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U.S. Department of Health and Human Services

Safety

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Gemzar (Gemcitabine for injection), 1 g and 200 mg

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

 

May 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.0 Posterior Reversible Encephalopathy Syndrome...added section
5.8 Capillary Leak Syndrome...added section

6 ADVERSE REACTIONS

  • Addition of Posterior Reversible Encephalopathy Syndrome to the list of serious adverse reactions [see Warnings and Precautions 5.9)]

 

May 2013

Summary View

5 WARNINGS AND PRECAUTIONS

5.8 Capillary Leak Syndrome
  • Capillary leak syndrome (CLS) with severe consequences has been reported in patients receiving Gemzar as a single agent or in combination with other chemotherapeutic agents. Discontinue Gemzar if CLS develops during therapy

6 ADVERSE REACTIONS

6.2 Post-Marketing Experience
  • added: Vascular Disorders — Peripheral vasculitis, gangrene, and capillary leak syndrome [see Warnings and Precautions (5.9)]