For Immediate Release
December 22, 2025

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Democrats for an Informed Approach to Gender has co-signed a citizen petition to the Food and Drug Administration (FDA) asking for regulatory action to address to the harms associated with off-label use of estrogen for males as part of so-called “gender-affirming care.”

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The petition cites growing evidence that off-label use of estrogen in males significantly heightens the risk of cardiovascular events, stroke, cancer, sexual dysfunction and irreversible infertility. It is associated with a 1,000% increase in stroke risk, a 2,600% increase in testicular cancer, and decreased life expectancy.

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The petition requests that the FDA open a public docket that would serve as a repository for information about the off-label prescription of estrogen to feminize males. It further asks for a public hearing on the matter. The petitioners recommend that the FDA issue a Drug Safety Communication to prescribers and the public; label estrogen use to alter male secondary sex traits as not FDA-approved and associated with serious risks; conduct a comprehensive safety review and Risk Evaluation and Mitigations Study (REMS) into the prevalence and clinical context in which male patients receive off-label estrogen.

 

The petitioners note a significant proportion of male patients prescribed estrogen present with Autism Spectrum Disorder (ASD), trauma and psychiatric disorders that make them prone to attribute their distress to gender dysphoria. A young man may believe himself to be a transgender woman, but his body remains male. Exogenous estrogen taken by males carries serious medical risk. The FDA must exercise its oversight authority. Democrats for an Informed Approach to Gender shares the concerns of distinguished scientists about the use of this drug for which there is no reliable evidence of mental health benefit.

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​The petition has already been submitted to the FDA with more than 220 signatures. It is no longer possible to add a signature. However, if the FDA grants the the petitioner’s request and opens a public docket, any citizen may comment.

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Media contact: Martha Wexler

martha@di-ag.org

To learn more about DIAG, please visit di-ag.org.