FDA Issues New Brain Tumor Warning for Depo-Provera

On December 12, 2025, the U.S. Food and Drug Administration (FDA) approved a new safety warning for Depo-Provera, a widely used injectable birth control medication. The updated label now warns users about an increased risk of developing a meningioma, a type of brain tumor linked to longterm use of the drug.

This important update follows growing scientific evidence and a rising number of lawsuits filed by women who developed meningiomas after years of Depo-Provera use.

What Is a Meningioma?

A meningioma is a tumor that forms on the membranes surrounding the brain and spinal cord. While most meningiomas are considered benign, they can still cause serious and sometimes lifealtering neurological problems, including:

• Seizures
• Strokes
• Chronic migraines
• Vision or hearing changes
• Cognitive or memory issues

Many meningiomas require lifelong monitoring, and some cannot be surgically removed due to their location in the brain or spine. Even when benign, these tumors can significantly impact a person’s quality of life.

Why Did the FDA Add a Warning to Depo-Provera?

The FDA’s decision comes after multiple studies identified a strong association between prolonged Depo-Provera use and the development of meningiomas. As more women came forward with diagnoses, lawsuits began to mount, prompting closer regulatory scrutiny.

In February 2025, these lawsuits were consolidated into a multidistrict litigation (MDL) before Judge Casey M. Rodgers in the Northern District of Florida. Consolidation allows the court to efficiently manage the growing number of cases and ensures consistent rulings across similar claims.

The FDA’s new warning reflects the seriousness of the issue and the need for consumers to be fully informed about the risks associated with longterm Depo-Provera use.

Advocating for Women Harmed by Depo-Provera

Beasley Allen attorneys Roger Smith and Mary Cam Raybon are actively representing women who developed meningiomas after using Depo-Provera for a year or more. Our firm has already filed multiple cases in the MDL, with more expected as awareness grows.

We are committed to helping women understand their rights, navigate the legal process, and pursue justice for the harm they have suffered.