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U.S. Department of Health and Human Services

Safety

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Humatrope (somatropin [rDNA origin]) for injection

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

 

July 2014

Summary View

WARNINGS AND PRECAUTIONS

Neoplasms
  • In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GH deficiency and were treated with somatropin, an increased risk of a second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence Monitor all patients receiving somatropin therapy who have a history of GH deficiency secondary to an intracranial neoplasm for progression or recurrence of the tumor. Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, practitioners should thoroughly consider the risks and benefits of starting somatropin in these patients. If treatment with somatropin is initiated, these patients should be carefully monitored for development of neoplasms. Monitor patients receiving somatropin therapy carefully for increased growth, or potential malignant changes, of preexisting nevi

 

February 2011

Summary View

 

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

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 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