In December 2025, the U.S. Food and Drug Administration (FDA) approved a label update for the long-acting injectable contraceptive depot medroxyprogesterone acetate, commonly known as Depo-Provera. The updated label warns of a potential increased risk of meningioma, a type of tumor affecting the protective lining of the brain. This update reflects emerging scientific evidence and underscores the importance of informed, individualized decision-making when considering long-term hormonal therapies. What Is a Meningioma? A meningioma is a tumor that develops in the meninges, the membranes surrounding the brain and spinal cord. While many meningiomas are benign, they can still cause symptoms such as headaches, vision changes, seizures, or cognitive effects depending on size and location. From a longevity and brain-health perspective, even benign tumors are clinically relevant due to their potential impact on neurological function and quality of life over time. What Does the Research Show? The FDA’s label change was prompted by findings from large population-based studies evaluating hormonal contraceptive exposure: Although these studies are observational and do not establish causation, the consistency of findings across large datasets led regulators to update product labeling. Which Depo-Provera Products Are Affected? The updated FDA warning applies to both formulations manufactured by Pfizer: An Integrative and Longevity-Focused Perspective At Bionuu, we view hormone therapies through a systems-based lens. Hormones influence not only reproductive health, but also: This FDA update highlights a key integrative principle: the timing, duration, and cumulative exposure to hormones matter. While Depo-Provera remains an effective option for some individuals, long-term use—particularly later in reproductive life—should be periodically reassessed. …
In December 2025, the U.S. Food and Drug Administration (FDA) approved a label update for the long-acting injectable contraceptive depot medroxyprogesterone acetate, commonly known as Depo-Provera. The updated label warns of a potential increased risk of meningioma, a type of tumor affecting the protective lining of the brain.
This update reflects emerging scientific evidence and underscores the importance of informed, individualized decision-making when considering long-term hormonal therapies.
What Is a Meningioma?
A meningioma is a tumor that develops in the meninges, the membranes surrounding the brain and spinal cord. While many meningiomas are benign, they can still cause symptoms such as headaches, vision changes, seizures, or cognitive effects depending on size and location.
From a longevity and brain-health perspective, even benign tumors are clinically relevant due to their potential impact on neurological function and quality of life over time.
What Does the Research Show?
The FDA’s label change was prompted by findings from large population-based studies evaluating hormonal contraceptive exposure:
- A study published in The BMJ reported a fivefold increased risk of meningioma among users of Depo-Provera.
- A separate study published in JAMA Neurology found a twofold increased risk, with the greatest risk observed in women who:
- Initiated Depo-Provera use after age 31
- Used the injection for four years or longer
Although these studies are observational and do not establish causation, the consistency of findings across large datasets led regulators to update product labeling.
Which Depo-Provera Products Are Affected?
The updated FDA warning applies to both formulations manufactured by Pfizer:
- Depo-Provera CI (intramuscular injection)
- Depo-SubQ Provera 104 (subcutaneous injection)
An Integrative and Longevity-Focused Perspective
At Bionuu, we view hormone therapies through a systems-based lens. Hormones influence not only reproductive health, but also:
- Brain and cognitive function
- Vascular and metabolic health
- Inflammatory signaling
- Bone density and musculoskeletal aging
This FDA update highlights a key integrative principle: the timing, duration, and cumulative exposure to hormones matter. While Depo-Provera remains an effective option for some individuals, long-term use—particularly later in reproductive life—should be periodically reassessed.
What Patients Should Consider
If you are currently using Depo-Provera or considering it, a personalized discussion with your healthcare provider may include:
- Duration of past or planned use
- Age at initiation
- New or persistent neurologic symptoms (e.g., headaches, vision changes)
- Personal or family history of meningioma
- Alternative contraceptive options aligned with long-term health goals
Thoughtful Care for Long-Term Health
FDA label updates like this one are not intended to create alarm, but to support transparent, evidence-informed care. As research evolves, so should the conversations around commonly used therapies.
At Bionuu, we prioritize shared decision-making that balances effectiveness, safety, and long-term wellbeing. If you have questions about hormonal contraception, brain health, or longevity-focused care, our team is here to help guide those discussions.
Ready to start your journey to better health?
