In the United States, the long-running controversy over the widely used injectable contraceptive Depo-Provera reached a new and significant turning point in December 2025. The U.S. A change to the drug’s label that warns patients and healthcare providers about a possible link between long-term use of the medication and meningioma, a type of brain tumor, was officially approved by the Food and Drug Administration (FDA).
This decision, which has been in the works for a long time, comes amid a rapidly expanding number of lawsuits against the drug’s manufacturer, Pfizer, alleging that the company failed to adequately warn users about serious health risks. For millions of women, the Depo-Provera shot has been a convenient birth control option for decades. Administered every three months, the progestin-based injection has helped prevent pregnancy without the need for daily attention.
But emerging research and an increasingly vocal legal community have challenged long-held assumptions about its safety. Plaintiffs claim the drug’s risks were downplayed or ignored for years, only to become painfully real as more women developed brain tumors long after using the contraceptive.
Until recently, the U.S. label for Depo-Provera focused primarily on well-known side effects like bone density loss and blood clot risks. Meningioma — a tumor that forms in the membranes surrounding the brain and spinal cord — was notably absent from U.S. warnings even though regulators in Europe, Canada, and Australia had already acknowledged such risks on their own labels.
The FDA’s updated label now states that “meningioma cases have been reported with repeated use of Depo-Provera” and urges clinicians to counsel patients who may be at risk. This change reflects growing scientific evidence that long-acting progestin injections may play a role in the development of these tumors, especially after prolonged use. Some studies suggest that women who use Depo-Provera for more than one year have a significantly increased incidence of meningioma compared with women who use other contraceptives.
For advocates, patients, and attorneys involved in the lawsuits, the label change is overdue. It is argued by many that it is an important step toward transparency, but that it does not go far enough to acknowledge how long the risk went unnoticed and the alleged suffering that resulted. More than 1,200 women across the United States have now filed lawsuits claiming they developed meningioma after using Depo-Provera.
These cases — consolidated into a multidistrict litigation (MDL) before a federal judge in Florida — allege that Pfizer and other manufacturers failed to warn users and healthcare providers about the risk, depriving women of the information they needed to make informed decisions about their reproductive health.
Plaintiffs contend that evidence linking hormone exposure and meningioma risk has existed for decades, yet warnings were not updated in a timely manner. They argue that the absence of explicit notice in the drug’s U.S. label allowed women to use Depo-Provera without fully understanding its potential long-term consequences.
These position statements have done little to slow the pace of litigation, even though Pfizer has defended itself by citing regulatory constraints, such as the FDA’s previous refusal to approve broader warnings. In legal filings, Pfizer has argued that federal law preempts many of the state-law claims because the FDA did not require the warning prior to 2025. The company’s motion for summary judgment on these grounds is still pending, and its outcome could shape the future of the entire case.
Behind the legal arguments are deeply personal stories. Women who used to get pregnant with Depo-Provera now have to go through months of medical tests, surgeries, and ongoing care for their brains. Some plaintiffs have undergone operations to remove large meningiomas pressing against critical parts of the brain, while others continue to deal with lasting symptoms such as vision loss, headaches, and memory problems.
These narratives have brought a visceral urgency to the courtroom and media coverage, pressuring both pharmaceutical companies and regulators to address gaps in drug safety communication. For many, the FDA’s recent label change represents a validation of their medical and legal claims — even if it comes later than they think it should have.
The Depo-Provera legal fight is far from over. With lawsuits continuing to mount and key rulings still pending, much remains uncertain. If courts allow the cases to proceed past preliminary motions, expert testimony and scientific studies will likely play central roles in determining liability. Meanwhile, the updated FDA label adds a new dimension to public understanding of the drug’s risks.
Healthcare providers and patients alike are now asked to grapple with a more complex risk-benefit calculation when considering contraceptive options. And for the thousands of women whose lives have been impacted, the legal battle is as much about accountability as it is about warning others.
The FDA’s addition of a brain tumor warning to Depo-Provera’s prescribing information marks a significant milestone in a growing safety and legal controversy — one that has mobilized patients, doctors, researchers, and attorneys to demand greater transparency, better labeling, and accountability from both regulators and drug manufacturers.
