There is growing concern about a condition called Low-T or low testosterone. Most males’ testosterone levels decrease with age, but levels may decrease dramatically enough to be considered an illness for some males. However, there are also concerns about the safety of some of the drugs prescribed to combat declining testosterone levels.

Low Testosterone

Androgens, hormones associated with male characteristics, decline with age. Sometimes, this can lead to low testosterone or “low T,” a condition in which the patient is not producing enough androgens (testosterone is a type of androgen, and often used as shorthand for other androgens). This can produce a suite of symptoms including fatigue, weakness, and decreased sex drive. The syndrome is sometimes called “male menopause.” It can be treated, but there is evidence that the syndrome is over-diagnosed and that the treatment may have risks.

Health Concerns

Testosterone and other androgens can have wide-ranging effects on a person’s biology. Excessive levels of testosterone have been associated with mood swings, changes in body hair, and even cancer. In fact, most of the effects of “‘roid rage,” stem from excessive testosterone, including violent, aggressive outbursts. Additionally, a 2013 study published in the Journal of the American Medical Association (JAMA) looked at the effects of testosterone supplements designed to combat low T. TheJAMA study found that patients taking testosterone supplements were more likely to suffer from blood clot-related illness. Other hormone-based drugs, such as birth control pills, have been linked to similar illnesses in women. Blood clots can cause serious medical emergencies, including strokes, pulmonary embolisms, and heart attacks. For example, the JAMA study found that patients taking androgen-replacement drugs had twice the risk of heart attacks.

Over-Promotion?

The litigation against the manufacturers of androgen-replacement drugs alleges that not only are the drugs dangerous, but that the manufacturers have aggressively promoted the drugs in spite of the risks. And a recent study found that roughly a quarter of men who received androgen-replacement drugs never had their testosterone levels tested. Drug companies who sell low-T drugs, such as AndroGel and Testim, conducted direct-to-consumer marketing, and started a “diseases awareness” campaign among physicians and patients to encourage older males to explore the possibility of low-T drugs with their physicians. Prescriptions for more than 5 million doses of androgen therapy drugs were written in the U.S. during 2013. It is estimated that by 2017, drugs for low-T will generate $5 billion a year in sales.

Legal Action

Lawsuits have been filed by “low-T” patients and their survivors. These lawsuits accuse the manufacturers of products including AndroGel and Testim of creating a dangerous drug, which can cause heart attack, stroke, and other serious blood-clot related illness. The lawsuits further allege that in spite of these risks, drug companies aggressively marketed the drugs, convincing patients and physicians to prescribe them even when there was no evidence that they were needed.