December 2025 — Washington, D.C. — In a significant update affecting millions of women, the U.S. Food and Drug Administration (FDA) has approved a new safety warning for the widely prescribed injectable contraceptive Depo-Provera, alerting users and healthcare providers to a possible link between the birth control shot and meningioma brain tumors.
The FDA’s recent decision requires updated labeling on two formulations of the product, Depo-Provera CI and Depo-SubQ Provera 104, to include language about the risk of meningioma, a typically slow-growing tumor that arises from the membranes surrounding the brain and spinal cord.
What the New Labeling Means
The labeling change is intended to:
- Provide clearer information to patients and clinicians about the possible association between Depo-Provera and meningioma risk.
- Ensure that individuals considering or currently using the contraceptive are aware of known safety data.
- Aid healthcare professionals in counseling patients on the benefits and risks of long-acting injectable contraception.
Depo-Provera, which contains the synthetic hormone medroxyprogesterone acetate (MPA) and is administered every three months, has been a staple contraceptive option in the United States for decades, with an estimated one in four sexually active women having used the shot at some point. Usage rates are particularly high among certain populations, including Black women.
Understanding Meningioma Risk
Meningiomas are generally benign tumors, but depending on their size and location, they can lead to significant neurological effects — including headaches, vision issues, balance problems, and other symptoms that may require invasive surgery or prolonged medical care.
Decades of scientific studies have shown an association between medroxyprogesterone acetate and these tumors. Regulatory agencies in Europe, Canada, and South Africa already require similar warnings on related products.
What Women Should Know
Healthcare providers are encouraged to review the updated labeling and discuss it with patients who use or are considering Depo-Provera, especially for long-term contraception. Women who have used the product and are experiencing unusual neurological symptoms, such as persistent headaches, vision changes, or dizziness, should consult a medical professional promptly.
Looking Ahead
This FDA label change represents a notable shift in how potential risks associated with hormonal contraceptives are communicated in the U.S. It underscores the importance of ongoing safety monitoring and transparent risk communication to support patient health and informed decision-making.
Stay tuned to our blog for updates on clinical guidance, research developments, and implications for women’s health policy as this story evolves.
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