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Jamie Sheller
Jamie Sheller
Attorney • (800) 883-2299

Tendinitis and Tendon Rupture Lead to Black Box Warning

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An increased risk of tendinitis and tendon rupture has lead the FDA to seek a black box warning for fluoroquinolone antimicrobial drugs. The manufacturers of the drugs must also create a medication guide for patients, regarding the possible side effects. Even after more specific warnings about tendon risks were included on the drugs’ labels, the number of reports of tendon rupture did not decline. Therefore, the FDA is taking the step of requesting black box warnings. The drugs affected by this black box request include Cipro and Proquin brands ciprofloxacin, Factive brand gemifloxacin, Levaquin brand levofloxacin, Avelox brand moxifloxacin, Noroxin brand norfloxacin and Floxin brand ofloxacin. Fluoroquinolones are used to treat and prevent certain bacterial infections. These drugs are not used for viral infections, like the flu.

The risk of tendinitis and tendon rupture, while taking fluoroquinolones, is increased in patients with kidney, heart and lung transplants, those older than 60, and patients taking corticosteroid drugs. Symptoms include swelling, pain and inflammation of a tendon. In July, the FDA issued information to healthcare professionals regarding the black box warning and the possible side effects of fluoroquinolones.