FDA official recommends approval of puberty blockers despite depression risks

The Food and Drug Administration (FDA) is facing scrutiny after an internal email revealed that a team leader recommended approving puberty blockers for transgender teens, despite acknowledging increased risks of depression and suicidal thoughts associated with the drugs.

Shannon Sullivan, clinical team leader at the FDA's Division of General Endocrinology, noted in a January 2022 email that a safety review of gonadotropin-releasing hormone (GnRH) agonists in pediatric patients found "increased risk of depression and suicidality, as well as increased seizure risk." GnRH agonists are used to suppress puberty in children with gender dysphoria, the Daily Signal reports.

Despite these findings, Sullivan recommended approving the drugs for gender transition, citing a "need for these drugs to be approved" due to insurance coverage issues and high out-of-pocket costs.

The email was obtained by the conservative nonprofit America First Legal through a lawsuit and shared with media outlets. Ian Prior, senior adviser at America First Legal, called the recommendation "shocking and unacceptable," stating that the treatments "cause the very thing they claim they are trying to prevent."

The FDA has not officially approved GnRH agonists for treating gender dysphoria, although they are sometimes prescribed off-label for this purpose. The drugs are approved for central precocious puberty, a condition where puberty starts unusually early.

This revelation comes amid ongoing debate about the use of puberty blockers and other medical interventions for transgender youth. Critics argue that these treatments can have serious side effects, including potential impacts on fertility and sexual function.

The FDA has not yet publicly responded to the concerns raised by the leaked email.