FDA Alerts Testosterone Supplements May Lack Safety and Effectiveness

The Food and Drug Administration (FDA) is requiring additional clinical trials on testosterone supplements after revealing that labeling claims about their safety and efficacy are not backed by substantial evidence.

Cardiovascular risks and other health concerns have been linked to use of the drugs that are used to treat age-related low testosterone, or “age-related hypogonadism.” The testosterone supplement manufacturers will be required to conduct clinical trials to verify their safety, the FDA explained in a statement.

Although the FDA approved the testosterone supplements to treat “Low-T” and the therapy is advertised as being beneficial, a report published in the New England Journal of Medicine announced that the supporting evidence are “limited and inconclusive” and “are not supported by substantial evidence for controlled trials.”

The supplements are marketed to middle-aged and elderly men to address other conditions such as Klinefelter’s syndrome, pituitary injury, and testicular damage. However, the claims regarding their benefits are lacking proof and their overall safety is being called into question.

The journal article noted, “to date, there is no definitive evidence that increasing serum testosterone concentrations in these men is beneficial and safe.”

In March 2015, the FDA required testosterone labels be updated to include the increased risks of heart attack and stroke.

This news comes less than two days after the FDA approved the first drug for female sexual dysfunction.