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FDA Warns That Levaquin And Other Quinolones Are Linked To Tendon Injuries
As of July 8, 2008, the FDA has required labeling for Levaquin and other quinolone antibiotics to include a “Boxed Warning,” alerting doctors and patients of the increased risk of developing tendinitis and tendon rupture associated with systemic use of these antibiotics. A Boxed Warning is the strongest warning that the FDA can require a prescription drug to include in its labeling.
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), and ofloxacin (Floxin). Levaquin And Quinolone 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.
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. Most of the tendinitis and tendon ruptures have involved the Achilles tendon, the body’s strongest tendon, which passes behind the ankle. However, FDA has also received reports of tendinitis and ruptures in the shoulder and hand. Levaquin And Quinolone Antibiotic Therapy
Levaquin and quinolones are antibiotics, prescribed in adults to treat lung, sinus, skin, prostate and urinary tract infections caused bacteria. Levaquin and quinolones are not prescribed to treat viral infections such as a cold or the flu. What Your Tendons Do For You
A tendon is a tough band of tissue that connects your muscles to your bones. Tendons help move skeletal bones by transmitting a force on the bones as the muscle contracts. 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 Rupture
• 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 weightWhat You Should Do If You Suspect A Levaquin Or Quinolone Tendon Injury
The FDA advises consumers to contact their health care professional if they experience symptoms associated with Levaquin or fluoroquinalone tendon injury. They also encourage consumers and professionals to report suspected Levaquin or quinolone antibiotic side effects or product quality problems to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch/report.htm
, or by phone 800-FDA-1088.
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