FDA News Alerts


FDA News Alerts	Send to a Friend	Print This Page

Safety Alerts on Drugs from the U.S. Food and Drug Administration's MedWatch: Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) 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 Electronic Medical Devices 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 Sodium Polystyrene Sulfonate Suspension 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 Avastin (bevacizumab) Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination. Mon, 14 Jul 2008 14:30:00 EDT May 2008 Monthly Safety Labeling 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 Herceptin 440 mg Vials and BWFI Diluent 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 Fluoroquinolone Antimicrobial Drugs 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 Rize 2 The Occasion Capsules and Rose 4 Her Capsules Certain lots of both products were recalled because they contained an undeclared ingredient. Wed, 02 Jul 2008 16:13:00 EDT Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion 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 Myfortic (mycophenolate acid) 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 July 2008 Patient Safety News 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 April 2008 Monthly Safety Labeling 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 March 2008 Monthly Safety Labeling 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 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product Product recalled due to the presence of Burkholderia cepacia. Mon, 30 Jun 2008 17:22:00 EDT Current Alerts Recall Notices Sign up to receive notices via e-mail

280 Calhoun Street, PO Box 250140, Charleston, SC 29425 | 866.200.1968 toll-free | 843.792.2620 fx