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July 8, 2008: FDA Warns of Levaquin Tendon Injury Risk

Levaquin Tendon Injury News

As of July 8, 2008, the FDA has alerted doctors and patients of the increased risk of developing tendinitis and tendon rupture associated with systemic use of quinolone antibiotics like Levaquin. The FDA estimates that spontaneous ruptures occur in about one in 100,000 people, and that quinolone use appears to triple or quadruple the risk of injury. In response to this risk, the FDA has required labeling for Levaquin and other quinolone antibiotics to now include a “Boxed Warning,” which is the strongest warning that the FDA can require a prescription drug to include in its labeling.

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Symptoms Of Levaquin Tendon Injury

A ruptured tendon is a serious injury resulting in excruciating pain and disability if left untreated. Tendinitis is an inflammation or irritation of a tendon, causing substantial tenderness and pain.

Symptoms of tendon injury include:
• Pain, swelling or inflammation in a tendon area
• A snap or pop in a tendon area
• Bruising right after an injury in a tendon area
• Inability to move the affected area or bear weight

Information on Levaquin Tendon Injury Risk

The risk of quinolone tendon injury is further increased in patients over 60 years of age; who are kidney, heart, and lung transplant recipients; or receiving concomitant steroid therapy.

Quinolone antibiotics include:
• ciprofloxacin (Cipro, Cipro XR, Proquin XR),
• gemifloxacin (Factive),
• levofloxacin (Levaquin),
• moxifloxacin (Avelox),
• norfloxacin (Noroxin),
• ofloxacin (Floxin).

Quinolone and Levaquin Tendon Injury Risk Leads to Labeling Change

The FDA mandated the Boxed Warning in response to an increasing number of complaints regarding tendonitis and ruptured tendons associated with Levaquin and quinolone antibiotic use.

Pharmaceutical companies are also required to develop a Medication Guide for patients regarding possible quinolone side effects.

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