FDA approves label change for Depo-Provera, adding brain tumor warning

The Food and Drug Administration on Friday approved a label change for Pfizer’s Depo-Provera contraceptive vaccine, which warns patients of the risk of meningioma, a tumor located in the lining of the brain.

Pfizer is currently battling a lawsuit in which more than 1,000 women claim the company knew about the risk and failed to warn patients.

The Depo-Provera regimen consists of a progestin injection given every three months. The lawsuit references several studies dating back to 1983 showing a link between progesterone and meningioma, saying those studies created a “non-assignable duty to investigate” and that Pfizer should have studied the risks associated with Depo-Provera sooner. (Progestin is a synthetic version of progesterone.)

According to the Centers for Disease Control and Prevention, one in four sexually active women in the United States has used Depo-Provera. Black women use it at almost twice the national rate.

Meningiomas are usually not cancerous, meaning they do not spread to other parts of the body, but they can be harmful depending on their size and where they grow. The overall risk of developing a meningioma remains low: approximately 39,000 meningiomas are diagnosed each year in the United States.

In a court filing this year, Pfizer asked a judge to dismiss the suit, saying it became aware of the meningioma risks associated with Depo-Provera in 2023 and February 2024. he submitted a request to the FDA to add a warning to the drug’s label. The request also asked to add warnings to two pills containing much lower doses of medroxyprogesterone acetate (MPA), the drug used in the injection.

The FDA denied that request, according to the filing, saying that “the results of available observational studies alone do not support adding a meningioma risk warning to products containing medroxyprogesterone acetate (MPA).” »

The company then amended and resubmitted its application to the FDA in June 2025.

In response, the FDA this month approved a label change for two versions of the injection – Depo-Provera CI and Depo-Subq Provera 104.

“We acknowledge receipt of your amendment dated June 12, 2025,” the FDA letter to Pfizer said. The approval “provides for the addition of information relating to the risk of meningioma” to the drug label.

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

“Pfizer supports the safety and effectiveness of Depo-Provera, which has been used by millions of women around the world and remains an important treatment option for women seeking to manage their reproductive health,” the statement said.

Lawyers for the women suing Pfizer said: “For years, Pfizer misled doctors, patients and the FDA about the link between Depo-Provera and meningiomas, resulting in unnecessary suffering for thousands of women who developed these dangerous brain tumors. … We applaud the FDA for finally requiring this label change to better inform and protect women.”

The FDA did not immediately respond to a request for comment.

In other parts of the world, a warning about the risk of meningioma has already been added to the drug label.

In 2024, the European Medicines Agency added meningioma as a “possible side effect” of medicines containing high doses of medroxyprogesterone acetate. That same year, the drug’s Canadian label was updated to include meningioma in the “Warnings and Precautions” section, stating that “meningiomas have been reported following long-term administration of progestins, including medroxyprogesterone acetate.”

In January, the South African Medicines Regulatory Agency also recommended updating the drug label for MPA to include the risk of meningioma.

The judge has not yet made a decision in the case against Pfizer in the United States.