Pharmaceutical

FDA approves new warnings on testosterone replacement therapy labels

Low T1 FDA approves new warnings on testosterone replacement therapy labels The Food and Drug Administration (FDA) has approved the updated safety labels for all prescription testosterone replacement therapies as well as anabolic androgenic steroids (AAS) to include a new subsection under the Warnings & Precautions section regarding the risk of abuse and dependence.

“Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions,” the updated label states.

Testosterone – especially at high doses and in conjunction with AAS – is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system. Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility.

People who abuse these drugs have also reported withdrawal symptoms such as depression, fatigue, irritability, loss of appetite, decreased libido and insomnia.

Testosterone treatments, such as the popular AndroGel, are intended for men with hypogonadism, a condition in which the body does not produce enough of the male hormone due to disease or defect. It is not intended for age-related hypogonadism, though manufacturers of testosterone products have promoted the drugs directly to consumers for so-called Low T.

Makers of testosterone products face thousands of lawsuits alleging the companies did not warn consumers that use of the drugs could cause men to suffer heart attacks, strokes and blood clots. The first eight bellwether trials are scheduled for 2017.

Sources:
FDA
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