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Boxed Warning Added to Fluoroquinolone Labels
The Food and Drug Administration is requiring makers of systemic fluoroquinolone antibiotics to add a boxed warning to the drugs' labels about possible tendonitis and tendon rupture. The drug makers also must produce and distribute a medication guide for patients.
Use of systemic fluoroquinolones increases the risk of tendonitis and tendon rupture, especially in patients older than age 60; patients who've had kidney, heart, or lung transplants; and patients who take corticosteroids. At the first sign of tendon pain, swelling, or inflammation, patients should stop taking the fluoroquinolone, stop using the affected area, and contact the prescriber about changing to a non-fluoroquinolone antibiotic.
Fluoroquinolone antibiotics include ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin. The boxed warning about risks of tendonitis and tendon rupture applies to capsules, tablets, and injectable forms of these drugs.
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