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FDA MedWatch
FDA MedWatch Safety Alerts
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. Electronic Medical Devices Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices. Sodium Polystyrene Sulfonate Suspension Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. Avastin (bevacizumab) Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination. 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.