Pharmaceutical

FDA warns that testosterone replacement therapy should not be used for age-related hypogonadism

Low T1 FDA warns that testosterone replacement therapy should not be used for age related hypogonadismThe Food and Drug Administration (FDA) is warning doctors not to prescribe testosterone replacement therapy to men with age-related hypogonadism due to cardiovascular risks.

Prescription testosterone treatments are designed to treat hypogonadism, a condition in which men’s bodies do not produce enough testosterone. In younger men, this is generally due to disease or defect. Low testosterone can affect fertility and cause other problems including low libido and muscle loss.

As a man ages, testosterone levels naturally drop. Despite advertisements from manufacturers of testosterone replacement therapy promising increased sex drive and weight loss, this is not an indication for testosterone treatment, the FDA warns, and could pose health risks to men.

Studies have shown that testosterone replacement therapy can cause adverse effects. For example, one study showed that men were 30 percent more likely to suffer a heart attack, stroke or die after three years of treatment. Another study showed that heart attack and stroke risk was increased within the first 90 days of treatment.

Even more concerning is that men who began the study with clear, unobstructed coronary arteries were just as likely to have a heart attack, stroke or die as men who entered the study with established coronary artery disease.

Testosterone treatments, such as Androgel, Axiron and Testim, are available in injections, patches, gels and nasal sprays. Researchers are currently developing testosterone in oral tablets. Manufacturers of testosterone treatments are currently facing lawsuits alleging they did not adequately warn the doctors or patients of the cardiovascular risks associated with their testosterone treatments.

Source: News Watch