARNING and Medication Guide to be added to prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use. Tue, 08 Jul 2008 11:41:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fluoroquinolone http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fluoroquinolone Consumers, healthcare professionals Certain lots of both products were recalled because they contained an undeclared ingredient. Wed, 02 Jul 2008 16:13:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#Rize http://www.fda.gov/medwatch/safety/2008/safety08.htm#Rize Orthopedic surgeons, neurosurgeons, hospital risk managers, surgical service staff Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine. Wed, 02 Jul 2008 13:08:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#Protein http://www.fda.gov/medwatch/safety/2008/safety08.htm#Protein Transplantation specialists, infectious disease specialists, other healthcare professionals Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. Tue, 01 Jul 2008 16:09:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#mycophenolate http://www.fda.gov/medwatch/safety/2008/safety08.htm#mycophenolate Healthcare professionals Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Tue, 01 Jul 2008 14:24:00 EDT http://www.fda.gov/psn http://www.fda.gov/psn Healthcare professionals Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Tue, 01 Jul 2008 11:33:00 EDT http://www.fda.gov/medwatch/safety/2008/apr08_quickview.htm http://www.fda.gov/medwatch/safety/2008/apr08_quickview.htm Healthcare professionals Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Tue, 01 Jul 2008 11:33:00 EDT http://www.fda.gov/medwatch/safety/2008/mar08_quickview.htm http://www.fda.gov/medwatch/safety/2008/mar08_quickview.htm Hospital risk managers, pharmacists Product recalled due to the presence of Burkholderia cepacia. Mon, 30 Jun 2008 17:22:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#Chlorhexidine http://www.fda.gov/medwatch/safety/2008/safety08.htm#Chlorhexidine