From the Guidelines
Growth hormone injections are associated with several safety concerns, including increased risk of slipped capital femoral epiphysis, intracranial hypertension, and potential effects on renal function, which necessitate careful monitoring and consideration of the benefits and risks in individual patients. The safety concerns associated with recombinant human Growth Hormone (GH) injections are a critical consideration in the management of patients with growth hormone deficiency or other conditions where GH therapy is indicated. According to the clinical practice recommendations for growth hormone treatment in children with chronic kidney disease 1, GH therapy can contribute to an increased risk of slipped capital femoral epiphysis, highlighting the need for careful monitoring and discontinuation of GH therapy if symptoms occur.
Key safety concerns and recommendations for GH therapy include:
- Monitoring for slipped capital femoral epiphysis, particularly if symptoms such as hip or knee pain occur, and discontinuing GH therapy if a diagnosis is confirmed 1
- Regular assessment of renal function, as GH therapy may affect kidney function, particularly in patients with chronic kidney disease 1
- Monitoring for intracranial hypertension, as GH therapy can increase the risk of this condition 1
- Careful consideration of the benefits and risks of GH therapy in individual patients, taking into account factors such as growth potential, nutritional status, and presence of other medical conditions 1
Overall, while GH injections can be an effective treatment for growth hormone deficiency and other conditions, careful monitoring and consideration of the potential safety concerns are essential to minimize the risk of adverse effects and optimize treatment outcomes. Regular monitoring through blood tests and physical examinations, as well as careful consideration of the benefits and risks of GH therapy, are critical components of safe and effective GH treatment.
From the FDA Drug Label
5.15 Laboratory Tests Serum levels of inorganic phosphorus, alkaline phosphatase, and parathyroid hormone (PTH), and IGF-1 may increase during somatropin therapy. 5.16 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. 6 ADVERSE REACTIONS The following important adverse reactions are also described elsewhere in the labeling: Increased mortality in patients with acute critical illness [see Warnings and Precautions (5. 1)] Fatalities in children with Prader-Willi syndrome [see Warnings and Precautions (5.2)] Neoplasms in pediatric patients [see Warnings and Precautions (5.3)] Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4)] Intracranial hypertension [see Warnings and Precautions (5.5)] Severe hypersensitivity [see Warnings and Precautions (5. 6)] Fluid retention [see Warnings and Precautions (5.7)] Hypoadrenalism [see Warnings and Precautions (5.8)] Hypothyroidism [see Warnings and Precautions (5.9)] Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions (5.10)] Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions (5. 11)] Otitis media and cardiovascular disorders in patients with Turner syndrome [see Warnings and Precautions (5.12)] Osteodystrophy in pediatric patients with chronic kidney disease [see Warnings and Precautions (5.13)] Lipoatrophy [see Warnings and Precautions (5.14)] Pancreatitis [see Warnings and Precautions (5.16)]
The safety concerns associated with recombinant human Growth Hormone (GH) injections include:
- Increased risk of pancreatitis, particularly in children
- Neoplasms in pediatric patients
- Glucose intolerance and diabetes mellitus
- Intracranial hypertension
- Severe hypersensitivity
- Fluid retention
- Hypoadrenalism
- Hypothyroidism
- Slipped capital femoral epiphysis in pediatric patients
- Progression of preexisting scoliosis in pediatric patients
- Otitis media and cardiovascular disorders in patients with Turner syndrome
- Osteodystrophy in pediatric patients with chronic kidney disease
- Lipoatrophy
- Increased mortality in patients with acute critical illness
- Fatalities in children with Prader-Willi syndrome 2
From the Research
Safety Concerns Associated with Recombinant Human Growth Hormone (GH) Injections
- The safety profile of GH treatment has been found to be generally good, but concerns about increased mortality risk in adulthood have been raised 3.
- Long-term safety issues of recombinant human growth hormone (rhGH) are a concern, particularly related to the proliferative actions of GH that could increase the risk of tumor recurrence or induce the development of new benign and malignant tumors 4.
- Adverse reactions of rhGH therapy include:
- Intracranial hypertension
- Fluid retention
- Glucose intolerance
- Worsening of scoliosis and slipped capital femoral epiphysis in children
- Increased risk for intracranial tumors in teenagers and young adults treated with radiation to the head as children for a first neoplasm 5.
- The use of GH at replacement doses in children with GH deficiency has resulted in rare and generally reversible adverse effects, but the long-term administration of pharmacologic GH doses to short, mostly non-GH-deficient children must be viewed with caution, as long-term complications cannot as yet be fully evaluated 6.
- No adverse reactions to the treatment were recorded in a Chinese multicentre trial of recombinant somatropin for 1 year 7.
- A significant inverse relationship with GH dose was shown for adverse drug reactions (ADRs) and serious adverse events (SAEs) incidence rates in the low-risk group and the non-SGA subgroup, and for SAEs in the intermediate- and high-risk groups 3.