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The FDA-approved 2026 Lupron label, with the line \"Psychiatric disorders – Suicidal ideation and attempt\" marked in red

18 October 2026

FDA orders suicide-risk labeling on the drug class used as puberty blockers

On March 10, 2026, the FDA ordered makers of GnRH agonists, the drug class doctors use as puberty blockers, to add \"the serious risks of suicidal ideation and suicidal attempt\" to their labels. The new wording went onto Lupron, Zoladex, Vantas and Trelstar between May and June. There was no press release.

The FDA has put suicide risk in writing on the drugs used to block puberty in children. It did this quietly, with no press release.

What the FDA did

On March 10, 2026, the FDA sent a letter to the makers of every GnRH agonist, the class of drugs used as puberty blockers. The letter used the agency's power under section 505(o)(4) of the federal drug law, which lets the FDA require a label change when it finds new safety information.

The FDA's own words: the new information "pertains to the serious risks of suicidal ideation and suicidal attempt."

The drug makers then filed the new labels, and the FDA approved them:

  • Lupron (leuprolide) injection was approved on May 6, 2026 (FDA approval letter). The label now reads: "Psychiatric disorders – Suicidal ideation and attempt" (label).
  • Zoladex (goserelin) was approved on May 6, 2026 (FDA approval letter).
  • Vantas (histrelin) implant was approved on May 6, 2026 (FDA approval letter).
  • Trelstar (triptorelin) was approved on June 26, 2026, adding "depression, suicidal ideation and attempt" (FDA safety labeling database).

Three of these drugs, leuprolide, triptorelin and histrelin, are the same molecules sold for children as Lupron Depot-Ped, Fensolvi, Triptodur and Supprelin LA.

The FDA has known for years

This is not new information to the FDA. It is new to the labels of the adult versions of these drugs.

The children's label for Lupron Depot-Ped already warns of "psychiatric events" and lists "Depression, including rare reports of suicidal ideation and attempt" (DailyMed).

Internal FDA emails from January 2022, released through a records request and published by Just the News, show an FDA team leader describing the agency's 2016–2017 review of children on these drugs:

> "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."

The same email notes that "a handful" of the children in that review were taking the drugs off-label for gender transition, and that no company had ever asked the FDA to approve them for that use.

Never approved for this

No GnRH agonist is FDA-approved to treat gender dysphoria. Doctors who give them to children for that reason are using them off-label.

The federal government's own evidence review in November 2025 found the evidence for puberty blockers and cross-sex hormones in children "very low" in quality. The risks are not in doubt: infertility, bone loss, and now suicide risk, written on the label by the FDA itself.

The bottom line

Parents are often told that blockers prevent suicide. The FDA has now required the labels of these drugs to list suicidal thoughts and suicide attempts as serious risks. Parents deserve to read that before anyone writes a prescription.

Cover image: Lupron prescribing information approved May 2026, U.S. Food and Drug Administration

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