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

Cleveland Clinic researchers estimate Depo-Provera meningioma side effects will harm one out of every 1,152 women who receive the injections.

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 brain tumors than their peers.

Researchers from the Cleveland Clinic reported in JAMA Neurology on August 2, that Depo-Provera is linked to 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.

A groundbreaking study published last year found that women receiving the birth control shot may face a five-times higher risk of developing an intracranial meningioma, a type of brain tumor that can cause vision changes, headaches and neurological impairment. Researchers further warned these meningioma side effects sometimes require the need for brain surgery and life-long medical monitoring.

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 the new study, 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 under U.S. District Judge M. Casey Rodgers as a Depo-Provera MDL (multidistrict litigation) for coordinated discovery and pretrial proceedings.

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.

To stay up to date on this litigation, sign up to receive Depo-Provera lawsuit updates sent directly to your inbox.