What is the new warning for Pfizer's Depo-Provera birth control?

The FDA has mandated a label change for Depo-Provera to warn patients about the risk of meningioma, a type of brain tumor.

Why are women suing Pfizer over Depo-Provera?

Women are suing Pfizer alleging the company knew about the meningioma risk associated with Depo-Provera and failed to warn patients.

Have other countries warned about meningioma risk with Depo-Provera?

Yes, regulatory agencies in Europe, Canada, and South Africa have already updated drug labels to include meningioma risk warnings.

Home / Health / FDA Mandates Warning for Pfizer Birth Control

FDA Mandates Warning for Pfizer Birth Control

17 Dec

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Summary

FDA approves label change for Pfizer's Depo-Provera birth control.
Lawsuit claims Pfizer knew about meningioma risk and failed to warn.
International agencies in Europe, Canada, and South Africa issued warnings.

FDA Mandates Warning for Pfizer Birth Control

The U.S. Food and Drug Administration has approved a significant label update for Pfizer's Depo-Provera birth control injection, now explicitly warning patients about the risk of meningioma, a tumor affecting the brain's lining. This regulatory action comes amidst ongoing legal battles, with over 1,000 women suing Pfizer. They allege the pharmaceutical giant was aware of the potential tumor risk associated with the drug and deliberately failed to inform patients.

Legal filings by the plaintiffs cite studies dating back to 1983 that indicated a link between progesterone and meningiomas, suggesting Pfizer had a duty to investigate these risks sooner. Meanwhile, Pfizer has sought to dismiss the lawsuit, asserting they only became aware of the risks in 2023 and promptly applied for the FDA warning. However, the FDA initially denied a warning request for related pill formulations.