The FDA approved a label change for Pfizer’s birth control injection Depo-Provera on Dec. 13, adding a warning about the risk of meningioma — a brain tumor — to two versions of the drug.
The update applies to Depo-Provera CI and Depo-subq Provera 104, NBC News reported Dec. 16. In June, Pfizer submitted an amended application to the FDA to add a warning to the drug’s label after the agency rejected an initial request in 2024.
More than 1,000 women are suing Pfizer, alleging the drugmaker failed to warn patients of the potential risk. The lawsuit cites studies dating back to the 1980s linking progesterone to meningioma, according to the report.
One in four sexually active U.S. women have used Depo-Provera, according to CDC data cited by NBC, and usage among Black women is nearly twice the national average. About 39,000 meningiomas are diagnosed in the U.S. each year.
Health regulators in Europe, Canada and South Africa added similar warnings to the drug’s label in 2024. A U.S. judge has not yet ruled on Pfizer’s motion to dismiss the case.
