The Food and Drug Administration (FDA) has announced a significant label change for Pfizer’s birth control injection, Depo-Provera. The updated label now includes a warning about the risk of meningioma, a type of tumor affecting the brain’s lining.
FDA Approves Warning About Meningioma Risk
This label revision comes amid ongoing litigation against Pfizer, wherein over 1,000 women allege that the company was aware of the meningioma risk yet did not inform patients. The claims highlight several studies, some dating back to 1983, that suggest a connection between progesterone and meningioma. Plaintiffs argue that these findings imposed a duty on Pfizer to investigate the associated risks sooner.
Depo-Provera Overview
Depo-Provera is a progestin injection administered every three months. It is widely used, with the Centers for Disease Control and Prevention reporting that 25% of sexually active women in the U.S. have used this contraceptive method. Notably, Black women utilize Depo-Provera at nearly double the national average.
Understanding Meningiomas
- Meningiomas are most commonly benign but can be dangerous depending on their size and location.
- Approximately 39,000 meningiomas are diagnosed in the U.S. each year.
- The overall risk of developing a meningioma remains relatively low.
This year, Pfizer sought to have the lawsuit dismissed, stating it learned of the risks associated with Depo-Provera in 2023. In a proactive move, the company submitted a request to the FDA in February 2024 to add the meningioma warning. However, the FDA initially rejected this request, indicating that existing observational studies did not justify such a label change.
Subsequent Developments
Following the denial, Pfizer revised its application and resubmitted it in June 2025. The recent FDA approval allows for the addition of meningioma risk information specifically for two versions of the Depo-Provera injection: Depo-Provera CI and Depo-Subq Provera 104. The FDA confirmed the receipt of the amendment in a letter to Pfizer, acknowledging the approval.
Statements and Global Context
A spokesperson for Pfizer remarked that the updated label is a reflection of the FDA’s recent decision. The statement emphasized the drug’s long-standing safety and efficacy for millions of women managing their reproductive health.
Lawyers representing the women suing Pfizer expressed their satisfaction with the FDA’s label change. They highlighted that Pfizer had misled users about the link between Depo-Provera and meningiomas for years, leading to suffering among countless women.
Internationally, similar warnings regarding meningioma risk have already been implemented. In 2024, both the European Medicines Agency and Canada updated their labeling for high doses of medroxyprogesterone acetate to include meningioma as a possible side effect. South Africa’s drug regulatory agency also recommended a label update in January 2024.
The legal proceedings against Pfizer in the U.S. are still ongoing, and a decision from the judge is pending.
