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U.S. Department of Health and Human Services

Safety

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Tev-Tropin (somatropin [rDNA origin]) for injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2011

 

Summary View

WARNINGS

  • Cases of pancreatitis have been reported rarely in children and adults.....
  • Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome,”  (characterized.....

PRECAUTIONS

General
  • Treatment with somatropin may decrease insulin sensitivity....

ADVERSE REACTIONS

  • New-onset type 2 diabetes mellitus has been reported
  • potential immunogenicity of therapeutic proteins