Are there black box warnings on testosterone medications?

Black Box Warnings on Testosterone Medications

Yes, testosterone medications do have black box warnings that primarily address the risk of secondary exposure to women and children, which can cause virilization. 1

Types of Black Box Warnings on Testosterone Products

The FDA has mandated black box warnings on testosterone products that focus on:

1. Secondary exposure risk: Virilization has been reported in children who were secondarily exposed to testosterone gel through skin contact with application sites on adults using these products 1

2. Safety precautions: The warnings emphasize that:

   • Children should avoid contact with unwashed or unclothed application sites
   • Patients must strictly adhere to recommended instructions for use
   • Healthcare providers should counsel patients about proper application and handling 1

Specific Formulations and Associated Risks

Different testosterone formulations carry different risk profiles:

Topical Preparations (Gels/Solutions)

• Highest risk for secondary transfer to women and children 2
• Can be inadvertently transferred through prolonged skin contact
• Require careful application and washing of hands after use
• Application sites should remain covered 2

Injectable Testosterone

• No risk of secondary transfer but associated with:
  • Higher risk of erythrocytosis (43.8% vs 15.4% with patches) 2
  • Fluctuating testosterone levels with peaks and valleys 2
  • Potentially greater risk of cardiovascular events compared to gels 2

Testosterone Patches

• Lower risk of secondary transfer
• May cause skin irritation at application site
• Less fluctuation in testosterone levels than injections 2

Additional Safety Concerns

Beyond the black box warnings, other safety concerns with testosterone therapy include:

1. Cardiovascular risk: In 2015, the FDA required labeling changes to inform about possible increased risk of heart attack and stroke with testosterone use for age-related hypogonadism 2

2. Fertility impact: Exogenous testosterone therapy can interrupt normal spermatogenesis and should not be prescribed to men trying to conceive 2

3. Erythrocytosis: Common side effect, especially with injectable formulations, requiring monitoring of hematocrit 2

4. Prostate concerns: Theoretical risk of exacerbating prostate cancer or benign prostatic hyperplasia 2

Clinical Implications and Monitoring

When prescribing testosterone:

• Choose appropriate formulation based on patient factors and risk profile
• Monitor hematocrit/hemoglobin regularly, especially with injectable formulations
• Measure testosterone levels every 6-12 months during treatment
• Target testosterone levels to the normal physiologic range (450-600 ng/dL) 2
• Counsel patients about proper application techniques and precautions to prevent secondary exposure
• Consider waiting period of 3-6 months after cardiovascular events before initiating therapy 2

Important Caveats

• Avoid alkylated oral testosterone (e.g., methyl testosterone) due to risk of liver toxicity 2
• Use commercially manufactured products rather than compounded testosterone when possible 2
• Consider alternative therapies (aromatase inhibitors, hCG, SERMs) for men wishing to preserve fertility 2
• Reassess need for therapy if patients don't experience symptomatic relief after reaching target testosterone levels 2

Black box warnings represent the FDA's strongest safety alert and should be carefully considered when prescribing testosterone therapy, with particular attention to preventing secondary exposure to women and children.