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FDA Lawsuit


Anitmocribials to Carry a Boxed Warning About Risk for Tendinitis and Tendon Rupture


Warnings for Fluoroquinolone Antimicrobial Drugs Increased

FDA Adds Boxed Warning About Increased Risk of Tendinitis and Tendon Rupture

FDA notified healthcare 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.

Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. 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 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.

JUL-08-08: Fluoroquinolone Antimicrobial Drugs [FDA: FLUOROQUINOLONE ANTIMICROBIAL DRUGS]

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