Exploring The Dangers of Pfizer’s Depo-Provera Birth Control
Depo-Provera is a long-acting hormonal contraceptive, which is taken once every three months. It has medroxyprogesterone acetate, which is a synthetic progesterone and discourages ovulation, preventing pregnancy. The injection has been in common use since the United States approval in the early 1990s because of its convenience and effectiveness, particularly with women who are trying to avoid using daily contraceptives.
FDA Warning Alert Behind the Label Update: Rise of New Brain Tumor Concerns
In December 2025, the U.S. Food and Drug Administration (FDA) made a significant safety modification to the labeling of Depo-Provera a well-known injectable birth control produced by Pfizer. The organization declared a new warning stating a higher risk of meningioma, which is a form of brain tumor and hormone sensitive. In a 2024 study found that long-term use of progestin-based contraceptives, particularly Depo-Provera, increases the risk of developing these tumors[1]. As a result, the FDA has revised the drug’s warning label for users. This decision comes after the emergence of additional scientific evidence after a significant number of lawsuits from women came in light who revealed they were not adequately informed about the risks associated with using Depo-Provera. In the lawsuits they claimed they were not aware of such reports about the potential danger of developing a brain tumor.
Symptoms of Brain Tumor Risk
Meningioma is a tumor arising in the protective layers of the brain and spinal cord, potentially causing significant issues like:
- Headaches.
- Vision Loss.
- Seizures.
- Neurological Deficits (may necessitate surgical or radiative intervention).
The Mass Tort Litigation Wave: Lawsuits Update
The FDA’s actions have spurred significant litigation against Pfizer, with over 1,470 women alleging that Depo-Provera caused brain tumors due to the lack of adequate warnings from the company[1]. These lawsuits have been consolidated into multidistrict litigation (MDL) considering their volume. Plaintiffs also claimed Pfizer was aware of the risks long before, as similar warnings were mandated in Europe.
Although Pfizer maintains that Depo-Provera is safe when used correctly and argues it was not in a legal position to issue warnings pre-emptively[2]. The outcome of this litigation could significantly impact pharmaceutical regulation and patient safety, urging women to consult with their healthcare providers about the associated risks and stay informed on the ongoing legal issues. This case may influence future risk disclosures for hormonal medications.
Sources:
Drugs.com.“FDA Adds Brain Tumor Warning to Depo-Provera Birth Control Shot.” Drugs.com, 2025.
NIB Direct. “1,470 Women Sue Pfizer over Depo-Provera Brain Tumors as FDA Issues Warning.” NIB Direct, 2025.
Reuters. “Pfizer Faces Growing Litigation over Depo-Provera Warnings.” Reuters, December 14, 2025.
Sokolove Law. “FDA Adds Brain Tumors to Depo-Provera Warning.” Sokolove Law Blog, 2025.
