Label Changes for:

Levaquin (levofloxacin) Tablets and Oral Solution

April 2008

Changes have been made to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.


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

  • Hepatotoxicity

ADVERSE REACTIONS

  • Serious and Otherwise Important Adverse Reactions
    • Hepatotoxicity...

USE IN SPECIFIC POPULATIONS

  • Geriatric Use
    • Severe, and sometimes fatal, cases of hepatotoxicity have been reported postmarketing in association with Levaquin...

PATIENT COUNSELING INFORMATION

  • Serious and Potentially Serious
    Adverse Reactions
    • Hepatotoxicity

PATIENT PACKAGE INSERT

  • What are possible side effects of Levaquin?
    • Hepatotoxicity (liver damage)...

WARNINGS AND PRECAUTIONS

Postmarketing reports of severe hepatotoxicity (including acute hepatitis and fatal events) have been received for patients treated with Levaquin. No evidence of serious drug-associated hepatotoxicity was detected in clinical trials of over 7,000 patients. Severe hepatotoxicity generally occurred within 14 days of initiation of therapy and most cases occurred within 6 days. Most cases of severe hepatotoxicity were not associated with hypersensitivity [see Warnings and Precautions (5.2)]. The majority of fatal hepatotoxicity reports occurred in patients, 65 years of age or older and most were not associated with hypersensitivity. Levaquin should be discontinued immediately if the patient develops signs and symptoms of hepatitis...

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