Is it safe to use non-FDA (Food and Drug Administration) approved peptides in patients with a history of growth hormone deficiency or cancer?

Non-FDA Approved Peptides: Safety in Growth Hormone Deficiency and Cancer History

Non-FDA approved peptides should not be used in patients with growth hormone deficiency or cancer history—only FDA-approved recombinant human growth hormone (somatropin) products are appropriate for these populations, as they have established safety profiles and regulatory oversight. 1

Why FDA-Approved Products Are Essential

Established Safety in Cancer Survivors

• FDA-approved somatropin has not been shown to increase tumor recurrence risk in childhood cancer survivors (CCS) when used appropriately. 2
• Long-term surveillance data from biosimilar somatropin (Omnitrope®) in adults with GH deficiency showed a malignancy incidence rate of 7.94 per 1000 patient-years, with no general carcinogenic effect demonstrated. 3
• The most common cancers observed were basal cell carcinoma, prostate, breast, kidney, and melanoma—occurring after a mean of 79.4 months of treatment. 3

Critical Contraindications for Growth Hormone Therapy

• Somatropin is absolutely contraindicated in patients with active malignancy or evidence of progression or recurrence of an underlying tumor. 1
• Growth hormone therapy should not be initiated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure. 1
• Patients with diabetic retinopathy or uncontrolled diabetes require careful evaluation before initiating therapy. 1

Specific Risks of Non-FDA Approved Peptides

Lack of Quality Control and Monitoring

• Non-FDA approved peptides lack standardized manufacturing processes, purity testing, and batch-to-batch consistency that FDA-approved products undergo. 4
• There is no systematic post-marketing surveillance for adverse events or long-term safety outcomes with unapproved peptides. 3

Unknown Cancer Risk Profile

• While FDA-approved somatropin has been extensively studied in cancer survivors, non-approved peptides (such as growth hormone-releasing peptides or their analogues) have not undergone rigorous safety evaluation in this population. 5
• The theoretical concern remains that growth hormone and IGF-I can promote proliferation of both normal and malignant cells, making unregulated peptide use particularly dangerous. 6

Appropriate Management Algorithm

For Patients with Growth Hormone Deficiency and Cancer History:

Step 1: Assess Cancer Status

• Confirm complete remission with no evidence of active disease or progression. 1
• Document time since cancer treatment completion and type of malignancy. 2
• Evaluate for any predisposing factors for second malignancies (e.g., prior cranial irradiation). 7

Step 2: Risk Stratification

• High-risk patients (contraindicated for any GH therapy): Active malignancy, recent cancer diagnosis (<5 years for non-GI cancers), or evidence of tumor progression. 7, 1
• Moderate-risk patients (requires specialist evaluation): History of cranial irradiation (increased meningioma risk), previous leukemia, or colorectal cancer history. 2, 6
• Lower-risk patients (may be candidates): Remote cancer history (>5 years), complete remission, no high-risk features. 3

Step 3: If Treatment Indicated, Use Only FDA-Approved Products

• Prescribe FDA-approved somatropin products (e.g., Omnitrope®, Zorbtive) at appropriate dosing. 1
• For pediatric GHD: 0.03 mg/kg/day subcutaneously. 1
• For adult GHD: Start at 0.04 mg/kg/week for first month, then 0.08 mg/kg/week. 1

Step 4: Implement Rigorous Monitoring

• Monitor IGF-I levels to ensure physiologic replacement (not supraphysiologic levels). 1
• Conduct regular cancer surveillance appropriate to the patient's cancer history. 3
• Screen for new malignancies, particularly meningiomas in patients with prior cranial irradiation. 2
• Discontinue therapy immediately if malignancy is detected. 3

Special Considerations for Specific Cancer Types

Childhood Cancer Survivors

• GH replacement may be considered in CCS with documented GHD, as benefits to bone health and quality of life can outweigh risks when properly monitored. 7
• However, GH appears relatively weak as bone-targeted therapy outside the GHD setting, so benefits must clearly justify risks and costs. 7
• Testosterone or estrogen replacement may be more appropriate for addressing bone health in some survivors with gonadal insufficiency. 7

Gastrointestinal Malignancies

• Teduglutide (GLP-2 analogue) is contraindicated in patients with active gastrointestinal malignancies and can accelerate polyp and cancer growth. 7
• Patients should undergo colonoscopy screening before initiating teduglutide and periodically during therapy. 7
• Teduglutide should not be used in patients with active or recent (within 5 years) malignancy, regardless of location. 7

Neuroendocrine Tumors

• Somatostatin analogues (octreotide, lanreotide) are FDA-approved peptides used therapeutically in neuroendocrine tumors and have antiproliferative effects. 7
• These represent appropriate peptide therapy when indicated, unlike non-approved growth hormone-releasing peptides. 8

Common Pitfalls to Avoid

• Never substitute non-FDA approved peptides for legitimate GH deficiency treatment—the lack of regulatory oversight creates unacceptable risk. 1, 4
• Do not assume that "natural" or "bioidentical" peptides are safer—they lack quality control and safety data. 4
• Avoid initiating any growth hormone therapy without confirming cancer remission status—active malignancy is an absolute contraindication. 1
• Do not use growth hormone therapy primarily for bone health outside the GHD setting—the risks outweigh benefits. 7
• Never continue GH therapy if new malignancy is detected—immediate discontinuation is required. 3