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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) 

 

August 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Peripheral Neuropathy
  • Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including Levaquin…
 

ADVERSE REACTIONS

Serious and Otherwise Important Adverse Reactions
  • Peripheral Neuropathy that may be irreversible
Postmarketing Experience
Nervous Disorders
  • Peripheral neuropathy (that may be irreversible)
 

MEDICATION GUIDE

What are the possible side effects of Levaquin?
  • Changes in sensation and nerve damage (Peripheral Neuropathy) - Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including Levaquin…

 

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.