The FDA is examining whether testosterone should be prescribed to women for menopause symptoms, a use the agency has never approved and one that has spread in practice faster than the evidence behind it.
The review, reported by ABC News, centers on a drug long associated with men. Testosterone is approved in the U.S. for low testosterone in men, but it is not cleared for treating hot flashes, mood changes, or other menopause symptoms in women. Still, some doctors prescribe it off-label, and online clinics have made it easier for women to ask for it directly.
The agency has not announced a decision, and no new approval has been granted. What is under discussion is whether the existing evidence supports a formal review of the drug for this population at all.
Medical groups have taken different positions. Some say the data on testosterone in women is too limited to justify broad use, pointing to small study sizes and short follow-up. Others argue that the demand is already substantial and that leaving it unregulated pushes patients toward unmonitored sources.
Testosterone is a controlled substance in the U.S., which adds another layer. Prescribing it off-label is legal, but it is not the same as an approval, and side effects in women can include acne, voice changes, and effects on cholesterol and liver function.
The FDA has not said when it will finish the review or whether it will lead to labeling changes. For now, the question is not whether women are using testosterone for menopause symptoms — many are — but whether the regulatory system will catch up to what is already happening in clinics and online.