Pfizer Updates Depo-Provera Warning Labels After Brain Tumor Reports

On Dec. 12, 2025, the FDA issued a letter to Pfizer that will require the manufacturer to change its warnings for its injectable birth control medication, Depo-Provera and Depo-Subq Provera 104. The new label warns that cases of meningiomas (benign brain tumors) have been reported following repeated use of medroxyprogesterone acetate (the primary active ingredient in Depo Provera), primarily with long term use. The label states that patients should be monitored for signs and symptoms of meningioma, and to stop using Depo-Provera if a meningioma has been diagnosed.

Depo-Provera is a progestin shot administered intramuscularly every three months in the upper arms or buttocks and has been on the market since 1992.

A meningioma is a type of brain tumor that is typically benign (non-cancerous). They are generally slow growing but can cause problems if they press on the brain, nerves and vessels, and cause headaches or vision issues. As a result, treatment for meningiomas often requires surgery (craniotomy) and/or radiation treatment.

More than 1,500 Plaintiffs have filed lawsuits against Pfizer, alleging Pfizer knew about the risks of Depo-Provera and meningiomas for decades and Pfizer refused to study or warn about the risk, ignoring epidemiological studies and doctors’ reports.

If you used Depo-Provera and have been diagnosed with a meningioma, you may have a compensable claim. Attorney Courtney Mohammadi was appointed to the Depo-Provera MDL Leadership team and can help evaluate your claim. Call the attorneys at Pope McGlamry today for a free and confidential consultation.

Pfizer’s Label Change Timeline

Below is a timeline regarding Pfizer’s request to change the label to the FDA:

2017

Dewata Study: Found increased meningioma risk after 10+ years of Depo-Provera use (odds ratio up to 4.45)¹.

February 2023

Abou-al-Shaar Study: 25 women with meningiomas linked to long-term Depo-Provera use.
Pfizer scientists flag this study during routine review².

June 2023

Roland Study (France): Results became available showing a statistically significant increased risk of meningioma with more than 1 year of Depo-Provera use (odds ratio 5.62). (The study was published in English in March 2024).

Late 2023

“Pfizer concluded that a potential causal association existed between long-term use of medroxyprogesterone acetate, or “MPA” (the active ingredient in Depo-Provera), and meningioma (a typically benign tumor).”³

February 2024

Pfizer submits request to FDA to add a warning about meningioma to Depo-Provera AND four other MPA-containing products.
Proposed warning on the 1st page of the label under the header “Warnings and Precautions”:
- “Meningioma: Discontinue if meningioma is diagnosed. Caution is advised when recommending Depo-Provera CI to patients with a history of meningioma.”
Pfizer also sought to provide a longer warning in the “Full Prescribing Information” portion of the label:
- 5.4 Meningioma: Meningiomas have been reported following long-term administration of progestins, including medroxyprogesterone acetate. Depo-Provera CI should be discontinued if a meningioma is diagnosed. Caution is advised when recommending Depo-Provera CI to patients with a history of meningioma.⁴.

September 2024

European Medicines Agency (the equivalent of the European FDA) requires a meningioma warning on Depo-Provera in Europe⁵.
Griffin Study (U.S.): Large-scale study shows statistically significant increased risk, stronger with longer use.⁶ It also reported higher meningioma risk for patients exposed to injectable MPA versus oral MPA.⁷

November 1, 2024

The FDA did not approve the requests in their present form, because “the findings of the available observational studies alone do not justify a warning on meningioma risk to medroxyprogesterone acetate (MPA)-containing products.”⁸
FDA invited Pfizer “to resubmit” its application to address “the deficiencies.” Pfizer could “request a meeting or teleconference” to discuss needed steps “before the applications may be approved.”⁹

February 25, 2025

Pfizer issued an official Important Safety Communication to healthcare professionals in South Africa informing them that, “The product information for [DMPA] will be updated… meningioma will be added as an adverse reaction[.]” Defendants explicitly stated that DMPA “is contraindicated in patients with a history of meningioma” and advised healthcare professionals to discontinue treatment if meningioma is diagnosed in patients using DMPA for contraception. Additionally, South African healthcare providers were instructed to monitor patients for meningioma symptoms and counsel them on the potential risks associated with Depo-Provera.

June 12, 2025

Pfizer resubmits updated label request to FDA, this time, for only its injectable birth control medication, Depo-Provera and Depo-Subq Provera 104 citing new evidence (Griffin Study) and EU actions.

December 12, 2025

The FDA issued a letter to Pfizer approving the amended label for Depo-Provera and Depo-Subq Provera 104.
The new label, and patient information cards, will now contain the following warnings about meningiomas:

New Label

5.4 Meningioma
Cases of meningiomas have been reported following repeated administration of medroxyprogesterone acetate, primarily with long term use. Monitor patients on Depo-Provera CI for signs and symptoms of meningioma. Discontinue Depo-Provera CI if a meningioma is diagnosed.

Warnings and Precautions:
Meningioma: Discontinue Depo-Provera CI if meningioma is diagnosed. Monitor patients for signs and symptoms of meningioma. (5.4)

References

¹See Defendants’ Motion for Summary Judgment, DE 414 at pg. 11.

²Id. at 7.

³Id. at 1.

⁴Id. at 9.

⁵Id. at 15.

⁶Id.

⁷See Plaintiffs’ Memorandum in Support of Their Opposition to Defendants’ Motion for Summary Judgment Based on Federal Preemption, DE 427 at pgs. 17.

⁸Id. at 10-11.

⁹Id. at 11.

¹⁰U.S. Food & Drug Administration, Approval Letter for NDA 020246/S-074 & NDA 021583/S-045 (Dec. 12, 2025), https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020246Orig1s074,021583Orig1s045ltr.pdf

Pfizer Updates Depo-Provera Warning Labels Following Brain Tumor Reports

Pfizer’s Label Change Timeline

New Label

Patient Information Cards

Contact Pope McGlamry

References

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Pope McGlamry Attorney, Courtney Mohammadi, Appointed to Plaintiffs’ Depo-Provera Leadership Team