In December 2025, the U.S. Food and Drug Administration (FDA) approved a label change to Pfizer’s widely used birth control injection Depo‑Provera. The update warns people of an increased risk of meningioma (a tumor that develops in the lining of the brain or spinal cord) connected with Depo-Provera use.
What is Depo-Provera?
Thousands of women in the United States (and across the world) use Depo-Provera as their primary birth control option, oftentimes due to its relative convenience of use. Depo-Provera is a shot given once every three months, making it a comparatively convenient birth control option.
The shot contains progestin, which is a synthetic version of the hormone progesterone. One study examining the possible link between progesterone and meningioma has reported that women who used the medication for over one year were 5.5 times more likely to develop meningiomas as compared to people who don’t use the medication.
What is Meningioma?
A meningioma is a tumor that forms on the membranes covering the brain and spinal cord. Unfortunately, it’s one of the most common brain tumors. Each year, approximately 39,000 people are diagnosed with meningioma in the United States. Symptoms of a meningioma can include headaches, vision changes, dizziness, personality changes, and seizures.
Pending Lawsuit Against Pfizer
The change to the Depo-Provera label comes while there are currently over 1,000 women in the United States who are suing Pfizer for allegedly failing to warn them about the risk of developing meningioma due to Depo-Provera use. Pfizer claims it only became aware in 2023 of the risk of meningioma connected with Depo-Provera.
Contrary to the manufacturer’s claims, lawyers for the plaintiffs in the lawsuit claim that Pfizer misled doctors, patients, and even the FDA about the alleged link between Depo-Provera and meningioma, and that thousands of women developed brain tumors as a result of using the medication. They claim that Pfizer has known about a link between Depo-Provera and meningioma for decades but failed to provide any warning about the link to Depo-Provera users.
The Label Change
In early 2024, after Pfizer claims to have learned of a meningioma risk, it applied to the FDA to add a warning to Depo-Provera’s label regarding the potential meningioma risk. The FDA initially rejected that label change request. The FDA stated at the time that the available studies didn’t support adding a meningioma risk warning to the Depo-Provera label. Despite the FDA’s initial reluctance to approve the label change, other countries, including Canada and the European Union, have required meningioma warnings on Depo-Provera labels for the last few years.
But things apparently changed at the FDA since Pfizer first requested the updated label information. Pfizer submitted another request to the FDA in June 2025 regarding a label change warning for Depo-Provera. And in December 2025 the FDA approved the label change for two versions of the injection: Depo Provera CI and Depo-Subq Provera 104.
The new warning label approved by the FDA states that meningioma cases have been reported following repeated use of Depo-Provera, primarily with long term use. The new label advises health care providers to counsel women with a history of meningioma about the possible risk of worsening meningioma with Depo-Provera use. The label further advises that medical providers should monitor Depo-Provera users for signs and symptoms of meningioma, and that Depo-Provera use should be discontinued if meningioma is diagnosed.
The label change is a significant expansion of prior label warnings regarding Depo-Provera use, which previously focused on things such as bone mineral density loss rather than meningioma risk.
Call Our Office for a Free Consultation
If you’ve been using Depo-Provera and have recently been diagnosed with a meningioma, call our office today at (954) 833-1440 for a free consultation.