A group of concerned medical professionals, health care experts, and parents has launched a Citizen Petition to the FDA urging action to address the alarming increase in off-label use of powerful puberty-blocking drugs for minors experiencing gender dysphoria. This class of drugs called GnRH agonists has never been approved by the FDA to treat gender dysphoria and directly harms bone and brain development and sexual functioning.  Adverse reports of use by minors also have cited vision loss and brain swelling, but the FDA has failed to take any action.      

The Citizen Petition requests the FDA take immediate steps to hold the medical industry accountable and inform the public. It asks for a systematic review of off-label use, long-term registry studies, a dedicated webpage about off-label use, and a crackdown on unlawful promotion. The FDA is required to respond to this petition within 90 days.  

Please send a comment supporting this petition before December 1 urging the FDA to undertake all actions requested and to do all in its power to take immediate action to protect vulnerable children expressing gender dysphoria from medical harm.   

Thank you!