The Food and Drug Administration (FDA) is asking manufacturers of testosterone supplements to hold clinical trials of their testosterone replacement treatments marketed to older men to help boost low levels of the hormone.
The agency wants to know how men lured by advertising campaigns for testosterone products fared after taking the drugs, especially since data shows that a large number of those who were prescribed the treatments were never tested to determine if they actually had low levels of testosterone in their blood.
Testosterone replacement therapies are designed to boost the hormone in men who suffer from hypogonadism, a condition in which too little testosterone is produced by the testes due to defects or disease. However, drug companies have heavily promoted the drugs through advertising campaigns asking men if they suffer from symptoms of “Low T,” such as low libido, weight gain and muscle loss.
The marketing efforts resulted in skyrocketing sales of testosterone drugs such as brand-name products AndroGel, Testim and Axiron.
Testosterone naturally declines as men age, thus another concern was whether aging men would benefit from testosterone therapy or would they be more susceptible to adverse events?
Last year, a study published in the Journal of the American Medical Association revealed that older men on testosterone replacement therapy were at an increased risk of heart attack, stroke and death.
The FDA launched an investigation into testosterone side effects reports and ordered that the prescribing instructions be changed to indicate the medication was only for men with diagnosed hypogonadism. The agency also added new blood clot warnings and information about cardiovascular risks to the drugs’ safety labels. The agency is now ordering testosterone makers to conduct studies of older men using their products to help better evaluate cardiovascular outcomes.
Source: NY Times