FDA Warns: Depo-Provera Linked to Meningioma Brain Tumors

In December 2025, the U.S. Food and Drug Administration took a significant step by adding a new warning to the prescribing label for Depo-Provera and Depo-SubQ Provera 104, the widely used injectable contraceptives manufactured by Pfizer. The updated label now explicitly warns that use of depot medroxyprogesterone acetate (DMPA) has been associated with an increased risk of meningioma — a type of brain tumor that, while typically classified as benign, can cause serious and life-altering symptoms.

This label change came after years of mounting scientific evidence and growing pressure from patient advocacy groups. For the millions of women who have used Depo-Provera, the FDA’s acknowledgment raises urgent questions about health risks, medical monitoring, and legal rights.

What Is a Meningioma?

A meningioma is a tumor that forms in the meninges, the protective membranes that surround the brain and spinal cord. Although most meningiomas are classified as non-cancerous, that label can be misleading. These tumors can grow large enough to compress brain tissue, causing debilitating symptoms including:

• Chronic, worsening headaches
• Vision changes or partial vision loss
• Hearing loss or ringing in the ears
• Seizures
• Cognitive difficulties, including memory loss and confusion
• Weakness or numbness in the limbs
• Balance and coordination problems

Treatment for meningiomas often involves surgery, radiation therapy, or both. Even when surgery is successful, patients may face long recovery periods and lasting neurological effects. In some cases, meningiomas recur after removal.

The Connection Between Depo-Provera and Meningioma

The link between progestins and meningiomas has been studied for over a decade, but the evidence has accelerated in recent years. Meningiomas have hormone receptors — particularly progesterone receptors — which means hormonal drugs can directly influence their growth.

Multiple peer-reviewed studies have found that long-term use of high-dose progestins, including DMPA (the active ingredient in Depo-Provera), is associated with a significantly elevated risk of developing meningiomas. A landmark French study published in the British Medical Journal found that prolonged use of injectable progestins was associated with a substantially increased risk of intracranial meningioma.

The FDA’s December 2025 label update reflects the agency’s conclusion that the evidence is strong enough to warrant a formal warning. This is particularly significant because Depo-Provera has been on the market since 1992 and has been administered to millions of women worldwide.

The Growing Litigation

As of early 2026, more than 3,000 lawsuits have been filed against Pfizer by women who developed meningiomas after using Depo-Provera. These cases allege that Pfizer knew or should have known about the meningioma risk and failed to adequately warn patients and their healthcare providers.

The litigation is gaining momentum. Cases are being coordinated in courts across the country, and plaintiffs’ attorneys are working to establish the scientific and legal foundation for these claims. The FDA’s label change has strengthened the position of claimants by providing an official acknowledgment of the risk that Pfizer’s prior labeling omitted.

For a deeper overview of this litigation, learn more about Depo-Provera claims on our dedicated page.

Who May Qualify for a Claim

You may be eligible to pursue a Depo-Provera meningioma claim if:

• You received one or more Depo-Provera or Depo-SubQ Provera 104 injections
• You were subsequently diagnosed with a meningioma (intracranial)
• You have medical records supporting both the Depo-Provera use and the meningioma diagnosis
• You are not currently represented by another attorney in this matter

Even if your meningioma was treated and you have since recovered, you may still have a viable claim. The injuries associated with meningioma — including surgery, recovery time, cognitive effects, and emotional distress — can form the basis of significant legal damages.

What You Should Do Now

If you used Depo-Provera and have been diagnosed with a meningioma, or if you are experiencing symptoms such as persistent headaches, vision changes, or cognitive difficulties, consider the following steps:

1. Consult your doctor. Discuss your Depo-Provera history with your healthcare provider. If you have not been screened for meningioma, ask whether imaging is appropriate given your usage history.

2. Gather your medical records. Collect documentation of your Depo-Provera injections and any meningioma diagnosis, treatment, or monitoring. Pharmacy records, insurance claims, and medical charts are all valuable.

3. Speak with an attorney. An attorney experienced in pharmaceutical litigation can evaluate your case, explain the claims process, and help you understand your legal options without any upfront cost.

Attorney Analysis

The FDA’s label change in December 2025 was a pivotal moment in this litigation. When a federal agency formally acknowledges a risk that a manufacturer failed to disclose for decades, it fundamentally alters the legal landscape. From our perspective, the strongest cases involve women who used Depo-Provera for extended periods — multiple injections over a year or more — and who subsequently received a confirmed meningioma diagnosis. The cases we are reviewing show a clear pattern: women who were never warned about this risk, who trusted that a widely prescribed contraceptive was safe, and who are now dealing with the consequences of a brain tumor. If you fall into this category, the time to act is now. Statutes of limitations apply, and early engagement with the legal process ensures your claim is preserved and properly documented.

Take the Next Step

The Depo-Provera meningioma litigation represents one of the most significant pharmaceutical liability cases in recent years. If you or a loved one received Depo-Provera injections and were later diagnosed with a meningioma, you deserve answers — and you may deserve compensation.

If you’ve been affected, request a free case review today.