UPDATE:
This week, the FDA approved a label change on Depo Provera, requiring its maker, Pfizer, to warn women about links between use of the birth control injection and brain tumors known as meningiomas.
The FDA told Pfizer it can add information related to the risk onto Depo Provera’s packaging and must submit the content for that label in the next two weeks.
This marks a major shift, as the FDA had previously rejected Pfizer’s bid to update the label in 2024, although some in the legal community suggest Pfizer intentionally submitted a substandard request, knowing the FDA would reject it, thus allowing the company to use the rejection as a legal defense.
There is a growing body of scientific research identifying the risk, with a recent study showing women were about 5.5 times more likely to develop a meningioma compared to women not using hormonal contraceptives.
Women in Canada and the EU have been warned about a link between Depo Provera and brain tumors since as far back as 2022, but no such warning has ever existed for American women.
More than 2,000 women are suing Pfizer in America over meningiomas they believe are linked to Depo Provera. Leading attorneys in those cases issued the following statement:
“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. Pfizer’s knowledge of this risk goes back decades, yet there was no warning provided. We applaud the FDA in finally requiring this label change to better inform and protect women. We are committed to pursuing justice for the thousands of women whose lives were shattered when they developed brain tumors caused by Depo-Provera and suffered lasting neurological damage, vision loss, and death due to Pfizer’s misconduct.”
We’ll continue to closely follow that case as it proceeds.
======================================================================================================================
For months, the 7News I-Team has investigated possible links between the injectable birth control Depo-Provera and a type of brain tumor known as meningioma.
Women from across the United States have shared their experiences with us. Now, newly obtained court transcripts raise additional questions about what the drug’s manufacturer, Pfizer, disclosed to federal regulators about the risks.
A Devastating Diagnosis
For millions of women, birth control is supposed to bring peace of mind. For Randi Hickman, it changed her life forever.
She was alone in a doctor’s office during the height of the pandemic when she received her diagnosis.
Randi Hickman was diagnosed in 2020 at the height of the pandemic. Because of Covid restrictions, she was alone in the doctor’s office and received the devastating news of a brain tumor from a physician on a computer screen. (Photo: SBG)“They said, ‘We’re admitting you to the hospital — you have a brain tumor,'” said Hickman.
Hickman survived emergency brain surgery, but the aftermath has been brutal. She now lives with chronic pain, ocular seizures and a surgical scar that wraps nearly halfway around her head.
The surgical wound from Hickman’s ordeal left a nearly 180-degree scar. (Photo courtesy: Randi Hickman)
Only after her operation did she learn of emerging research linking prolonged use of Depo-Provera to a sharply increased risk of meningioma.
Women in Canada and Europe are warned on the product’s labeling. In the United States, they are not.
A French study found an increased risk of meningioma associated with Depo-Provera (Photo: SBG)
Lawsuit Pushes Forward
“Thousands of women are affected,” said attorney Ellen Relkin.
Relkin, who sat down for an interview with us in July of 2025, is suing Pfizer on behalf of women like Hickman, alleging the company failed to provide American patients with the same safety warnings provided overseas.
Attorney Ellen says while Depo Provera sold in the EU and Canada bears warnings of potential brain tumors, the same product in the US carries a black box warning for loss of bone density. (Photo: SBG)
Pfizer is asking a federal court to dismiss the lawsuit, citing the Food and Drug Administration’s rejection of label warning changes Pfizer proposed last year.
In our interview from over the summer, Relkin argued the company anticipated that outcome.
“It’s the new tool book. Give a half-hearted, half-baked request to the FDA, hoping that it’s denied because of its inadequacy, and then once they got the rejection, that’s their litigation defense,” Relkin said.”
What the Transcripts Show
Newly reviewed court transcripts appear to support Relkin’s concern.
According to the transcripts from the September 2025 hearing in which Pfizer is asking a judge to dismiss the case, the company argued that the FDA’s rejection letter carries “the force of law,” meaning the company believes the agency’s denial shields Pfizer from liability for not warning American women about the potential brain tumor risk.
Relkin said the legal strategy is not new and has previously failed in similar cases.
She said manufacturers can update warnings without advance FDA approval.
“There’s an alternative route called CBE, “Changes Being Effected,” and they can on their own, within certain constraints, change the label to warn of anything that they believe is important.” said Relkin.
Significant Redactions
Large portions of the 113-page transcript are blacked out, including sections immediately following allegations that Pfizer withheld some safety information from U.S. regulators while providing more to European authorities.
Based on the surrounding context, those redacted passages appear to involve details of what Pfizer told regulators — and what it did not.
For Hickman, and many women like her, those omissions are personal.
“We deserve better than this,” said Hickman. “We deserve to know what we’re putting in our bodies.”
Depo-Provera was the first hormone shot to prevent pregnancy for several months at a time. (FILE)
What Happens Next
Nine months ago, the 7News I-Team filed Freedom of Information Act requests for the complete correspondence between Pfizer and the FDA. No documents have yet been provided.
Pfizer declined our request for an interview, citing that it had no one available to speak with us. The company did provide this statement via email:
Pfizer believes these claims are without merit and will vigorously defend against these allegations. The Company 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.
More than 1,000 women are currently suing the company. Relkin said the true number of affected patients may never be known because, unlike women in Canada and Europe, U.S. patients and physicians were not warned that persistent headaches, dizziness and visual disturbances could be signs of Depo-Provera-associated meningioma.
Whether the lawsuit proceeds is now before a federal judge. Relkin said she is optimistic, pointing to a similar case involving the drug Fosamax 15 years ago in which a comparable defense was rejected by the court.
The 7News I-Team will continue to monitor developments and report updates as the case progresses.
How Depo-Provera Warnings Differ Around the World
United States
- No warning for meningioma or brain tumors
- Current black box warning concerns loss of bone mineral density
- No requirement for monitoring neurological symptoms
- Pfizer notes the FDA declined proposed warning-label changes in 2023 due to the agency’s assessment of the submitted data
Canada
- Explicit tumor caution included
- Health Canada label states: “Meningiomas have been reported (rarely) with long-term use of medroxyprogesterone acetate.”
- Advises clinical evaluation if women report persistent neurological symptoms
- Issued updated safety communication in 2022 following review
Source: Government of Canada – Depo-Provera / Medroxyprogesterone acetate Product Monograph (2022)
European Union
- Formal risk alert and monitoring recommendation
- The EMA updated guidance in late 2022, advising:
- “Patients should be monitored for clinical signs and symptoms of meningioma.”
- Recommends discontinuation if a meningioma is diagnosed
- Acknowledges that shrinkage of tumors has been observed after stopping use of Depo Provera
Source: European Medicines Agency, Pharmacovigilance Risk Assessment Committee (PRAC) recommendation, October 2022, later updated in 2024
What It Means for Patients
- U.S. patients and clinicians receive no notification about a potential tumor association.
- Canada and the EU explicitly instruct providers to watch for signs such as persistent headaches, dizziness and visual changes.
- Women in the U.S. may miss early warning symptoms because they have not been advised to connect neurological changes with a possible drug-related tumor.
