The U.S. Food and Drug Administration has required new suicide-risk information on the labels of gonadotropin-releasing hormone (GnRH) agonists, the class of drugs used as puberty blockers, according to FDA approval letters.
The FDA action
On March 10, 2026, the FDA notified manufacturers of GnRH agonist products, under section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act, of "new safety information that we have determined should be included in the labeling." The letters state that the information "pertains to the serious risks of suicidal ideation and suicidal attempt."
Section 505(o)(4) allows the FDA to require safety labeling changes when it becomes aware of new safety information.
Labels updated
FDA records show these revised labels were approved:
- Lupron (leuprolide acetate) injection, May 6, 2026. The postmarketing section now lists "Psychiatric disorders – Suicidal ideation and attempt." (approval letter, label)
- Zoladex (goserelin) implant, May 6, 2026 (approval letter)
- Vantas (histrelin acetate) implant, May 6, 2026 (approval letter)
- Trelstar (triptorelin pamoate), June 26, 2026, adding "depression, suicidal ideation and attempt" to postmarketing experience (FDA safety labeling database)
The FDA did not issue a press release or a Drug Safety Communication about the change.
Pediatric products
GnRH agonists sold for children with early puberty include Lupron Depot-Ped, Fensolvi, Triptodur and Supprelin LA. The current Lupron Depot-Ped label already warns of "psychiatric events" and lists "Depression, including rare reports of suicidal ideation and attempt" (DailyMed).
FDA emails from January 2022, obtained through a records request and published by Just the News, describe a 2016–2017 FDA review of children taking these drugs. An FDA clinical team leader wrote: "We did find increased risk of depression and suicidality, as well as increased seizure risk and we issued SLCs to the entire class for these AEs."
Use for gender dysphoria
No GnRH agonist is FDA-approved to treat gender dysphoria in minors. Use for that purpose is off-label. A November 2025 evidence review by the U.S. Department of Health and Human Services rated the overall quality of evidence for puberty blockers and cross-sex hormones in minors as very low.
*Cover image: Lupron prescribing information approved May 2026, U.S. Food and Drug Administration*