Label Changes for:

Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules

June 2008

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


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

  • Clinical Trial Data Sources
  • Adverse Reactions Reported as Reasons for Discontinuation of Treatment in Placebo-Controlled Trials
    • Fibromyalgia (new subsection)
  • Adverse Reactions Occurring at an Incidence of 2% or More Among Duloxetine-Treated Patients in Placebo-Controlled Trials
    • Fibromyalgia (new subsection)
      • Table 5
  • Weight Changes

USE IN SPECIFIC POPULATIONS

  • Geriatric Use

WARNING AND PRECAUTIONS

Hepatotoxicity

There have been reports of hepatic failure, sometimes fatal, in patients treated with Cymbalta...

...Cymbalta should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established..

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