Posts Tagged ‘ risk evaluation ’

FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs

Jul 8th, 2008 | By admin | Category: Safety News

The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary.
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FDA Approves Entereg to Help Restore Bowel Function Following Surgery

May 20th, 2008 | By admin | Category: Health News

The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.