FDA approves new brain tumor warning label on Depo Provera birth control shot 

One of the many dangers associated with this drug
depo provera shot, birth control, depo warning

As of December 2025, the Depo Provera birth control shot patient product information now contains a warning that use increases risk of benign brain tumors called meningiomas. Directly beneath the existing black box warning about risk of bone mineral density loss with Depo use, a new heading on page one reads “Recent Major Changes: Warnings/Precautions, Meningioma.” 

Also on page one, under “Warnings and Precautions,” users are advised to discontinue use immediately if a meningioma is diagnosed. This is easier said than done, since the effects of a Depo Provera shot last for at least three months. Later on, the pamphlet notes that meningiomas have been reported with Depo use, particularly long-term. 

While meningiomas are not typically cancerous, and therefore will not spread throughout the body, their size and location can make them dangerous (as one example, one woman who had a meningioma form near her optic nerve lost vision in her left eye, and had to relearn how to walk, after her meningioma was removed during an emergency surgery). As of 2023, according to the CDC, 25% of women had used Depo Provera at some point, and rates were roughly twice as high in Black women. As Natural Womanhood has noted before, women with intellectual disabilities are also more likely to receive the Depo Provera shot.  

Who initiated the Depo Provera label change?

In February of 2024, Pfizer petitioned the FDA to update the label for the Depo Provera shot as well as several other medications, including the shot’s main ingredient, medroxyprogesterone acetate, though at much smaller doses. At that time, Pfizer maintained that they had only recently learned of the meningioma-Depo connection in 2023. 

Just one month later, a landmark French study found that while the overall meningioma risk was very low (.0.05%) even in “long-term” users (meaning 12 consecutive months or more), it was 5.6x higher than in women who weren’t on Depo (0.01). 

In November of that year, Natural Womanhood reported that over 1,300 lawsuits had been filed in state and federal courts, alleging that drug manufacturer Pfizer failed to disclose the known risk, among other allegations. As of January 2026, over 1,750 lawsuits have been filed, per the website Lawsuit Tracker. Many have been consolidated into multidistrict litigation, which lumps together like-cases to avoid conflicting rulings, duplication of services, and unnecessary inconvenience for both those filing lawsuits and the court system. 

Pfizer’s first label change application was rejected by the FDA

Pfizer’s first petition to update the drug label was rejected by the FDA, whose denial read, in part, “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,” according to NBC News

The FDA’s initial denial was surprising given that, as Natural Womanhood previously explained, studies linking meningioma and medroxyprogesterone acetate use date back to the 1980s. 

Pfizer submitted a second petition in June of 2025, which was approved in December. According to Consumer Notice, in August of 2025, Pfizer requested that the multidistrict litigation be thrown out without going to trial, claiming that it cannot be held liable for meningioma cases when the FDA had previously rejected the company’s application for a label update. 

Meningioma is far from the only risk with Depo Provera use

While the Depo Provera labeling change is a welcome step in pursuit of fully informed consent for women using it for contraception, meningioma risk is just one among the many dangers associated with this drug. As Natural Womanhood shared previously, other Depo Provera risks include weight gain, breast cancer, increased transmissibility of HIV (this is especially concerning given the popularity of Depo in sub-Saharan countries, where ⅔ of all worldwide cases occur), and bone mineral density loss. 

While the Depo Provera labeling change is a welcome step in pursuit of fully informed consent for women using it for contraception, meningioma risk is just one among the many dangers associated with this drug. As Natural Womanhood shared previously, other Depo Provera risks include weight gain, breast cancer, increased transmissibility of HIV (this is especially concerning given the popularity of Depo in sub-Saharan countries, where ⅔ of all worldwide cases occur), and bone mineral density loss. 

For young women in particular, the evidence against Depo is most damning, since it causes them to actively lose bone mineral density during the years when they should have the highest bone mineral density levels of their lives. 

Is self-injectable Depo Provera next?

On the one hand, Depo Provera is under public scrutiny for its previously undisclosed link with brain tumors. On the other hand, as reported by U.S. News and World Report, some medical practitioners are advocating for FDA approval of a self-injectable version, known as the Sayana Press. Sayana Press has been available for at-home use in the UK since 2015, and international aid entities like this one are openly advocating for its use particularly in low income countries

Certainly, women can learn to inject medications at home, as many pregnant women prescribed progesterone shots by NaProTechnology-trained healthcare professionals will attest. But the known safety risks of Depo arguably make its self-injectable cousin, the Sayana Press, a very poor candidate for further dissociation from medical supervision and ongoing oversight. 

The known safety risks of Depo arguably make its self-injectable cousin, the Sayana Press, a very poor candidate for further dissociation from medical supervision and ongoing oversight. 

The bottom line

Now that the FDA has formally acknowledged the link between meningioma and Depo Provera use, multidistrict litigation and other lawsuits from past users are likely to move forward rather than be thrown out without a trial as Pfizer had requested, according to Dillon White, an attorney (and popular content creator behind thedadchats Instagram account), who currently represents multiple women affected by meningioma after Depo use. 

On December 16, 2025, White posted a video describing the FDA approval of Pfizer’s label change, calling it “a monumental day” for the lawsuits against Pfizer. 

But will women finally receive justice for specific damages caused by their birth control shot use? More broadly, will Depo Provera fall from favor, and will women be offered family planning alternatives that don’t jeopardize their health? Will Sayana Press (a favorite project of The Gates Foundation) continue to make inroads in developing countries—and perhaps become available in the United States? Stay tuned. 

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