• Posted December 18, 2025

FDA Adds Brain Tumor Warning to Depo-Provera Birth Control Shot

THURSDAY, Dec. 18, 2025 (HealthDay News — The U.S. Food and Drug Administration (FDA) approved a new safety warning for Depo-Provera, a widely used birth control shot made by Pfizer, alerting patients to a possible risk for a type of brain tumor called meningioma.

The agency signed off last week on a label update for two versions of the Depo-Provera injection, requiring new language about the tumor risk. 

The decision comes as Pfizer faces lawsuits from more than 1,000 women who say the company knew about the risks and didn’t warn them.

Depo-Provera is a hormone-based birth control shot given once every three months. It contains progestin, a synthetic version of the hormone progesterone. 

About 1 in 4 sexually active women in the United States has used the shot at some point, according to the U.S. Centers for Disease Control and Prevention (CDC). Use is especially common among Black women, who receive it at nearly twice the national rate.

Meningiomas are usually not cancerous, but, depending on their size and location, they can cause serious health problems.

Each year, about 39,000 meningiomas are diagnosed in the U.S., data shows.

In court filings, Pfizer said it first became aware of a possible link between Depo-Provera and meningioma in 2023. The company asked the FDA in early 2024 to add a warning to the drug’s label. 

That request was initially denied, with the FDA saying existing studies did not clearly support a warning for all products containing medroxyprogesterone acetate (MPA), the drug used in the shot.

Pfizer later revised its request and resubmitted it in June 2025. This time, the FDA agreed.

In a letter approving the change, the agency said the update “provides for the addition of information related to meningioma risk” on the labels for Depo-Provera CI and Depo-Subq Provera 104.

In a statement, Pfizer said the “label update reflects a recent decision by the FDA to approve the warning, which the agency had earlier denied.”

The statement also said: “Pfizer stands behind the safety and efficacy of Depo-Provera, which has been used by millions of women worldwide and remains an important treatment option for women seeking to manage their reproductive health.”

Attorneys representing women suing Pfizer welcomed the move, saying the new warning will help patients make better-informed choices.

Regulators in other countries had already acted. In 2024, European and Canadian health agencies added meningioma warnings to high-dose hormone products like Depo-Provera. 

South Africa followed with similar guidance earlier this year.

A U.S. judge has not yet ruled on whether the lawsuit against Pfizer will move forward.

More information 

The Mayo Clinic has more on meningioma.

SOURCE: NBC News, Dec. 16, 2025