From the Guidelines
Testosterone therapy is associated with several risks, including cardiovascular problems, sleep apnea, and prostate issues, and should be carefully considered and monitored in patients with low testosterone levels. The risks of testosterone therapy include:
- Cardiovascular problems, such as heart attack, stroke, and blood clots, particularly in men with existing heart disease 1
- Worsening of sleep apnea, a potentially serious sleep disorder 1
- Stimulation of noncancerous growth of the prostate (benign prostatic hyperplasia) and potential promotion of growth of existing prostate cancer 1
- Acne and other skin reactions, limited sperm production (potentially causing infertility), shrinkage of testicles, and enlargement of breasts in men 1
- Increased risk of polycythemia, a dangerous increase in red blood cell count, which requires regular blood tests to monitor 1
- Mood swings, aggression, and liver problems 1 It is essential to weigh the benefits of addressing testosterone deficiency against these potential risks and to conduct comprehensive evaluation, including prostate screening and cardiovascular risk assessment, before starting testosterone therapy 1. Regular monitoring is also crucial throughout treatment to minimize the risks associated with testosterone therapy.
From the FDA Drug Label
Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with use of testosterone replacement therapy. Exogenous administration of androgens may lead to azoospermia. Edema with or without congestive heart failure (CHF) may be a complication in patients with preexisting cardiac, renal, or hepatic disease. Sleep apnea may occur in those with risk factors.
The risks of testosterone include:
- Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE)
- Myocardial infarction and stroke
- Azoospermia (low sperm count)
- Edema with or without congestive heart failure (CHF)
- Sleep apnea 2 2
From the Research
Risks of Testosterone Therapy
The risks associated with testosterone therapy are numerous and have been documented in several studies 3, 4, 5, 6, 7. Some of the potential risks include:
- Cardiovascular complications, as warned by the U.S. Food and Drug Administration 3
- Rising prostate-specific antigen levels 3, 4
- Worsening lower urinary tract symptoms 3
- Polycythemia, which is an increase in red blood cell count 3, 5, 7
- Increased risk of venous thromboembolism 3, 7
- Erythrocytosis, which is an increase in hemoglobin and hematocrit levels 7
- Peripheral edema, cardiac and hepatic dysfunction 6
Contraindications and Monitoring
Testosterone therapy is contraindicated in men with untreated prostate and breast cancer 6. Patients receiving testosterone therapy should be monitored regularly to ensure that testosterone levels rise appropriately, clinical improvement occurs, and no complications develop 3, 4. This monitoring should include regular measurements of testosterone, haematocrit, and PSA levels 4.
Potential Benefits and Risks
While testosterone therapy may have potential benefits such as increased libido, improved sexual function, improved mood and well-being, and increased muscle mass and bone density 3, the risks associated with it must be carefully considered. The evidence regarding the safety and utility of testosterone replacement therapy is equivocal, and there is a need for further research to fully evaluate the risks and benefits of this therapy 5.