The Food and Drug Administration approved a label change Friday for Pfizer's birth control injections. Depo-Provera This alerts patients to the risk of meningioma, a tumor in the lining of the brain.
Pfizer I'm currently in litigation 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 progestin injections every three months. The lawsuit cites several studies dating back to 1983 showing a link between progesterone and meningioma, and says those studies created a “compelling duty to investigate” and that Pfizer should have studied the risks associated with Depo-Provera earlier. (Progestin is a synthetic version of progesterone.)
According to Centers for Disease Control and PreventionOne in four sexually active women in the United States has used Depo-Provera. Black women use it at nearly twice the national rate.
Meningiomas are usually not cancerous—that is, 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 meningioma remains small: about 39,000 meningiomas diagnosed every year in the USA
In a court filing this year, Pfizer asked a judge to dismiss the lawsuit, saying it became aware of the meningioma risks associated with Depo-Provera in 2023 and February 2024. This filed an application with the FDA to add a warning to the drug's label. The application also sought to add warnings to two tablets containing much lower doses of medroxyprogesterone acetate (MPA), the drug used in the shot.
According to the statement, the FDA denied the request, stating that “the results of available observational studies do not, in and of themselves, 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 label changes for two versions of the shot, Depo-Provera CI and Depo-Subq Provera 104.
“We acknowledge receipt of your amendment dated June 12, 2025,” the FDA said in a letter to Pfizer. The approval “involves adding information about the risk of meningioma” to the drug's label.
In a statement to NBC News, a Pfizer spokesperson said the “label update reflects the FDA's recent decision to approve a warning that the agency had previously denied.”
“Pfizer stands by 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 take control of their reproductive health,” the statement said.
Lawyers for the women suing Pfizer said: “For years, Pfizer misled doctors, patients and the FDA about Depo-Provera's association with meningiomas, resulting in unnecessary suffering for thousands of women who developed these dangerous brain tumors… We applaud the FDA for finally requiring a change to this label 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's label.
In 2024 European Medicines Agency added meningioma as a “possible side effect” of high-dose medroxyprogesterone acetate drugs. That same year, the drug's Canadian label was updated to include meningioma in its Warnings and Precautions section, stating that “meningiomas have been reported following long-term use of progestins, including medroxyprogesterone acetate.”
In January The South African Medicines Regulatory Agency also recommended updating the MPA drug label to include the risk of meningioma.
A judge has yet to rule on the case against Pfizer in the US.
