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What's New

Abacavir (marketed as Ziagen) and Abacavir-containing Medications - Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment.
(Posted 07/24/2008)

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.
(Posted 07/17/2008)

Electronic Medical Devices - Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices.
(Posted 07/16/2008)

Sodium Polystyrene Sulfonate Suspension - Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised.
(Posted 07/16/2008)

Avastin (bevacizumab) and sunitinib malate - Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination.
(Posted 07/14/2008)

May 2008 Safety-Related Labeling Changes - Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.
(Posted 07/10/2008)

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.
(Posted 07/10/2008)

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.
(Posted 07/08/2008)
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Web page last revised by jlw July 24, 2008