A Food and Drug Administration official recommended approving puberty blockers for youth with gender dysphoria while acknowledging that a study showed the drugs were associated with an "increased risk in depression and suicidality," according to internal emails released by America First Legal.
Sharon Sullivan, the clinical team leader at the FDA's Division of General Endocrinology, in January 2022 wrote in an email to her supervisor: "There is definitely a need for these drugs to be approved for gender transition, as they are typically not covered by insurance and are expensive out of pocket.
"We found no effect on bone (after factoring in catch-up growth), including no increase in fracture risk. We did find increased risk of depression and suicidality, as well as increased seizure risk and we issued" safety-related labeling changes, she wrote.
Puberty blockers are used off-label in minors for the treatment of gender dysphoria. This means the medications are not approved by the FDA to treat this specific diagnosis.
The study Sullivan noted was a "safety review of the GnRH agonist class in pediatric patients in 2016/2017," conducted by the agency's Division of Metabolism and Endocrinology Products.
The review "focused on suicidal ideation/depression, seizures, and bone health," Sullivan wrote in the email. Although most of the minors in the study suffered from central precocious puberty (in which puberty starts too early), "a handful were transgender kids using the drugs off-label."
America First Legal obtained the email in the discovery process of a lawsuit and made it available to The Daily Signal.
"It is shocking and unacceptable that the FDA would admit that puberty blockers cause suicidal ideation and depression, yet in the same breath recommend their approval for transgender 'medical' procedures for children," Ian Prior, senior adviser at America First Legal, told The Daily Signal.
"The advocates of these brutal practices on children claim that they are necessary to prevent suicide and depression, but in reality, the treatments themselves cause the very thing they claim they are trying to prevent," Prior added. "This barbarism has no place in a civilized society and it's time for the federal government to follow the lead of Europe in banning these experiments on children."