Foreign Depo-Provera Labels Warn of Tumor Risks Absent from U.S. Guidelines

Lawsuits Target Pharmaceutical Companies Over Missing Brain Tumor Warnings

Two women have filed lawsuits against Pfizer and Viatris over Depo-Provera’s undisclosed brain tumor risks in U.S. warning labels. A March 2024 British Medical Journal study found long-term users of the contraceptive injection are five times more likely to develop meningiomas than non-users. The lawsuits, filed by Monique Jones and Kathleen Fazio, point to European Union, United Kingdom, and Canadian labels that have included meningioma warnings for nearly a decade. Both women developed meningiomas after about 20 years of Depo-Provera injections, discovered in 2020 and 2017 respectively.

5 Key Points

• The British Medical Journal study identified over 70 million Depo-Provera users worldwide as of 2019.
• Warning labels in the European Union and the United Kingdom list meningioma under “special warnings and precautions for use”.
• Canadian Depo-Provera labels have listed meningioma as a “post-market adverse drug reaction” since 2014.
• Plaintiff Kathleen Fazio underwent brain surgery to remove her meningioma after severe disorientation.
• Plaintiff Monique Jones manages an inoperable tumor with ongoing medical monitoring.

U.S. Labels Omit Warnings Present Overseas Since 2014

The U.S. Depo-Provera label excludes brain tumor warnings that appear on the same drug’s packaging in multiple other countries. “The U.S. label for Depo-Provera still makes no mention of the increased risk to patients of developing intracranial meningiomas even though the European Union and the United Kingdom labels now list meningioma under the special warnings and precautions for use,” according to the Jones and Fazio lawsuits. Canadian health authorities added meningioma warnings to Depo-Provera labels in 2014.

Brain Surgery Required After Two Decades of Injections

After nearly 20 years of regular Depo-Provera use, Kathleen Fazio drove herself to the emergency room in December 2017 while experiencing severe disorientation. An MRI revealed a meningioma causing brain fluid buildup, requiring immediate surgery. The procedure left Fazio with ongoing vision problems. Her doctors later cleared her to continue Depo-Provera injections, stating they were safe.

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Inoperable Tumor Forces Ongoing Medical Monitoring

Monique Jones received approximately 90 Depo-Provera injections over 20 years before developing headaches, vertigo, and blurred vision. A 2020 CT scan located a meningioma, but doctors determined surgery was too dangerous due to the tumor’s location near critical brain areas and its calcification. Jones continues regular medical monitoring of her tumor. She only learned of the potential link to Depo-Provera after the publication of the March 2024 study.

March 2024 Study Shows Five-fold Tumor Risk

The British Medical Journal study analyzed Depo-Provera’s effects on more than 70 million users worldwide. The research revealed that long-term users develop meningiomas at five times the rate of non-users. According to the Cleveland Clinic, these tumors form in the tissue covering the brain and spinal cord. While usually non-cancerous, meningiomas can require surgery and cause serious complications.