The growing misuse of testosterone hit the news in June 2013. It would be fair to say that the reports probably ignited curiosity as much as they did caution: “It is touted as the fountain of youth: the hormone testosterone, which some men say helps them build muscle, lose weight and gain energy.
At the Anzac Research Institute, Dr David Handelsman had found that testosterone prescribing increased in all Australian states and territories from 1992 until 2010. Statistics from the pharmaceutical benefits scheme showed that the number of men using long-acting testosterone injections had almost doubled.
"It's wasteful, it's misguided, it's not rational prescribing. The risks are accelerating cardiovascular disease and accelerating prostate disease. The risks are not facts yet but they are very good reasons to be cautious," he warned.
In 2013, 2.3 million Americans were being treated with testosterone therapy. By 2014, testosterone use had quadrupled in the US since the early 2000s for men in their 40s, This was blamed in part on a marketing drive that suggested the drugs are a solution for low energy, low libido and other ills, many of them associated with ageing.
In January 2014, the FDA announced formally that it would investigate the risk of stroke, heart attack and death in men taking testosterone products after reports of elevated cardiovascular risk associated with testosterone therapy. While testosterone replacement was known to be an important therapy for men with established androgen deficiency, prescriptions for testosterone increasing at levels that suggested, “use of testosterone is expanding beyond the evidence-based indications”.
This is what the study aimed to determine:
- Testosterone therapy is linked to increased risk of cardiovascular events
Two observational studies had concluded that the risk of adverse cardiovascular events was greatest in men with a history of cardiovascular disease and men aged over 65 years. - Testosterone therapy is only indicated in men with proven androgen deficiency
There is little evidence supporting testosterone therapy as a treatment for normal age-related decline in testosterone levels. - Follow guidelines for identifying, diagnosing and managing men with androgen deficiency
Investigate clinical symptoms of androgen deficiency using hormone assays; treat with androgen replacement therapy when indicated. Refer to a clinical endocrinologist when the diagnosis is unclear. - Testosterone deficiency is an unlikely cause of erectile dysfunction
However, men presenting with erectile dysfunction should be investigated for deficiency.
On March 3 2015, The Food and Drug Administration made its determination.
Manufacturers of testosterone drugs will be required to change labels for the drugs to warn that they could increase the risk of heart attacks and strokes and should not be prescribed to treat symptoms in men brought on by age, such as declining sexual drive.
The precise wording of the new labelling is being worked out and as yet, there is no fixed date for when it will come into effect.
The FDA has approved testosterone therapy for medical conditions including disorders in which the testicles do not produce testosterone because of genetic problems, or for damage from chemotherapy or infection. The drugs are not approved for conditions related to ageing or declining sexual drive.
“We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications,” the FDA said in a statement.
