FDA approves adding brain tumor warning label to Pfizer’s Depo-Provera birth control shot

Pfizer Depo-Provera MDL overview: 

• Who: The U.S. Food and Drug Administration reportedly approved adding a warning label to Pfizer’s birth control shot Depo-Provera. 
• Why: The label will now include a warning about the risk of developing a brain tumor known as a meningioma. 
• Where: The MDL is consolidated in Florida federal court. 
• What: If you were diagnosed with one or more meningiomas after using Depo Provera, you may be eligible for compensation. 

The U.S. Food and Drug Administration (FDA) reportedly approved a label change for Pfizer’s birth control shot Depo-Provera earlier this month. The label will now include a warning about the risk of developing a brain tumor known as a meningioma. 

The change comes amidst a lawsuit filed against Pfizer by more than 1,000 women arguing the company was aware of the risks of the shot yet failed to warn patients.

The litigation follows a 2024 study conducted by France’s National Health Data System that found a significant correlation between prolonged use of progestin-based medications — such as Depo-Provera — and the risk of developing intracranial meningiomas. 

The research discovered that long-term Depo-Provera users were up to five times more likely to develop a brain tumor, compared to individuals who never used the birth control shot. 

Amid subsequent lawsuits, the Judicial Panel on Multidistrict Litigation consolidated all of the complaints into a single MDL in Florida federal court in February 2025. The number of pending lawsuits in the MDL would ultimately surpass 1,300, as of September. 

CDC says more than 1 in 4 sexually active women in US have used Depo-Provera 

More than 1 in 4 sexually active women in the United States have used Depo-Provera, with Black women using the shot at nearly double the national rate, according to the Centers for Disease Control and Prevention. 

While meningiomas are not usually cancerous, they can still be harmful depending on their size and where they grow, according to the National Brain Tumor Society. The risk of developing a meningioma is also small, with around 39,000 cases diagnosed in the country each year. 

Pfizer previously asked a judge to dismiss the complaint earlier this year, arguing it only became aware of the risks associated with Depo-Provera in 2023 and that it submitted an application to the FDA to add a warning label in February 2024, reports NBC News. 

Within that request, Pfizer also reportedly asked for warnings to be added to two pills containing much lower doses of medroxyprogesterone acetate, the drug used in the Depo-Provera shot. 

The company, in its court filing, reportedly argued the FDA denied that request and that, in response, it amended and resubmitted its application to the FDA in June 2025, leading to the current label change approval, reports NBC News. 

In a separate case, Pfizer agreed to pay $35 million last year to resolve claims the company unlawfully kept generic versions of the cholesterol-lowering medication Lipitor off the market.

If you were diagnosed with one or more meningiomas after using Depo Provera, you may be eligible for compensation. 

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