Depo-Provera and Meningioma
Studies linked Depo-Provera — a contraceptive injection containing the synthetic hormone progestin — to a tumor in the lining of the brain called a meningioma. Pfizer, the drug’s maker, faces lawsuits claiming the drug led women to develop the tumor.
After a March 2024 study connected Depo-Provera to an increased risk of meningioma, Kristina Schmidt filed the first Depo-Provera lawsuit in October 2024. Schmidt’s lawyers claimed the birth control shot led to her meningioma diagnosis.
According to Schmidt’s attorneys, Pfizer never warned about the risk of meningioma tumors. Depo-Provera lawsuits claim that Pfizer was or should have been aware of the risk and had a duty to warn users.
However, the U.S. Food and Drug Administration (FDA) and other regulatory agencies haven’t issued specific warnings about the drug’s meningioma concerns in the United States.
How Does Depo-Provera Increase the Risk of Meningioma?
Meningiomas are hormone-sensitive tumors. Some scientists think that prolonged exposure to man-made progestin hormones like medroxyprogesterone acetate (MPA) — the active ingredient in Depo-Provera — may increase the risk by encouraging meningiomas to develop.
Progestin is a synthetic version of progesterone, a naturally occurring reproductive hormone. Researchers found that many meningiomas have specific hormone receptors for progesterone, which indicates that this hormone may play a role in tumor growth.
Meningiomas are also more common in women, further supporting the role female hormones play in tumor growth.
What Do Studies Say About Depo-Provera & Meningioma Risk?
There are a couple of key studies that directly link Depo-Provera use with an increased risk of meningioma. BMJ published the main study that prompted Depo-Provera lawsuits in March 2024. In the study, French researchers found a 5.55-fold increased risk of developing meningioma with Depo-Provera use for one year or more.
However, some researchers have pointed out the weaknesses of the March 2024 French study. For example, critics noted that the study had 18,000 meningioma patients, but only nine received intramuscular MPA, while many others “received other forms of progesterone with no association” to meningiomas. They also noted that the study’s findings meant that just five women out of 10,000 who used MPA would develop meningioma.
Another study published in the journal Cancers in September 2024 sought to verify the data from the previous study. This time, researchers analyzed Depo-Provera usage data from the United States. They found that the odds of developing meningioma were 53% greater in women who used injectable MPA versus those who did not.
Recognizing the Symptoms of Meningioma Linked to Depo-Provera
Because meningioma brain tumors develop slowly, it can be difficult to pinpoint symptoms (and easy to overlook them). It often isn’t until they grow large enough to cause problems that meningioma symptoms become apparent.
Meningioma symptoms also depend on the tumor’s location in the brain and the surrounding tissues or nerves. For example, a tumor that grows in the olfactory groove — the spot on the brain that controls smell — may lead to loss of smell.
Common Symptoms of Meningioma in Depo-Provera Users
The most common meningioma symptoms are a headache that lasts for weeks or months, paralysis or weakness, vision problems and speech problems. Small meningiomas are not likely to cause symptoms. In fact, the tumors may only be detected during routine exams.
Symptoms of meningioma could take time to develop. In the beginning, they may be subtle. A person with meningioma may live with mild symptoms for a while before being diagnosed.
- Difficulty speaking
- Headaches
- Hearing loss
- Memory loss
- Numbness
- Seizures
- Vision problems
- Weak arms or legs
“In some patients, if the tumor is near the optic nerve, [it] can also affect vision. Or if it’s close to your auditory structure, it can affect hearing as well,” Dazhi Liu, an oncology clinical pharmacy specialist, told Drugwatch.
When to Seek Medical Evaluation for Meningioma Concerns
If you have used Depo-Provera and experience any of the symptoms listed above, you should discuss them with your medical provider.
Slow-growing tumors that don’t cause symptoms aren’t an emergency, but if you experience more severe symptoms, you should seek care right away. Seizures and sudden memory or vision issues are severe symptoms that require emergency care.
“In some patients, if the tumor is near the optic nerve, [it] can also affect vision. Or if it’s close to your auditory structure, it can affect hearing as well.”
Did Pfizer Know About the Meningioma Risks of Depo-Provera?
According to Depo-Provera lawsuits, Pfizer “knew or should have known for decades that Depo-Provera, when administered and prescribed as intended, can cause or substantially contribute to the development of meningiomas.”
Internal Research & Industry Knowledge of Hormonal Brain Tumor Risks
Plaintiffs’ legal complaints reference research and industry knowledge establishing that progesterone, its man-made analog progestin and Depo-Provera use all contribute to meningioma tumor growth. They claim Pfizer and its subsidiary Upjohn (which Pfizer acquired in 2002) had access to these studies.
For example, lawsuits cite studies as far back as 1983 that showed meningioma had a high number of progesterone receptors. This discovery could have signaled that a progestin birth control drug like Depo-Provera carried meningioma risks. Lawsuits note that these studies were available many years prior to Depo-Provera’s 1992 FDA approval for contraception, yet Pfizer “seemingly” did nothing to investigate them.
