What are the risks of using testosterone cream in an elderly male with potential underlying medical conditions, such as elevated prostate-specific antigen (PSA) levels and impaired lipid profiles?

Risks of Testosterone Cream in Elderly Males

Yes, testosterone cream carries several significant risks in elderly males, particularly erythrocytosis (elevated red blood cell count), potential cardiovascular events, and prostate-related concerns, though transdermal formulations like creams appear safer than injectable forms for some of these risks. 1

Primary Hematologic Risk: Erythrocytosis

Polycythemia/erythrocytosis is the most common and clinically significant risk, though transdermal testosterone (creams/gels) carries substantially lower risk than injections 1:

• Transdermal preparations cause erythrocytosis in 2.8-17.9% of patients (dose-dependent), compared to 43.8% with intramuscular injections 1, 2
• In elderly men, elevated hematocrit is particularly dangerous because increased blood viscosity can aggravate coronary, cerebrovascular, or peripheral vascular disease 1
• The risk is compounded if the patient has conditions like COPD that independently raise hematocrit 1
• Hematocrit must be monitored regularly, with intervention (dose reduction, withholding therapy, or phlebotomy) if levels exceed 52% 1, 2

Cardiovascular Concerns

Long-term cardiovascular safety remains inadequately established in elderly men 1, 3:

• The FDA acknowledges insufficient long-term safety data in geriatric patients to assess cardiovascular disease risk 3
• Some post-marketing studies suggest increased risk of myocardial infarction and stroke, though evidence is conflicting 3
• The FDA mandated the TRAVERSE trial (ongoing through 2023) specifically to evaluate cardiovascular outcomes in older men 1
• Venous thromboembolism (VTE), including DVT and pulmonary embolism, has been reported in patients using testosterone products 3

Prostate-Related Risks

Prostate monitoring is essential, though definitive cancer risk remains unproven 1:

• Benign prostatic hyperplasia (BPH) symptoms may worsen, requiring monitoring 1, 3
• Theoretical risk of stimulating occult prostate cancer exists, though not definitively proven 1
• Testosterone is absolutely contraindicated in men with known or suspected prostate cancer 3
• Regular PSA testing and digital rectal examination are mandatory, especially in men over 50 2, 4, 3

Additional Risks Specific to Elderly Males

Sleep apnea may develop or worsen in predisposed individuals, a particular concern in older men 1, 3

Fluid retention can occur, which may precipitate or worsen congestive heart failure in elderly men with preexisting cardiac, renal, or hepatic disease 1, 3

Testicular atrophy and infertility occur due to suppression of the hypothalamic-pituitary-gonadal axis 1, 2

Lipid Profile Considerations

Regarding your concern about impaired lipid profiles: testosterone cream has a neutral effect 1:

• Multiple studies show transdermal testosterone does not significantly worsen lipid profiles when used at physiologic replacement doses 1
• A 36-month placebo-controlled study found no significant differences in lipid or apolipoprotein levels with transdermal testosterone 1
• This is reassuring for elderly men with baseline dyslipidemia 1

PSA Elevation Context

For your specific concern about elevated PSA 2, 4:

• PSA elevation is the most common adverse reaction (≥5% incidence) with testosterone therapy 3
• Baseline PSA must be checked before initiating therapy 2, 4
• Treatment should not be initiated if PSA is elevated without urologic evaluation 2, 4
• Regular monitoring is non-negotiable during treatment 2, 4, 3

Critical Monitoring Requirements

Mandatory monitoring parameters for elderly men on testosterone cream 2, 4, 3:

• Hematocrit/hemoglobin: Check regularly to detect erythrocytosis early 1, 2, 3
• PSA and digital rectal exam: Particularly in men over 50 2, 4, 3
• Testosterone levels: Measure at approximately 14 and 28 days after starting, then periodically 3
• Blood pressure: Monitor for increases 1, 3
• Liver function tests and lipid concentrations: Periodic assessment 3

Important Caveats for Elderly Patients

The evidence base for elderly men is limited 1, 3:

• Most trials excluded men at highest risk for adverse events (recent cardiovascular events, elevated PSA, history of prostate cancer) 1
• Few trials exceeded 1 year duration, limiting conclusions about long-term safety 1
• Benefits beyond sexual function are modest in elderly men without organic hypogonadism 1

Testosterone should not be used for "age-related hypogonadism" alone without documented low testosterone (<275-300 ng/dL on two morning measurements) AND associated symptoms 1

Transdermal-Specific Safety Concern

Risk of secondary exposure to women and children through skin contact 1, 3:

• Can cause virilization in women and children 1, 3
• Application site must be covered with clothing after drying 3
• Wash application site thoroughly with soap and water before any skin-to-skin contact 3
• Apply only to shoulders and upper arms, never to genitals, chest, abdomen, or axillae 3