FDA Issues Warning on Puberty Blockers

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Earlier this month, the U.S. Food and Drug Administration (FDA) warned that the puberty blockers known as gonadotropin-releasing hormone (GnRH) agonists could lead to the development of pseudotumor cerebri, or tumor-like masses in the brain. Symptoms include—but are not limited to—severe headaches, dizziness, nausea, increased blood pressure, ringing in the ears, pain behind the eyes, blurred vision and even permanent vision loss.

The warning was prompted by six cases in which biological females ages 5 to 12 years were diagnosed with pseudotumor cerebri after taking GnRH agonist. According to the American Academy of Pediatrics, five of the girls were undergoing treatments for central precocious puberty—or early-onset puberty—and one was receiving transgender treatments.

The onset of pseudotumor cerebri symptoms ranged from three to 240 days after the girls were given GnRH agonist.

An FDA spokesperson told Formulary Watch, a monthly peer-reviewed drug management journal, that the agency considered the cases “clinically serious” and therefore decided to add a warning to all product labeling for GnRH agonist formulations.

“We’re just going to keep seeing more bad reports,” Dr. Jennifer Bauwens, Family Research Council’s director of the Center for Family Studies and a licensed clinical psychologist, told The Washington Stand. “Our bodies were not made for these drugs.”

This information from the FDA contradicts President Biden’s Assistant Secretary of Health Rachel Levine’s assertion that the U.S. should not limit youth access to “gender-affirming care.”

Levine, who is openly transgender, has claimed that “Gender affirming care is life-saving, medically necessary, age-appropriate and a critical tool for health care providers.”

But Florida Surgeon General Joseph Ladapo argues that the current administration’s efforts to promote transgender treatments for minors is not only dangerous propaganda but also an assault on valid medical research.

“The federal government’s medical establishment releasing guidance failing at the most basic level of academic rigor shows that this was never about health care,” he said in an April press release. “It was about injecting political ideology into the health of our children. Children experiencing gender dysphoria should be supported by family and seek counseling, not pushed into an irreversible decision before they reach 18.”

While Bauwens believes that the debate surrounding the use of transgender drugs is far from over, she has hope that someday major medical establishments will have no choice but to expose their part in perpetuating harmful ideology.

“Good science is on our side,” she said. “Truth is on our side. Those things always prevail when given the opportunity.”