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U.S. Department of Health and Human Services

Safety

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Levaquin (Levofloxacin) Tablets, Oral Solution and Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Aninmals
  • Levaquin is indicated in pediatric patients (6 months of age and older) only for the prevention of inhalational anthrax (post-exposure) and for plague. An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) compared to controls has been observed in pediatric patients receiving Levaquin.

 

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