Depo-Provera Meningioma Side Effects Significantly Increased Among Women Over 31: Study

Cleveland Clinic researchers estimate side effects of Depo-Provera may cause meningioma brain tumors in one out of every 1,152 women who receive the birth control shots.

According to the findings of a new study, women over 31 years of age receiving Depo-Provera injections, as well as those who have been on the birth control shot for several years, face significantly higher risks of developing meningioma brain tumors than their peers.

In a report published online by the medical journal JAMA Neurology on September 2, researchers from the Cleveland Clinic indicate that there is a direct link between use of Depo-Provera and intracranial meningiomas, with the highest risks seen in women over a certain age and those who used the injections for at least four years.

Depo-Provera (depot medroxyprogesterone acetate) is a long-acting hormonal contraceptive administered every three months. It has been used by tens of millions of women over the past three decades that it has been on the market, based on the belief that it is a safe and effective form of birth control, which does not require a daily pill.

However, concerns about potential Depo-Provera meningioma side effects emerged last year, when a groundbreaking study was published that found women receiving the birth control shot may face a five-times higher risk of developing the brain tumor, which can cause vision changes, headaches and neurological impairment.

In the wake of these findings, women nationwide have filed about 1,000 Depo-Provera meningioma lawsuits, indicating Pfizer, the manufacturer, and generic makers of the birth control shot knew or should have known about the brain tumor risk and failed to warn women or the medical community. In addition, researchers have been taking a closer look at quantifying the risk that different groups of women may face.

In a new study released this week, Dr. Tianqi Xiao and colleagues conducted a retrospective, population-based cohort analysis using data from more than 10 million women in the TriNetX database. They compared meningioma incidence rates among women who received Depo-Provera injections, took an oral version of the drug, used other forms of birth control such as oral contraceptives, IUDs, progestin-only pills or subdermal implants, and those who did not use birth control at all.

The researchers found that those who received Depo-Provera injections faced a 2.43-fold higher risk of developing intracranial meningiomas compared to women who did not use the drug. The danger was concentrated among women who began treatment after age 31, or used the shots for more than four years, the equivalent of at least 16 injections.

“In this study, women receiving depot medroxyprogesterone acetate had a greater relative risk of subsequent meningioma diagnosis, especially with prolonged exposures and starting the medication at older ages.”

– Cleveland Clinic researchers

By contrast, only a modest increase in risk was seen with oral medroxyprogesterone acetate, and no association was found with other contraceptives, such as oral birth control pills, IUDs, progestin-only pills or implants. 

Researchers estimated one additional case of meningioma would occur for every 1,152 women who used Depo-Provera. With more than 70 million women in the United States believed to have received the injections, the findings suggest thousands of preventable brain tumors may already have developed.

Depo-Provera Meningioma Lawsuits

The data provides additional supporting evidence for women pursuing Depo-Provera meningioma lawsuits, which have been filed throughout the federal court system and consolidated in the Northern District of Florida, where U.S. District Judge M. Casey Rodgers is presiding over coordinated discovery and pretrial proceedings in a Depo-Provera MDL (multidistrict litigation).

As part of the management of the litigation, Judge Rodgers has ordered the parties to prepare a small group of pilot test cases for early “bellwether” trial dates. These trials are designed to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation. However, before the evidence is presented in open court, plaintiffs must overcome a series of anticipated pretrial motions seeking to have the litigation thrown out.

Late last month Pfizer filed a motion for summary judgment, claiming that the state-law based failure-to-warn claims are preempted by federal law, and that the U.S. Food and Drug Administration did not allow Pfizer to add a meningioma warning label in 2023 when the company requested it.

If the litigation survives the preemption challenge, the parties will move ahead with the bellwether trials.

Although the outcomes of those trials will not be binding on other claims, they are expected to provide critical insight into how juries respond to key arguments and testimony, potentially paving the way for broader Depo-Provera settlement negotiations.

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