How Has Pfizer Responded to Depo-Provera Health Concerns?
Shortly after researchers published the March 2024 study linking Depo-Provera to meningioma brain tumors, Pfizer released the following statement: “We are aware of this potential risk associated with long-term use of progestogens and, in collaboration with regulatory agencies, are in the process of updating product labels and patient information leaflets with appropriate wording.”
Pfizer published the most recent Depo-Provera U.S. prescribing label in July 2024, which contains no mention of meningioma. However, while the FDA didn’t take action, some other countries updated safety information after the March 2024 study.
For example, the approved Depo-Provera prescribing label for the United Kingdom and Pakistan warns: “Meningiomas have been reported following long-term administration of progestogens, including medroxyprogesterone acetate. Depo-Provera should be discontinued if a meningioma is diagnosed. Caution is advised when recommending Depo-Provera to patients with a history of meningioma.”
What Have Health Agencies Said About Depo-Provera Brain Tumors?
So far, the FDA has not acted to warn the public, and the World Health Organization (WHO) hasn’t issued a specific statement about Depo-Provera’s potential meningioma risk.
The European Medicines Agency linked prolonged use of Depo-Provera to an increased risk of meningioma and recommended adding warnings to the prescribing information for injectable MPA and oral formulas that contain 100 mg or more of MPA.
No countries have yet banned Depo-Provera, though this could change if more studies provide additional data supporting the meningioma link. In the U.S., the most substantial warning on the Depo-Provera label is a black box warning for bone loss.
The Legal Fallout From Depo-Provera & Meningioma Cases
After the first study linking Depo-Provera to meningioma came out in March 2024, lawsuits from people who suffered from meningiomas after using the birth control shot began to trickle in.
- Failure to Warn: Defendants knew or should have known that Depo-Provera’s warnings about meningioma were inadequate based on available data.
- Design Defect: Depo-Provera’s high-dose progesterone design gave it an unreasonable risk of meningioma, making it a defective product.
Other causes of action in lawsuits include negligence, negligent misrepresentation and fraudulent misrepresentation.
Have There Been Previous Hormone-Linked Tumor Lawsuits?
Pfizer has previously faced similar legal challenges due to hormone-linked tumors. In 2012, the company settled about 6,000 lawsuits related to Prempro — a hormone replacement therapy (HRT) linked to breast cancer — for $896 million. Pfizer also set aside an additional $330 million to cover roughly 4,000 outstanding Prempro lawsuits, for a total of about $1.23 billion for 10,000 cases.
The Depo-Provera lawsuits may follow a similar path if evidence shows that Pfizer was aware of the tumor risk but failed to act. As of April 2025, there were 130 Depo-Provera lawsuits pending in a Florida federal court.
What Should Patients Do if They’re Concerned About Meningioma?
If you are concerned about developing a meningioma from using Depo-Provera, you should discuss the risks and benefits with your doctor. For some people, the risk of meningioma may be negligible compared to the risk of pregnancy. However, only you and your doctor can decide this.
You may also decide to use another form of birth control. Keep in mind that all forms of birth control have some risks, and you should find the one that works best for you.
Diagnosing Meningioma
To diagnose a meningioma tumor, doctors most often use magnetic resonance imaging (MRI) to create images of the brain structures. In people who can’t receive an MRI, doctors use computed tomography (CT) scans that use multiple X-rays to get a picture of the brain’s structures.
Doctors may also perform a biopsy by using a needle to collect a sample of the tumor’s cells. Analyzing these cells can confirm the diagnosis and determine if the tumor is benign or cancerous.
What to Do if You’re Diagnosed With a Depo-Provera Brain Tumor
If your doctor diagnoses you with meningioma after using Depo-Provera, you may want to discuss the March 2024 study and subsequent September 2024 study. These could help your doctor determine if Depo-Provera use contributed to your meningioma brain tumor.
Next, review all of the meningioma treatment options with your doctor. If the tumor is small and not causing significant problems, your doctor may decide to monitor it. On the other hand, if the case is severe, you may require surgery to remove the tumor.
If you decide to get a second opinion, request a complete copy of your medical records from your current doctor, including any potential X-rays or diagnostic test results. You will also need your medical records if you want to file a Depo-Provera lawsuit.
Who Is Most at Risk for Developing Meningioma?
Meningiomas are more common in women. Data suggest that these tumors are sensitive to female hormones, such as progesterone and estrogen. Genetics, obesity and radiation treatment to the head also increase the risk.
In the case of Depo-Provera, the BMJ study also showed that women who used the drug for one year or more had a higher risk of developing meningioma.
Where to Find More Information on Depo-Provera Safety
If you want to keep up with the latest Depo-Provera safety information, you can always check Drugwatch for the latest news. You can also review the resources below:
- Pfizer Prescribing Information. Pfizer’s prescribing information details clinical study results and safety information for other noted Depo-Provera side effects.
- Planned Parenthood. This nonprofit organization provides more information on Depo-Provera safety, effectiveness and benefits.
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