Published July 23, 2026
In December 2025, the FDA approved an updated label for Depo-Provera CI and Depo-SubQ Provera 104, the injectable and subcutaneous forms of Pfizer's contraceptive, adding a new warning about meningioma — a tumor that grows in the tissue surrounding the brain or spinal cord. The updated label directs doctors to monitor patients for signs of meningioma and to discontinue the drug if one is diagnosed.
The label change came after a longer back-and-forth than the December approval alone suggests. According to court filings, Pfizer said it first became aware of a possible meningioma link in 2023 and asked the FDA in early 2024 to add a warning to the label. The FDA initially denied that request, saying the studies available at the time didn't clearly support a warning across all medroxyprogesterone acetate products. Pfizer revised and resubmitted its request in June 2025, and this time the agency agreed.
Much of the pressure behind the label change traces to a study published in a major medical journal in 2024, which found that women using Depo-Provera for more than a year had roughly 5.5 times the risk of developing meningioma compared with non-users. That research has been widely cited both in the FDA's reversal and in the wave of lawsuits that followed.
In litigation, Pfizer had argued it couldn't be held liable for failing to warn patients because the FDA itself had rejected an earlier request to update the label. The December 2025 reversal undercuts that defense, and is widely viewed by legal observers as one of the developments that pushed Pfizer toward the broader settlement framework it negotiated with plaintiffs' lawyers in 2026. If you used Depo-Provera and were later diagnosed with a meningioma, see Atumio's Depo-Provera case page for a free case review, or start your case review directly.