In a pivotal development for women’s health, the ongoing debate over the injectable contraceptive Depo-Provera reached a critical juncture in December 2025, when the U.S. Food and Drug Administration (FDA) officially approved a revised label for the medication. This new warning highlights a potential association between long-term use of Depo-Provera and the risk of developing meningioma, a type of brain tumor.
This significant change comes amid a rising tide of legal action against Pfizer, the drug’s manufacturer. Plaintiffs allege that the company neglected to adequately inform users about the serious health risks associated with the contraceptive. For decades, Depo-Provera has provided a convenient birth control solution for millions, administered every three months, thereby alleviating the need for daily pill intake. However, recent studies and a growing legal chorus have raised serious concerns regarding its long-term safety.
Historically, the label for Depo-Provera predominantly highlighted well-documented side effects, including bone density loss and blood clot risks, while omitting any mention of meningioma, even as other countries—including Europe, Canada, and Australia—had already included warnings about this potential risk.
The newly updated FDA label indicates that “meningioma cases have been reported with repeated use of Depo-Provera,” urging healthcare providers to advise patients who may face such risks. This change reflects an increasing body of scientific evidence suggesting that long-term use of progestin injections could significantly heighten the likelihood of developing meningioma, particularly among women using the contraceptive for over a year.
For many advocates and women involved in ongoing lawsuits, the FDA’s label modification is a long-awaited measure toward transparency. They argue, however, that it does not sufficiently acknowledge how long the risks went unnoticed and the subsequent suffering experienced by many. Consequently, over 1,200 women in the United States have filed lawsuits claiming that they developed meningioma after using Depo-Provera.
These lawsuits have been consolidated into a multidistrict litigation (MDL) in Florida, where plaintiffs accuse Pfizer and other manufacturers of failing to provide adequate warnings, thus denying women critical information needed for informed reproductive health decisions. They argue that the link between hormone exposure and meningioma risk has been known for years, yet the absence of explicit notices in the U.S. drug label allowed women to proceed with the injection without understanding its potential long-term ramifications.
Despite ongoing litigation, Pfizer has defended itself by pointing to regulatory limits, claiming that previous FDA guidelines did not mandate extended warnings. The company has filed for summary judgment on these grounds, and the outcome of that motion could significantly influence the trajectory of the case.
The human toll behind these legal battles is profound, comprising real stories from women whose lives have been irrevocably altered. Some plaintiffs have had to undergo extensive medical procedures, including surgeries to remove large meningiomas pressing on critical areas of the brain. Others continue to suffer from severe symptoms such as vision loss, headaches, and cognitive issues.
These personal stories have infused a sense of urgency into both media coverage and courtroom discussions, advocating for enhanced drug safety communications from pharmaceutical companies and regulators alike. For many impacted women, the FDA’s recent update provides validation of their experiences and claims, despite its timing.
The clash over Depo-Provera is far from settled, with ongoing lawsuits and significant rulings on the horizon. Should courts dismiss preliminary motions, expert testimony and scientific evidence will likely drive discussions of liability. In the meantime, the updated FDA label compels healthcare providers and patients to reevaluate the balance of risk and benefit in their contraceptive choices.
As the legal battle unfolds, the addition of the brain tumor warning to Depo-Provera’s prescribing information signals a crucial advancement in drug safety discourse. This development has galvanized patients, medical professionals, researchers, and legal advocates to call for greater transparency, improved labeling practices, and accountability from pharmaceutical manufacturers and government regulators alike.