Depo-Provera
OpenACTIVECausation
Studies show prolonged use of medroxyprogesterone acetate (MPA) significantly increases risk of meningioma (benign brain tumor). French ANSM study (2024) found 5.6x increased risk after 3+ years. FDA added meningioma warning to label December 2025, substantially strengthening plaintiffs' position on causation.
Defendants
| Entity | Role | Note |
|---|---|---|
| Pfizer Inc. | Manufacturer | Current manufacturer and label holder |
| Pharmacia & Upjohn | Original Manufacturer | Developed Depo-Provera; acquired by Pfizer |
Litigation Timeline
Intelligence Signals
The Horseracing Integrity and Safety Act of 2020 recognizes a self-regulatory nonprofit organization, the Horseracing Integrity and Safety Authority, which is charged with developing proposed rules on a variety of subjects. Those proposed rules and later proposed rule modifications take effect only if approved by the Federal Trade Commission. The proposed rules and rule modifications must be published in the Federal Register for public comment. Thereafter, the Commission has 60 days from the dat
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 26 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product- specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" tha
The Food and Drug Administration (FDA or Agency) has determined that LUNELLE (estradiol cypionate and medroxyprogesterone acetate) injectable, 5 milligrams (mg)/0.5 milliliter (mL) estradiol cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for estradiol cypionate and medroxyprogesterone acetate injectable, 5 mg/0.5 mL estradiol cypionat
Reuter G, Wandschneider B. JAMA neurology. 2025 Nov 1.
Tettamanti G et al.. Neuro-oncology. 2026 Feb 1.
Reynolds LM, Arend R, Griffin RL. Epidemiologia (Basel, Switzerland). 2025 Sep 29.
Braman BC, Raleigh DR. Neuro-oncology. 2026 Feb 1.
Hudelist B et al.. EClinicalMedicine. 2026 Feb.
Key Facts
- Status
- active
Geographic Exposure
Eligibility Criteria
- ✓Used Depo-Provera for 1+ years
- ✓Diagnosed with meningioma (brain tumor)
- ✓Diagnosis occurred during or after Depo-Provera use
- ✓No prior history of brain tumors before use