FDA Approves Brain Tumor Warning For Pfizer's Depo-Provera Amid Lawsuit

The U.S. Food and Drug Administration (FDA) has approved a label change for Pfizer Inc.'s (NYSE:PFE) Depo-Provera contraceptive injection, adding a warning about the risk of meningioma, a type of brain tumor, as the company faces mounting legal challenges over the drug's safety disclosures.

The decision affects two injectable versions of the drug — Depo-Provera CI and Depo-Subq Provera 104.

The label update comes as the pharmaceutical giant is defending itself against lawsuits brought by more than 1,000 women who allege the company knew about the potential risk of meningiomas and failed to adequately warn patients.

Depo-Provera is a long-acting contraceptive given as a progestin injection once every three months. The lawsuits cite scientific studies dating back to the early 1980s that suggested a link between progesterone exposure and meningioma development.

Also Read: Pfizer Faces Court Over Depo-Provera Brain Tumor Claims

Plaintiffs argue that those findings created an obligation for Pfizer to investigate the risk earlier, particularly given the drug’s widespread use.

Citing court filings, NBC News highlighted that Pfizer became aware of the potential association between Depo-Provera and meningiomas in 2023. The company submitted a request to the FDA in early 2024 to add a warning to the drug's label. That request was initially denied, with regulators stating that available observational data did not justify a warning for lower-dose products containing medroxyprogesterone acetate.

Pfizer amended and resubmitted its application in June 2025. The FDA approved the revised warning earlier in December.

A Pfizer spokesperson told NBC News that the update reflects the agency's final decision and reiterated that the company stands by the safety and effectiveness of Depo-Provera.

Attorneys representing the plaintiffs welcomed the FDA's move, saying the label change will better inform patients. A U.S. judge has not yet ruled on the pending litigation.

Price Action: PFE stock is down 1.49% at $25.15 at the last check on Wednesday.

Read Next:

• OpenAI Taps Former UK Chancellor George Osborne To Lead Global Government AI Push Amid US-UK Tech Deal Freeze

Image: Shutterstock