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U.S. Department of Health and Human Services

Safety

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Cymbalta (duloxetine hydrochloride)

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

 

September 2011

Summary View

WARNINGS and PRECAUTIONS

Severe Skin Reactions
  • Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur with Cymbalta. The reporting rate of SJS associated with Cymbalta use exceeds the general population background incidence rate for this serious skin reaction (1 to 2 cases per million person years). The reporting rate is generally accepted to be an underestimate due to underreporting.
  • Cymbalta should be discontinued at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified

MEDICATION GUIDE

  • add severe skin reactions language

 

April 2011

Summary View

 

6 ADVERSE REACTIONS

6.12 Postmarketing Spontaneous Reports
  • several adverse reactions added

8 USE IN SPECIAL POPULATIONS

8.1 Pregnancy
  • information added about pregnancy registry

17 PATIENT INFORMATION

17.8 Pregnancy and Breast Feeding
  • information added about pregnancy registry