Sen. Marsha Blackburn (R-Tenn.) is asking the FDA to provide information about the controversial use of certain puberty blockers in children who suffer from gender dysphoria and wish to resemble the opposite sex. Blackburn says she was motivated to write the letter after viewing a recent Twitter video highlighting the profit margins made by doctors who perform treatments and surgeries for such patients.
The Food and Drug Administration’s (FDA) recent decision to add a warning regarding incidents of pseudotumor cerebri to the labeling of gonadotropin-releasing hormone (GnRH) agonists approved for the treatment of central precocious puberty (CPP)
- The FDA stated that its decision was based on six instances involving female patients between the ages of 5 and 12, of which "five were undergoing treatment for CPP and one for transgender care."
- While CPP is an approved indication for GnRH agonists, their use in connection with diagnoses of gender dysphoria or the provision of transgender care are not.
Clinical trials or other studies
- What clinical trials have been conducted to evaluate the safety and long-term effects of administering GnRH agonists in connection with diagnoses of gender dysphoria or the provision of transgender care?
- How many reports of adverse effects have the FDA received? Will the FDA commit to conducting pharmacoepidemiologic studies using electronic health data to assess the long term effects on pediatric patients?
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