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GOP Sens. Marsha Blackburn of Tennessee and Cynthia Lummis of Wyoming wrote a letter to FDA Commissioner Robert Califf on Thursday about the side-effects of gonadotropin-releasing hormone (GnRH) agonists, which are used to treat minors with early-onset puberty, as well as stave off the normal pubescent development of minors who may be considering sex-reassignment surgery.
The FDA added a warning to the use of GnRH agonists in July over reported cases of pseudotumor cerebri, a condition that mimics the symptoms of a brain tumor but has no obvious source. GnRH agonists are found in drugs such as Lupron Depot-Ped, Fensolvi, Synarel, Supprelin LA, and Triptodur.
The senators noted that while GnRH agonists are approved for use by patients with developmental disorders such as central precocious puberty (CPP), which makes a child experience puberty younger than normal, the drug is not approved for gender dysphoric or transgender treatment. According to a study published in the National Library of Medicine, GnRH is recommended for initial treatments of minors struggling with gender dysphoria.
“[T]he off-label use of GnRH agonists in connection with diagnoses of gender dysphoria or the provision of transgender care is, by definition, intended to suppress the normal biological processes of puberty beyond the normal age of onset. Given that such off-label use deliberately delays and alters normal development, We are deeply concerned that it could result in significant short-term and long-term risks and adverse effects on adolescent patients,” the senators wrote.
“Our concern has been heightened by reports of increased off-label use of GnRH agonists in connection with transgender care,” they added. They then requested trial studies, cases of negative side-effects, and other information on use of GnRH agonists.
Blackburn and Lummis’ letter comes days after Daily Wire host Matt Walsh posted shocking videos of a doctor at a Transgender Clinic at Vanderbilt University Medical promoting transgender surgeries as a “big money maker.” The doctor who made the comments works with adult patients.
The medical center has also detailed transgender surgeries and treatments available for minors. Video from the Vanderbilt Psychiatry YouTube channel reveals the medical center “explicitly [admits] that they will give and have given irreversible hormone drugs to children as young as 13,” Walsh wrote.
The university released a statement after Walsh’s report claiming that reports of its transgender care “misrepresented facts.”
“We have been and will continue to be committed to providing family-centered care to all adolescents in compliance with state law and in line with professional practice standards and guidance established by medical specialty societies,” the statement said.
Blackburn has joined other Tennessee officials in calling for an investigation into Vanderbilt University Medical in the wake of Walsh’s reporting.
“Using children for profit and political gain is deeply disturbing. Experts agree that there have not been enough clinical trials conducted to prove the safety and effectiveness of using these drugs on kids,” Blackburn said in a statement. “These drugs have not been approved for treating children experiencing gender dysphoria, but the left insists on experimenting on these children anyway.”
Zach Jewell contributed to this report.