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Physicians File Petition With FDA To Stop Off-Label Use Of Puberty Blockers For Minors

A group of medical professionals, health care experts and parents filed a citizen petition with the Food and Drug Administration (FDA) Tuesday, asking the agency to halt the use of puberty blockers for off-label purposes such as sex change procedures.

The petition explains that medications such as Lupron Depot-PED, Supprelin LA, Fensolvi, Synarel, and Triptodur have been approved by the FDA to treat “cancers, endometriosis, and, in pediatric populations, central precocious puberty,” but in the last several years have been used for children that wish to change genders. As a result, the petitioners argue that children who take this medication to “put puberty on hold” may suffer potential risks that they were not made aware of due to a lack of FDA regulations regarding the use of these drugs for sex change procedures.

“What is most concerning is that, because puberty blockers are not FDA-approved in children with gender dysphoria, there is no demonstrated benefit of the drugs to justify these risks,” the petition reads. “This is why Sweden, Finland, the UK, Norway, and other countries have all turned against the use of puberty blockers and other medical interventions as a front-line treatment of gender dysphoria, recognizing this use as experimental.”

The petition notes that the risks of puberty blockers to children include bone health, “fertility (when followed by cross-sex hormones)” and “neurocognitive development,” just to name a few. Additionally, medical professionals point to a lack of scientific consensus around the issue and the recent “sharp criticism” of two Dutch studies that have been used to defend puberty blockers as a treatment for gender dysphoria.

“[O]ne review notes the small sample size, compounded by significant attrition so outcome measures were available for subsets of patients numbering only between 32 and 55,” the petition reads. “This review further notes that the follow-up period was too short for treatments that may entail irreversible change and lifelong medication. Another review published in 2023 characterized the studies as ‘methodologically flawed,’ concluding they ‘should have never been used in medical settings as justification to scale this ‘innovative clinical practice.’”

In conclusion, the petition requests that the agency “commission a systematic review of this off-label use by the National Academy of Sciences, Engineering, and Medicine (NASEM)” and ask for long-term studies to be conducted on this off-label use. It also asks that the FDA create a website to specifically address off-label use of these drugs for minors with gender dysphoria and “alert manufacturers and providers to the consequences of unlawful promotions of this off-label use.”

Sex changes for minors have increased at a rapid rate for the past several years, according to recent studies. One published by the JAMA Network in August found that the number of children aged 12-18 who obtained breast and chest sex-change surgeries nearly tripled from 4,552 to 13,011 between 2016 and 2019.

The FDA told the Daily Caller News Foundation that the agency “is reviewing the petition and will respond directly to the petitioner.”

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