The FDA just approved a significant label change for Pfizer Inc. (PFE)'s Depo-Provera contraceptive injection, and the timing couldn't be more uncomfortable for the pharmaceutical giant. The new warning alerts users to the risk of meningioma, a type of brain tumor, right as Pfizer faces more than 1,000 lawsuits from women claiming the company has known about this risk for decades.
The label update applies to both injectable versions of the drug: Depo-Provera CI and Depo-Subq Provera 104. If you're not familiar, Depo-Provera is a long-acting contraceptive that works through a progestin injection administered once every three months. It's been widely used for years, which is precisely why the lawsuits are so sprawling.
The Legal Storm
Here's where things get interesting. The women suing Pfizer aren't just saying the drug caused harm. They're arguing that scientific studies dating back to the early 1980s suggested a link between progesterone exposure and meningioma development, and that these findings should have triggered earlier investigation from Pfizer, especially given how many people were using the drug.
According to court filings reported by NBC News, Pfizer became aware of the potential connection between Depo-Provera and meningiomas in 2023. The company then requested a label change from the FDA in early 2024. Plot twist: the FDA initially said no. Regulators determined that the available observational data didn't justify adding a warning for lower-dose products containing medroxyprogesterone acetate.
Pfizer didn't give up. The company amended and resubmitted its application in June 2025, and this time the FDA approved the revised warning in December.
What Pfizer Says
A Pfizer spokesperson told NBC News that the update reflects the agency's final decision and emphasized that the company continues to stand by the safety and effectiveness of Depo-Provera. Meanwhile, attorneys representing the plaintiffs are calling the label change a win, saying it will better inform patients about potential risks. A U.S. judge hasn't yet ruled on the pending litigation, so this story is far from over.
Price Action: PFE stock is down 1.49% at $25.15 at the last check on Wednesday.
