Studies
Europe's 15-month head start on the FDA warning
European regulators concluded the depo shot's meningioma risk in September 2024. The FDA didn't add its own warning until December 2025. Here's the timeline.
Two regulators, the same drug, two different timelines
Both European and US regulators looked at the same signal: a link between high-dose medroxyprogesterone acetate, the depo shot, and meningioma, a usually non-cancerous brain tumor. European regulators finished their review and recommended a label change in September 2024. The FDA didn’t add its own warning until December 2025, about 15 months later.
This page lays out what each regulator did, and when, using each regulator’s own published record.
What did European regulators do, and when?
The European Medicines Agency’s safety committee, the PRAC, concluded there is an increased risk of meningioma in people taking high doses of medroxyprogesterone acetate at its meeting on September 2 to 5, 2024. That same committee is now also reviewing the newer Danish 12-formulation study, a separate, later referral.
The 2024 review covered injectable or tablet doses of 100mg or more, taken for several years. It recommended that product information for those medicines be updated to include meningioma as a possible side effect.
Weeks later, Pfizer’s UK operation sent doctors a formal safety notice, a Direct Healthcare Professional Communication, dated October 7, 2024. It told prescribers plainly that there is a small increased risk of developing meningioma with high doses of medroxyprogesterone acetate, and that the medicine is now contraindicated for anyone with a meningioma or a history of one.
How the record moved, EU and US
What the FDA did, and when
Pfizer first asked the FDA to add a meningioma warning to the depo shot’s US label on February 5, 2024. The FDA’s own December 2025 approval letter references a prior “November 1, 2024, action letter” it had sent in response. That earlier letter itself isn’t public, so what it said isn’t independently confirmed here. What is confirmed, in the FDA’s own words: Pfizer’s next move was a “complete response” amendment, dated June 12, 2025, answering whatever that November 2024 letter asked for.
The FDA approved the finished warning on December 12, 2025, about 15 months after European regulators reached their own conclusion.
What the current FDA warning actually says
The FDA-approved label now carries a new section, 5.4 Meningioma. Its exact language:
“Cases of meningiomas have been reported following repeated administration of medroxyprogesterone acetate, primarily with long term use. Monitor patients on Depo-Provera CI for signs and symptoms of meningioma. Discontinue Depo-Provera CI if a meningioma is diagnosed.”
That’s the FDA telling doctors to watch for it and stop the drug if it’s found. It isn’t the FDA saying the depo shot causes meningioma in any one person. A federal judge is still weighing that broader question in the consolidated lawsuit, MDL 3140, over the same studies that measured the risk in the first place.
The gap, and what it means for you
Reading the two records side by side, European regulators moved on this signal first, and by more than a year. Whether that gap changed anything for any one woman isn’t something either regulator’s record can answer. What the gap does show is that the case for a warning existed well before the FDA’s own label caught up.
If you used the depo shot and were later diagnosed with meningioma, the lawsuit doesn’t require the FDA to have acted sooner. It’s already open to you today.
Find out where you stand
You don’t need to read a regulatory filing to know if this applies to you. Two questions tell you where you stand, no name, phone, or email required yet.