FDA Finally Adds Brain Tumor Warning to Depo-Provera — After Years of Legal and Scientific Pressure

Publish Date : 12/22/2025

In a major update affecting millions of women, the U.S. Food and Drug Administration (FDA) has approved a revision to the warning label for Depo-Provera, one of the most widely used long-acting contraceptive injections. The updated label now includes a warning about a possible link between the drug and meningiomas, a type of brain tumor, a risk about which many women say they were never warned.

What Changed — and Why It Matters

Until December 2025, Depo-Provera’s U.S. label did not mention any association with brain tumors, standing in stark contrast to safety labels in Canada and the European Union, where regulators have included brain tumor warnings since at least 2022.

After years of scientific research, litigation, and pressure from women and their lawyers, the FDA agreed to update the prescribing information for medroxyprogesterone acetate — the active hormone in Depo-Provera, to include language about reported cases of meningioma with repeated use. The revised label now advises healthcare providers to monitor patients for signs and symptoms of these tumors and to discontinue the shot if a meningioma is diagnosed.

This change may seem straightforward, but it represents a major shift in regulatory stance and underscores longstanding concerns about how pharmaceutical companies disclose serious safety risks to doctors and patients.

What Research Has Found

Emerging scientific evidence has tied long-term use of Depo-Provera to an increased risk of developing meningiomas, tumors forming in the membranes covering the brain and spinal cord. Some studies suggest women who used the shot for more than a year may be multiple times more likely to develop these tumors compared to non-users.

Meningiomas can be benign, but their location inside the skull can cause severe neurological problems, including:

• Persistent headaches
• Vision changes
• Seizures
• Dizziness
• Pressure symptoms in the brain

For many affected women, these symptoms first appeared without warning and, only after diagnosis, did they learn of the potential link between their condition and Depo-Provera.

Why Warnings Came Late in the U.S.

In 2024, Pfizer, the manufacturer of Depo-Provera, initially asked the FDA to update the label to reflect the brain tumor risk. That request was rejected by U.S. regulators at the time, even though similar warnings were already required in Canada and the E.U.

Critics and plaintiffs’ lawyers allege Pfizer’s initial submission was incomplete and may have been designed to delay or blunt regulatory action. They argue the company knew or should have known about the meningioma risk years earlier, and failing to include a warning deprived patients and their doctors of critical safety information.

Hundreds — and Possibly Thousands — Are Speaking Out

More than 2,000 women in the United States have filed lawsuits alleging prolonged use of Depo-Provera contributed to the development of meningioma brain tumors and Pfizer failed to warn them properly.

Many of those cases are part of coordinated litigation (including multidistrict litigation, or MDL) in federal court. Attorneys for the plaintiffs say the label change is important not just for safety, but for justice, arguing it may strengthen failure-to-warn claims by showing regulators and manufacturers are now recognizing a risk about which women were not adequately warned.

What Patients Should Know

• Depo-Provera’s label now includes a warning about a potential association with meningioma, particularly with long-term use.
• Women considering or currently using the Depo shot should talk with their doctors about the updated safety information.
• Symptoms like persistent headaches, vision problems, or neurological changes should not be ignored — especially in long-term users.
• Alternative contraceptive options exist and may be appropriate for those concerned about this risk.

Even though Depo-Provera remains approved and widely used, the new label reflects a broader and deeper understanding of potential risks and highlights the importance of full, transparent drug safety communication.

If you or a loved one used Depo-Provera and later were diagnosed with a brain tumor or neurological condition, you may want to consult a lawyer experienced in pharmaceutical failure-to-warn litigation to understand if you have a claim. The legal landscape is evolving as science and regulatory action catch up to concerns raised by patients and advocates. Dial 1-877-542-4646 or use the nearby form to reach a Depo-Provera attorney.