Commentary by Marilena S. Antonopoulos, PharmD, Pharmacology Editor
On July 8th, the FDA notified the manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling and a Medication Guide for patients concerning the increased risk of tendinitis and tendon rupture is necessary. The FDA conducted a new analysis of the available literature and post-marketing adverse event reports which reconfirms that the use of fluoroquinolones is associated with an increased risk of tendon rupture.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60 years, in those taking corticosteroid drugs, and in kidney, heart and lung transplant recipients. Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation.
Tendinitis and tendon rupture most frequently involve the Achilles tendon. Tendinitis and tendon rupture in the rotator cuff, the hand, the biceps and the thumb have also been reported. Tendon rupture can occur during or after completion of fluoroquinolone use, with cases reportedly occurring up to several months after completion of therapy.
These warnings would apply to fluoroquinolones for systemic use (e.g., pills, tablets, capsules and injectable formulations). The warnings would not apply to fluoroquinolones for topical ophthalmic or otic use (e.g., eye and ear drops). Medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin) and Floxin and generic ofloxacin.