FDA Safety Information

Fluoroquinolone Antimicrobial Drugs Increase Risk of Tendinitis

Fluoroquinolone Antimicrobial Drugs: FDA notified health care professionals that a boxed warning and medication guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use. This risk is further increased in those over age 60; in kidney, heart, and lung transplant recipients; and with use of concomitant steroid therapy. Physicians should advise patients at the first sign of tendon pain, swelling, or inflammation to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their prescribing doctor about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria.

Read the complete MedWatch 2008 Safety Summary.

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