Two new studies suggest millions of men may be risking a heart attack, stroke or premature death by using testosterone replacement therapy. Based on these studies, the FDA issued a safety announcement on January 31, 2014, saying that they are conducting an investigation and cautioning health-care professionals to carefully weigh the pros and cons of testosterone medications before writing prescriptions.
The news is surprising, and the media frenzy has added fuel to the flames of what one men’s health expert has called “hormonophobia.”
So should you or someone you care about be using testosterone replacement therapy? The short answer is maybe, if it really is low T, and after a careful assessment of total health. MedShadow took a close look at the new studies and spoke to two men’s health experts to separate the facts from the frenzy.
The testosterone replacement market
The overall market for testosterone replacement drugs was worth about $2 billion in 2012 and is projected to grow to $5 billion in 2015. The FDA-approved products include a topical gel, transdermal patch, buccal system (an adhesive, tablet-shaped patch applied to the upper gum or inner cheek) and injection delivery formats.
Available only by prescription, testosterone drugs are approved for use in men who have low testosterone (low T) and an associated medical condition, such as a failure of the testicles to produce testosterone due to chemotherapy, genetic problems, or conditions affecting the hypothalamus and pituitary gland, the brain structures responsible for controlling testosterone production by the testicles.
How many men have low T?
Testosterone levels decline with age, starting when a man is in his 30s, but the incidence of low T varies depending the source. The FDA estimates that 4 to 5 million American men have low T, also called testosterone deficiency, but that only about 5 percent are treated. One U.S. study in 2006 found a rate of 39 per cent among 2,162 men age 45 and older, classifying men as having low T if their total T level was below 300 ng/dL (nanograms per deciliter). Scaling that incidence rate up to the general population would mean that 13.8 million men might have low T. The researchers also found that for every 10-year increase in age, the risk of testosterone deficiency increased by 17 percent.
Symptoms of low testosterone
Low libido or erectile dysfunction are hallmark indications, but only some men with testosterone deficiency will have symptoms. The Endocrine Society’s Clinical Practice Guideline for Testosterone Therapy in Adult Men provides an overview of signs and symptoms:
More specific signs and symptoms of low T:
- Incomplete or delayed development of sexual characteristics
- Reduced libido and activity
- Decreased spontaneous erections, decreased ability to maintain erections
- Breast discomfort from gynecomastia (swollen breast tissue)
- Loss of axillary and pubic hair, reduced shaving
- Very small or shrinking testes
- Low sperm count
- Loss of height, low-trauma fracture, low bone mineral density
- Hot flushes, sweats
Less specific signs and symptoms of low T:
- Decreased motivation, energy and self-confidence
- Depressed mood
- Poor concentration and memory
- Sleep disturbances
- Mild anemia
- Reduced muscle mass and strength
- Increased body fat and body mass index (BMI)
- Decreased physical performance