Overview
- On Dec. 13, the FDA approved adding information on meningioma risk to the labels for Depo‑Provera CI and Depo‑SubQ Provera 104.
- The agency had rejected a 2024 warning request based on observational data, then approved an amended submission resubmitted in June 2025; regulators in Europe, Canada and South Africa issued similar warnings in 2024.
- Plaintiffs cite studies dating to the 1980s suggesting a progestin–meningioma link, while Pfizer says it identified a potential risk in 2023 and maintains the product’s safety and effectiveness.
- More than 1,000 women are suing the company over alleged failure to warn, and a U.S. judge has not yet ruled on pending motions, including Pfizer’s bid to dismiss.
- Depo‑Provera is widely used in the U.S., with about one in four sexually active women having received it and higher usage among Black women, and roughly 39,000 meningiomas are diagnosed annually.