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FDA requests updated labeling for testosterone therapies

A photo of a billboard with the picture of a smiling gray-haired man in a t-shirt smiling next to the words "Testosterone Replacement Therapy"
The move has been made after a controversial clinical trial. Photo: George Rose/Getty Images

Regulator says that warnings about the safety and effectiveness of testosterone replacement therapy should be removed from labels.

A “request” that manufacturers of testosterone replacement therapy (TRT) products update their prescribing information to reflect new clinical evidence on cardiovascular safety, prostate cancer risk, and use in age‑related hypogonadism has been made by the US Food and Drug Administration (FDA).

The agency’s action follows a multi‑year review of

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