The U.S. Food and Drug Administration (FDA) has added a new safety warning to Depo-Provera, a widely used birth control shot made by Pfizer, alerting patients to a potential risk of a brain tumor called meningioma.
The FDA approved updated labels for two versions of the Depo-Provera injection last week, requiring information about the tumor risk. The move comes as Pfizer faces lawsuits from more than 1,000 women who say the company was aware of the risk but did not warn users.
Depo-Provera is a hormone-based birth control shot administered once every three months. It contains progestin, a synthetic form of the hormone progesterone. According to the U.S. Centers for Disease Control and Prevention (CDC), about one in four sexually active women in the United States has used the shot at some point, with usage particularly high among Black women, who receive it at nearly twice the national rate.
Meningiomas are usually noncancerous, but depending on their size and location, they can cause serious health problems. About 39,000 meningiomas are diagnosed in the U.S. each year.
Court documents show that Pfizer first became aware of a possible link between Depo-Provera and meningiomas in 2023 and requested an FDA label update in early 2024. The FDA initially denied the request, saying the evidence did not clearly support a warning for all products containing medroxyprogesterone acetate (MPA), the active ingredient in the shot. Pfizer revised and resubmitted the request in June 2025, and this time, the FDA approved it.
The FDA said the label update “provides for the addition of information related to meningioma risk” on Depo-Provera CI and Depo-Subq Provera 104.
Pfizer issued a statement saying the label update “reflects a recent decision by the FDA to approve the warning, which the agency had earlier denied.” The company emphasized that it “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 change, saying the new warning will allow patients to make better-informed decisions.
Health regulators in Europe, Canada, and South Africa had already added similar warnings to high-dose hormone products like Depo-Provera in recent years.
A U.S. judge has not yet ruled on whether the lawsuit against Pfizer will proceed.
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