Testosterone Replacement Therapy Adverse Effects
Testosterone replacement therapy carries risks related to prostate and breast safety, erythrocytosis, cardiovascular and thromboembolic events, and exacerbation of lower urinary tract symptoms and sleep-disordered breathing. (endocrine.org)
Prostate and Breast-Related Risks
Testosterone therapy should be avoided in men with breast cancer and in men with prostate cancer. (endocrine.org) Testosterone therapy should be avoided in men with a prostate-specific antigen (PSA) level >4 ng/mL. (endocrine.org) Testosterone therapy should be avoided in men with PSA >3 ng/mL plus increased prostate-cancer risk without further urologic evaluation. (endocrine.org) Testosterone therapy is associated with monitored changes in PSA during the first year. (endocrine.org) A confirmed PSA rise >1.4 ng/mL above baseline during the first 12 months warrants urologic consultation. (endocrine.org) A confirmed PSA >4.0 ng/mL during the first 12 months warrants urologic consultation. (endocrine.org) Prostate monitoring should conform to standard prostate-cancer screening guidelines after 1 year of therapy. (endocrine.org)
Erythrocytosis Risk
Testosterone therapy should be avoided in men with elevated hematocrit. (endocrine.org) Testosterone therapy should include assessment for adverse effects after initiation. (endocrine.org)
Cardiovascular and Thromboembolic Risks
In TRAVERSE, testosterone replacement therapy was noninferior to placebo for the incidence of major adverse cardiac events (7.0% with testosterone vs 7.3% with placebo; hazard ratio 0.96; 95% CI 0.78 to 1.17). (nejm.org) In TRAVERSE, venous thromboembolic events were more common with testosterone than placebo, including higher pulmonary embolism incidence in the testosterone group. (nejm.org) Testosterone therapy should be avoided in men with thrombophilia. (endocrine.org) Testosterone therapy should be avoided in men with myocardial infarction or stroke within the last 6 months. (endocrine.org)
Lower Urinary Tract Symptoms and Sleep Apnea Risks
Testosterone therapy should be avoided in men with severe lower urinary tract symptoms. (endocrine.org) Testosterone therapy should be avoided in men with untreated severe obstructive sleep apnea. (endocrine.org)
Contraindications That Identify Higher-Risk Situations
Testosterone therapy should not be initiated when planning fertility in the near term. (endocrine.org) Testosterone therapy should be avoided in men with uncontrolled heart failure. (endocrine.org)
Monitoring-Related Harms Avoidance
A standardized monitoring plan is required after initiation to assess response, adherence, and adverse effects. (endocrine.org) A urological consultation is recommended during the first year for PSA increases meeting Endocrine Society criteria or abnormal prostate exam findings. (endocrine.org)
Regulatory and Labeling Considerations
The FDA requested label updates after TRAVERSE, concluding that the limitation of use regarding men with age-related hypogonadism is no longer warranted based on the available evidence that major adverse cardiovascular events were not meaningfully increased. (hhs.gov) The FDA requested updates to longstanding safety information related to prostate health, noting that current labeling generally states testosterone should not be used in men with known or suspected prostate cancer and that uncertainty remains for long-term effects. (hhs.gov)