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U.S. Department of Health and Human Services

Safety

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Nutropin (Somatropin [rDNA origin]) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Pancreatitis
  • Cases of pancreatitis have been reported rarely in children and adults receiving somatropin treatment, with some evidence supporting a greater risk in children compared with adults. Published literature indicates that girls who have TS may be at greater risk than other somatropin-treated children. Pancreatitis should be considered in any somatropin–treated patient, especially a child, who develops persistent severe abdominal pain.
 
ADVERSE REACTIONS
Most Serious and/or Most Frequent Observed Adverse Reactions
  • Pancreatitis [see Warnings and Precautions (5.15)]       
 
Post-Marketing Experience
The following additional adverse reactions have been reported in GH-treated patients:
  • Pancreatitis