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Dec 17, 2025 12:00 PM

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 ...