Archive · 18 Dec 2025
FDA Adds Brain Tumor Warning to Depo-Provera Label
The FDA has updated the label for Depo-Provera, a birth control shot used by many women, to include a warning about a type of brain tumor called meningioma.
This change comes after many years of studies and lawsuits claiming that Pfizer, the company that makes Depo-Provera, knew about this risk but did not tell users.
The shot is given every three months and is used by about 1 in 4 sexually active women in the US, with Black women using it at nearly double the rate.
Over 1,000 people have sued Pfizer, saying the company should have investigated and disclosed the risk earlier.
The FDA initially rejected Pfizer's application for the label change but later approved it for two versions of the drug.
FDA approved a label change for Depo-Provera to include a meningioma warning.
Depo-Provera is a progestin shot used by 1 in 4 US women, with higher usage among Black women.
Over 1,000 lawsuits allege Pfizer knew about the meningioma risk since 1983 but did not disclose it.
The FDA initially rejected Pfizer's 2024 application but later approved the label change for two versions of the drug.
The controversy escalated due to studies and lawsuits alleging Pfizer's failure to investigate the risks.
- Who
- Pfizer and users of Depo-Provera
- What
- FDA label change for Depo-Provera to include meningioma warning
- When
- 2024
- Where
- United States
- Why
- Due to studies and lawsuits alleging Pfizer knew of the risk since 1983
- Drug
- Depo-Provera
- Manufacturer
- Pfizer
- Warning
- Meningioma risk
- Usage
- Every three months
- User Demographics
- 1 in 4 US women, higher among Black women
- Lawsuits
- Over 1,000 plaintiffs
- FDA Action
- Label change approved in 2024