Label Changes for:

Humatrope (somatropin [rDNA origin]) for injection

July 2010

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) – July 2010 and February 2011

February 2011

 

WARNINGS AND PRECAUTIONS

Glucose Intolerance and Diabetes Mellitus
  • ..and new onset type 2 diabetes mellitus has been reported in patients taking somatropin

ADVERSE REACTIONS

Postmarketing Experience
  • New-onset type 2 diabetes mellitus in children and adults

 

July 2010

 

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 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 abdominal pain.

ADVERSE REACTIONS

Most Serious and/or Most Frequently Observed Adverse Reactions
  • Pancreatitis
Post-Marketing Experience
  • In an ongoing post-marketing observational study of somatropin treatment in 3,102 GH-deficient adults, hypertension, dyspnea, and sleep apnea were reported by 1% to less than 10% of patients after various durations of treatment.
Gastrointestinal 
  •  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 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 abdominal pain

 

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