July 31, 2008Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) 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. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Mitoxantrone Hydrochloride (marketed as Novantrone and generics) Post-marketing safety study shows poor adherence to cardiac monitoring recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to recommendations for patients with MS. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. New Medical Products: New Non-Refrigerated Coagulation Product FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with... Living with Fibromyalgia, Drugs Approved to Manage Pain A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Warning for Regranex—Cream for Leg and Foot Ulcers A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. # posted by Network @ 2:01 AM
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