FDA warns puberty blocker may cause brain swelling, vision loss in children

WASHINGTON (TND) — Earlier this month, the U.S. Food and Drug Administration added a warning to gonadotropin-releasing hormone (GnRH) agonists, commonly known as “puberty blockers,” indicating there were serious risks for youth who take them.

The U.S. Food and Drug Administration (FDA) identified six cases in females between the ages of 5 and 12, who were taking GnRH agonists, which presented “a plausible association between GnRH agonist use and pseudotumor cerebri.”

Pseudotumor cerebri, also known as idiopathic intracranial hypertension, occurs when the pressure inside your skull spontaneously increases, which can cause brain swelling, severe headaches, nausea, double vision, and even permanent vision loss, according to the Mayo Clinic.

Five of the six cases which exhibited links between GnRH agonist use and pseudotumor cerebri included patients who were undergoing treatment for central precocious puberty, a condition where the body matures far sooner than expected. One of the cases identified by the FDA involved a patient taking GnRH for transgender care.

“The agency considered the cases clinically serious and, based on these reviews, determined that pseudotumor cerebri (idiopathic intracranial hypertension) should be added as a warning and precaution in product labeling for all GnRH agonist formulations approved for use in pediatric patients,” an FDA spokesperson told Formulary Watch. “Although the mechanism by which GnRH agonists may lead to development of pseudotumor cerebri has not been elucidated, and patients with CPP may have a higher baseline risk of developing pseudotumor cerebri compared with children without CPP, this potential serious risk associated with GnRH agonists justifies inclusion in product labeling.”

The warning seems to conflict with U.S. Assistant Secretary of Health Rachel Levine’s claim that “there is no argument among medical professionals” that youth access to “gender-affirming care,” such as puberty blockers, is valuable and important.

READ MORE: “‘There is no argument’: Rachel Levine praises ‘gender-affirming care’ for adolescents”

Levine’s critics have charged her with conflating “opponents of LGBTQ equality” with those seeking to limit minors from accessing certain potentially life-altering gender transition therapies.

“Opponents of LGBTQ equality have targeted trans and queer youth to score political points, all to distract from the fact that they do not have any solutions to the problems that we face today,” said Levine, speaking in her own personal capacity, according to Fox News. “They have stooped so low as to try to punish parents criminally for seeking gender-affirming care for their children who need it,” Levine added. “Every major medical association agrees: gender-affirming care is life-saving, medically necessary, age-appropriate and a critical tool for health care providers.”

Florida Department of Health spokesman Jeremy Redfern, whose agency updated its guidelines earlier this year to restrict minors from obtaining gender transition therapies, told Fox News Levine’s claim that “every major medical association” agrees offering so-called “gender-affirming care” saves kid’s lives “isn’t data.”

“It’s an appeal to authority that is in stark contrast to the best available evidence,” Redfern insisted to Fox News. “The [Florida] Department of Health is following the evidence. The federal government is following the eminence.”