An FDA expert suggested approving puberty blockers for young people with gender dysphoria despite risks of depression and suicide.
Shannon Sullivan, head of the FDA’s Division of General Endocrinology, told her boss in January 2022 that the FDA should approve puberty blockers for teens, even though a safety review showed they could harm mental health. The review found that these drugs increase the risks of depression and suicide.
In a leaked email, Sullivan said the FDA’s Division of Urology, Obstetrics, and Gynecology studied young people on puberty blockers. She admitted the drug has high risks of depression, suicide, and seizures.
Despite these concerns, Sullivan said puberty blockers should be approved. She noted that these drugs are often not covered by insurance and are expensive out of pocket.
Leaked emails from Rachel Levine’s office showed efforts to push global health organizations to remove age limits for minors getting gender transition surgeries. Legal and insurance factors influenced Levine’s decisions.
Using puberty blockers for young people transitioning genders has become a hot topic. There isn’t much information on how these drugs affect minors.
Since 2021, 25 states have put rules in place, often stopping transgender minors from getting puberty blockers, cross-sex hormones, or surgeries.
In the UK, the National Health Service banned puberty blockers for treating gender dysphoria due to a lack of evidence. A UK court recently upheld this ban.
The Cass Review, led by Dr. Hilary Cass, examined gender transition medicine for minors. The review found that puberty blockers might harm mental health due to brain changes. Cass noted that focusing too much on these drugs limited the study of other treatments.
The NHS banned puberty blockers after the Cass Review was published.
The harmful effects of puberty blockers aren’t new. The FDA has known since 2017.
A 2017 safety review by the FDA’s Division of Metabolism and Endocrinology Products contradicts claims by some American medical groups and Levine, who said gender-affirming care helps prevent suicide. The review shows the opposite.
A study from April by the University of Texas found that gender-affirming surgery for adults is linked to a higher risk of suicide attempts.
Members of the World Professional Association for Transgender Health shared stories about serious health issues or deaths after years of gender-affirming treatment in leaked discussions.
The FDA updated the labels for GnRH agonists after a 2017 review. They also found a new risk of intracranial hypertension in kids treated for CPP. This refers to the risk of pseudotumor cerebri. The risks were added to GnRH agonists like Lupron and Supprelin LA on July 1, 2022.
Lupron, known for its use in sex-offender castration, has severe side effects.
GnRH agonists help the pituitary gland release hormones, such as estrogen and testosterone, made in the ovaries and testes.
People use these medicines to treat cancers, endometriosis, uterine fibroids, early puberty in kids, and transgender hormone therapy. They can be given as shots, implants, or nasal sprays. Sometimes, these medicines cause side effects like hot flashes, sexual problems, and weaker bones because they lower hormone levels.
The FDA found a link between these drugs and adverse events in six cases, all girls aged 5-12, one of whom was receiving transgender care.
In August 2016, Kaiser Health News promoted GnRH agonists for treating gender dysphoria, saying they had been used safely for decades to treat early puberty. One family used Lupron for their son, who identified as a girl, and Kaiser Permanente covered it without mentioning Lupron’s use for sex offenders.
In February 2017, KHN and the Center for Investigative Reporting noted 10,000 adverse-event reports about Lupron filed with the FDA without mentioning gender-affirming care.
They reported that women who took Lupron to delay puberty or grow taller often experienced depression and anxiety. Some even had suicidal thoughts.
Women in their 20s who took Lupron years earlier developed bone-thinning, osteoporosis, cracked spines, chronic pain, degenerative disc disease, and needed total hip replacements.
The FDA said it was reviewing “nervous system and psychiatric events,” as well as fatal seizures linked to GnRH agonists like Lupron.
It’s a massive push for people to take dangerous medications, and once again, the FDA is at the center of the controversy.
