December 17, 2025

Depo-Provera and Brain Tumors: What Patients Should Know Summary : The FDA has approved a label change for Pfizer’s birth control injection Depo-Provera, adding a warning about meningioma, a type of brain tumor. This decision reverses the FDA’s earlier rejection of a similar request in 2024. More than 2,000 women in the U.S. are suing Pfizer, alleging the company failed to warn about the risk despite decades of scientific evidence. Studies suggest women using Depo-Provera may be up to 5.5 times more likely to develop meningioma compared to non-users. Canada, the EU, and other countries have included meningioma warnings on Depo-Provera labels since 2022–2024. Plaintiffs allege Pfizer delayed or withheld safety information from U.S. regulators while providing stronger warnings overseas. The newly approved U.S. label states that meningioma cases have been reported with repeated use and advises caution for patients with prior meningioma history. A federal judge has not yet ruled on whether the lawsuits against Pfizer will proceed.   FDA Approves Brain Tumor Warning for Depo-Provera The U.S. Food and Drug Administration (FDA) has approved a significant label update for Depo-Provera, Pfizer’s injectable birth control shot. The revised labeling now warns patients and healthcare providers about a potential link between repeated use of the drug and meningioma, a tumor that forms in the lining of the brain. The approval marks a major shift in regulatory stance after the FDA previously declined to allow such a warning in 2024. What Is Depo-Provera? Depo-Provera is a progestin-based contraceptive injection administered once every three months. It contains medroxyprogesterone acetate (MPA), a synthetic form of the hormone progesterone. According to the Centers for Disease Control and Prevention (CDC): About 1 in 4 sexually active women in the U.S. have used Depo-Provera. Black women use the drug at nearly twice the national average, raising concerns about disproportionate health impacts. Understanding Meningioma Risk Meningiomas are typically non-cancerous brain tumors, but they can cause serious harm depending on their size and location. Approximately 39,000 meningiomas are diagnosed annually in the U.S. Symptoms may include: Persistent headaches Vision changes Dizziness Seizures Recent research shows women using Depo-Provera may face a 5.5-fold increased risk compared to non-users. Lawsuits Against Pfizer Pfizer is currently facing lawsuits from more than 2,000 women across the United States who allege: The company knew about the potential link between progesterone-based drugs and meningioma for decades. Scientific studies dating back to 1983 suggested hormonal involvement in tumor growth. Despite this, Pfizer allegedly failed to adequately warn U.S. patients and physicians. Attorneys for the plaintiffs argue Pfizer had an “unassignable duty to investigate” and should have studied and disclosed the risks much earlier. Allegations of Delayed Warnings and Legal Strategy Court transcripts from 2025 reveal that Pfizer attempted to dismiss the lawsuits by citing the FDA’s earlier rejection of a label update, arguing that the denial carried “the force of law.” However, attorneys for the plaintiffs argue: Drug manufacturers can independently update labels using a regulatory pathway called CBE (Changes Being Effected) when safety concerns arise. Pfizer allegedly submitted an incomplete or weak request to the FDA in 2024, anticipating rejection, and then used that rejection as a legal defense. Large portions of court transcripts remain heavily redacted, particularly sections involving communications between Pfizer and regulators. FDA’s Final Decision in 2025 After Pfizer amended and resubmitted its application in June 2025, the FDA approved the warning this month. The updated label for: Depo-Provera CI Depo-Subq Provera 104 now states that: Meningioma cases have been reported with repeated use. Physicians should inform patients with a history of meningioma about the potential risk. Pfizer’s Response In a statement, Pfizer said: The label update reflects a new FDA decision. The company continues to stand by the safety and efficacy of Depo-Provera. Pfizer maintains that the lawsuits are without merit and says it will vigorously defend itself. Pfizer declined to provide interviews regarding the ongoing litigation. How Warnings Differ Around the World? United States No prior meningioma warning until now The existing black box warning focuses on bone mineral density loss No prior guidance on neurological symptom monitoring Canada Explicit meningioma warning added in 2022 Advises medical evaluation for persistent neurological symptoms European Union EMA issued formal warnings in 2022 and expanded in 2024 Recommends monitoring for meningioma symptoms Advises discontinuation if a tumor is diagnosed Notes tumors may shrink after stopping the drug Other Countries South Africa and others have also updated safety guidance for MPA-based drugs What This Means for Patients U.S. women were not warned for years about symptoms that could indicate a drug-related brain tumor. Many plaintiffs say early symptoms such as headaches and vision changes, were overlooked. The new label may help patients and doctors recognize risks sooner and make informed decisions. As one patient stated: “We deserve to know what we’re putting in our bodies.” What Happens Next A federal judge has yet to decide whether the lawsuits will proceed. Freedom of Information Act (FOIA) requests seeking full FDA-Pfizer correspondence remain unanswered. Legal experts note that similar defenses by drug manufacturers have failed in past cases. The case against Pfizer could set a major precedent for pharmaceutical transparency and patient safety in the United States. References: https://www.nbcnews.com/health/womens-health/fda-approves-label-change-depo-provera-adding-brain-tumor-warning-rcna249568 https://komonews.com/news/spotlight-on-america/legal-fight-intensifies-over-depo-provera-and-brain-tumor-allegations-drugs-pharmaceuticals-meningioma-pfizer-canada-europe-united-states-birth-control https://vocal.media/trader/fda-adds-brain-tumor-warning-to-depo-provera-as-lawsuits-against-pfizer-intensify