The Food and Drug Administration approved on Friday a label change for Pfizer’s birth control shot Depo-Provera that warns patients of the risk of meningioma, a tumor 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 points to several studies dating as far back as 1983 showing a link between progesterone and meningioma, saying those studies created an “unassignable 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, 1 in 4 sexually active women in the United States have used Depo-Provera. Black women use it at nearly double the national rate.
Meningiomas are usually not cancerous — meaning they don’t 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 small: About 39,000 meningiomas are diagnosed each year in the U.S.
In a court filing this year, Pfizer asked a judge to dismiss the lawsuit, saying it became aware of the risks of meningioma associated with Depo-Provera in 2023, and in February 2024 it submitted an application to the FDA to add a warning to the drug’s label. The application also requested adding warnings to two pills containing much lower doses of medroxyprogesterone acetate (MPA), the drug used in the shot.
The FDA denied that request, according to the filing, saying “the findings of the available observational studies alone do not support the addition of a warning on Meningioma risk to medroxyprogesterone acetate (MPA)-containing products.”
The company then amended and resubmitted its application to the FDA in June 2025.
In response, the FDA this month approved a change to the label 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 related to Meningioma risk” on the drug’s 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 earlier denied.”
“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,” the statement said.
Lawyers for the women suing Pfizer said: “For years, Pfizer misled doctors, patients and the FDA about Depo-Provera’s link to meningiomas, resulting in the needless suffering of thousands of women who developed these dangerous brain tumors. … We applaud the FDA in 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 meningioma risk warning has already been added to the drug’s label.
In 2024, the European Medicines Agency added meningioma as a “possible side effect” of drugs with high doses of medroxyprogesterone acetate. That same year, Canada’s label for the drug was updated to include meningioma in its “warnings and precautions” section, stating that “meningiomas have been reported following long-term administration of progestins, including medroxyprogesterone acetate.”
In January, South Africa’s drug regulatory agency also recommended updating the drug label for MPA to include meningioma risk.
The judge has yet to issue a decision in the case against Pfizer in the United States.
This article was originally published on NBCNews.com
