The agency said that it determined putting the warning on the drugs’ labels was warranted after finding that they caused abnormally elevated spinal fluid pressure on the brain.

By Joseph Summers
Article Source

The U.S. Food and Drug Administration (FDA) is putting a warning label on several puberty blockers after a report released early this month found that the drugs cause serious side effects in children.

According to the FDA report, puberty blockers, or gonadotropin-releasing hormone (GnRH) substances, lead to a condition called pseudotumor cerebri, or elevated spinal fluid pressure on the brain, with symptoms similar to a brain tumor. The report showed that six girls between the ages of five and twelve experienced brain swelling, loss of vision, headaches, blood pressure increase, dizziness, and other symptoms of a brain tumor.

A spokesman from the FDA, speaking to Formula Watch, stated that the warning was issued because the agency determined that the symptoms were clinically severe.

“The agency considered the cases clinically serious and, based on these reviews, determined that pseudotumor cerebri … should be added as a warning and precaution in product labeling for all GnRH agonist formulations approved for use in pediatric patients,” the spokesperson said.

“Although the mechanism by which GnRH agonists may lead to development of pseudotumor cerebri has not been elucidated, and patients with [central precocious puberty (CPP), or early onset puberty] 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,” he added.

The spokesperson told Formula Watch that the agency conducted an independent review of scientific literature dealing with the drugs after AbbVie, the company that markets Lupron, identified several publications that found pseudotumor cerebri in children with CPP taking the drug.

The Biden administration has supported the use of puberty blockers in children. Assistant Secretary of Health Richard “Rachel” Levine, a man who thinks he is a woman, defended giving children puberty blockers earlier this month in an interview on MSNBC.

When asked for an opinion on states barring gender confused men from women’s sports, Levine said “we really want to base our treatment and affirm and to support and empower these youth, not to limit their participation activities in sports and even limit their ability to get gender-affirmation treatment in their state.”

Levine also tweeted this month that giving puberty blockers to children is “medically necessary.” Levine’s position was attacked by Florida Republican Gov. Ron DeSantis, who stated that “gender affirming care” is a euphemism for sterilization and castration.

About 100 percent of boys and 90 percent of girls with gender dysphoria come to accept their biological sex as they reach adulthood, according to the American Psychiatric Association, but virtually all of those started on puberty blockers later take cross-sex hormones, as LifeSiteNews has reported. These drugs sterilize users and typically lead to devastating transgender surgeries.

Puberty-blocking drugs, like Supprelin LA and Lupron, are linked to serious, permanent side effects, such as osteoporosis, cognitive impairment, and sterility. Republican have recently proposed several bills to protect children from irreversible gender transition operations and drugs.