FOR IMMEDIATE RELEASE
December 18, 2025

Center for Bioethics and Culture Supports Citizen Petition Urging FDA Oversight of Off-Label Estrogen Use in Males in Gender Medicine

San Francisco, CA — The Center for Bioethics and Culture (CBC) announces its support for and participation in a citizen petition submitted to the U.S. Food and Drug Administration calling for regulatory action on the widespread off-label prescription of estrogen to males in gender medicine.

The citizen petition asks the FDA to (i) open a formal docket on this practice and (ii) convene public hearings to examine the risks, benefits, and significant scientific uncertainties associated with prescribing estrogen off-label to men and boys. To better protect patients, the petition recommends that the FDA consider requiring a boxed warning on estrogen, conducting a comprehensive safety review and Risk Evaluation and Mitigation Strategy (REMS) evaluation, mandating enhanced adverse-event reporting, and issuing clear communications to medical providers regarding appropriate safeguards.

The petition highlights a growing body of evidence documenting serious and life-altering harms associated with long-term estrogen use in males. Among the risks cited are a five-fold increase in venous thromboembolism, a ten-fold increase in stroke risk, a twenty-six-fold increase in testicular cancer, a twenty-two- to forty-fold increase in male breast cancer risk, and an approximately 80 percent increase in the standardized all-cause mortality ratio. The petition also notes evidence of decreased brain volume and increased suicidality, including higher rates of suicide attempts, planning, and hospitalization. At the same time, it emphasizes the lack of high-quality evidence demonstrating that cross-sex hormones improve mental health outcomes or reduce suicide risk.

The Center for Bioethics and Culture is deeply concerned about this issue because it sits at the intersection of medical ethics, patient safety, and informed consent. CBC’s work has long focused on examining how emerging and controversial biomedical practices affect human dignity, vulnerable populations, and the integrity of medicine itself. The widespread off-label use of estrogen in males—particularly in adolescents and young adults—raises serious ethical questions about whether patients are being adequately informed of risks, whether clinical practices are being driven by evidence or ideology, and whether normal regulatory safeguards are being bypassed.

“This petition raises profound ethical and medical concerns about a practice that has expanded rapidly without the level of scrutiny we would expect for any other drug used in this way,” said a representative of the Center for Bioethics and Culture. CBC’s involvement began when a concerned parent reached out, fearing that families were being asked to give “informed consent” without adequate information about the magnitude and uncertainty of the risks involved. “Informed consent is not possible when patients and families are not fully apprised of the magnitude and uncertainty of these risks. The FDA has a responsibility to examine this evidence openly and transparently.”

Support for the petition reflects its breadth and seriousness. It has been endorsed by 15 organizations representing a politically diverse coalition of advocacy and clinical groups, as well as more than 220 individuals. These include over 60 health-care professionals, five men who are former patients of gender medicine, and many concerned citizens calling for greater regulatory accountability.

“For too long, off-label estrogen use in males has been treated as exempt from the standards applied to other medical interventions,” the statement continued. “Ethical medicine requires rigorous evidence, honest risk disclosure, and appropriate regulatory oversight—especially when vulnerable populations are involved.”

Media Contact:
Center for Bioethics and Culture
Kallie.fell@cbc-network.org
www.cbc-network.org

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