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
