Label Changes for:

Norditropin Cartridges (somatropin [rDNA origin] injection)

May 2011

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

WARNINGS AND PRECAUTIONS

Impaired Glucose Tolerance and Diabetes Mellitus
  • ...New-onset Type 2 diabetes mellitus has been reported.

Pancreatitis
  • Cases of 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 Turner syndrome 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

Postmarketing Experience
  • New-onset Type 2 diabetes mellitus has been reported
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