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U.S. Department of Health and Human Services

Safety

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Levaquin (levofloxacin) Injection, for Intravenous Use May 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

Tendon Effects

...Postmarketing surveillance reports indicate that this risk is increased in patients receiving concomitant corticosteroids and in patients over 65 years of age. Levaquin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon...

Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals

Levaquin is indicated in pediatric patients (less than 18 years of age) only for the prevention of inhalational anthrax (post-exposure)...

WARNINGS AND PRECAUTIONS

  • Tendon Effects
  • Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals

USE IN SPECIFIC POPULATIONS

  • Pediatric Use
    • Inhalational Anthrax (Post-Exposure)
    • Adverse Events

PATIENT COUNSELING INFORMATION

  • Serious and Potentially Serious Adverse Reactions
    • Musculoskeletal Disorders in Pediatric Patients

PATIENT PACKAGE INSERT

  • Who should not take Levaquin?
  • What if I have been prescribed Levaquin for possible anthrax exposure?

 

Label approved 05/05/2008 is not available on Drugs@FDA