From the Guidelines
Testosterone replacement therapy for older or middle-aged men can cause several adverse effects, including increased risk of cardiovascular problems, sleep apnea, fluid retention, acne, gynecomastia, testicular shrinkage, reduced sperm production, and potential infertility, as well as prostate health concerns and blood abnormalities 1.
Adverse Effects of Testosterone Replacement Therapy
The use of testosterone in older or middle-aged men has been associated with various adverse effects that can impact morbidity, mortality, and quality of life. Some of the potential risks include:
- Increased risk of cardiovascular problems, including heart attack and stroke, especially in those with pre-existing heart disease 1
- Worsening of sleep apnea, fluid retention leading to swelling, and stimulation of acne or oily skin development 1
- Enlargement of breast tissue (gynecomastia), shrinkage of testicles, reduced sperm production, and potential infertility 1
- Prostate health concerns, including worsening of benign prostatic hyperplasia symptoms and potential stimulation of growth of existing prostate cancer 1
- Blood abnormalities, such as increased red blood cell count (polycythemia), which raises the risk of blood clots 1
- Mood swings, aggression, and other psychological effects 1
Importance of Medical Supervision
Given the potential risks associated with testosterone replacement therapy, it is essential for men to undergo regular monitoring through blood tests to check hormone levels, complete blood counts, and prostate-specific antigen levels 1. Proper medical supervision is crucial for anyone considering this treatment, especially those without a true medical deficiency, as the risks increase with age 1.
Recommendations for Testosterone Replacement Therapy
The American College of Physicians suggests that clinicians discuss the potential benefits, harms, costs, and patient's preferences before initiating testosterone treatment in men with age-related low testosterone and sexual dysfunction 1. Additionally, clinicians should reevaluate symptoms within 12 months and periodically thereafter, and discontinue testosterone treatment if there is no improvement in sexual function 1.
From the FDA Drug Label
8.5 Geriatric Use There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone gel 1.62% to determine whether efficacy in those over 65 years of age differs from younger subjects. Of the 234 patients enrolled in the clinical trial utilizing testosterone gel 1. 62%, 21 were over 65 years of age. Additionally, there is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH.
9.2 Abuse Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice Abuse-Related Adverse Reactions Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility
The adverse effects of using testosterone as an older or middle-aged man include:
- Cardiovascular risks: cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident
- Psychiatric manifestations: major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility, and aggression
- Other risks: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility
- Worsening of signs and symptoms of BPH 2 2
From the Research
Adverse Effects of Testosterone Replacement Therapy in Older or Middle-Aged Men
The use of testosterone as a replacement therapy in older or middle-aged men has been associated with several adverse effects. Some of the potential risks include:
- Increased risk of cardiovascular morbidity and mortality 3
- Prostate cancer, particularly in men with a history of prostate cancer 3
- Breast cancer, particularly in men with a history of breast cancer 3
- Myocardial infarction or stroke, particularly in men who have had these conditions within the last four months 3
- Severe or decompensated heart failure 3
- Suppression of spermatogenesis, which can affect fertility 4
- Hepatotoxicity, particularly with the use of certain androgens 4
- Increased risk of blood clots and thrombosis 5
- Changes in lipid profiles, which can increase the risk of cardiovascular disease 5
- Increased risk of sleep apnea and respiratory problems 6
Contraindications and Precautions
Testosterone replacement therapy is contraindicated in certain individuals, including:
- Men who are actively seeking fertility treatment 3
- Men with known breast cancer or untreated prostate cancer 3
- Men who have had myocardial infarction or stroke within the last four months 3
- Men with severe or decompensated heart failure 3
- Men with a history of hepatotoxicity or liver disease 4
Monitoring and Follow-Up
Regular monitoring and follow-up are essential for men undergoing testosterone replacement therapy. This includes:
- Regular measurements of testosterone levels, hematocrit, and prostate-specific antigen (PSA) concentrations 3
- Assessment of bone density and quality 3
- Monitoring for adverse effects, such as changes in lipid profiles, blood clots, and respiratory problems 5
- Regular follow-up appointments with a healthcare provider to assess the effectiveness of treatment and adjust the dose as needed 6