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U.S. Department of Health and Human Services

Safety

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Omnitrope (somatropin [rDNA origin] injection)

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

 

August 2014

Summary View

WARNINGS AND PRECAUTIONS

Neoplasms
  • *revisions regarding an increased risk of developing a second neoplasm in childhood cancer survivors treated with radiation to the brain/head for their first neoplasm and who developed subsequent growth hormone deficiency and were treated with somatropin.*
     

 

April 2011

Summary View

 

5 WARNINGS AND PRECAUTIONS

5.14 Pancreatitis
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