Foreign Depo-Provera Labels Include Warnings Not Listed in U.S., Lawsuits Claim
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A labeling inconsistency may become a key point in the growing litigation involving Depo-Provera.
Lawsuits, which are being filed over claims that the contraceptive injection is linked to a higher risk of developing certain tumors, state that warning labels for the drug omit key information in the United States that has been added to labels overseas.
“The U.S. label for Depo-Provera still makes no mention of the increased risk to patients of developing intracranial meningiomas despite the fact that the European Union (EU) and the United Kingdom labels now list meningioma under the “special warnings and precautions for use,” lawsuits filed for plaintiffs Monique Jones and Kathleen Fazio state.
The European labels also advise patients to speak with their doctors before being administered Depo-Provera if they have a history of meningioma.
Lawsuits also claim that the Canadian label for the drug has mentioned meningiomas as a potential “post-market adverse drug reaction” for nearly 10 years, while no such warnings have been included on the U.S. label.
Depo-Provera’s possible ties to meningiomas entered the spotlight in March when a new study was published in the British Medical Journal. Research included in the study suggested that long-term users of Depo-Provera were more than five times more likely to develop a meningioma than the average person.
According to Cleveland Clinic, meningiomas form in the tissue that covers the brain and spinal cord. They are typically benign but can still cause serious health issues and may require surgery to remove.
Why Women Are Filing Depo-Provera Lawsuits
Litigation involving Depo-Provera is still in the early stages, but lawsuits that have been filed claim that the drug’s manufacturers failed to warn customers about the risks of developing a meningioma.
Fazio, who had received regular injections for nearly 20 years, began having memory issues and headaches while also experiencing lethargy and disorientation by 2017. That December, she decided to go to the emergency room after she became disoriented while driving.
According to her lawsuit, an MRI revealed that she had developed a meningioma that caused fluid to accumulate in her brain. She needed a serious surgical procedure to remove the mass.
But Fazio’s issues didn’t end after the surgery, as she experienced vision issues due to complications from the procedure. She continued to receive Depo-Provera shots after the procedure, with a doctor confirming that it was safe to do so.
Jones found herself in a similar situation when she started having headaches, vertigo and blurred vision after 20 years of on-and-off Depo-Provera usage. A CT scan uncovered a meningioma in 2020, but doctors were not comfortable removing it due to the risks involved with its location near the brain and its significant calcification.
Her lawsuit states that this left Jones to live with the symptoms of her tumor, which was regularly monitored by doctors. Jones, who received around 90 Depo-Provera shots over the course of her life, didn’t realize the drug may have been responsible for her condition until the BMJ study was publicized in March.
Pharmaceutical companies such as Pfizer and Viatris are listed as defendants in the lawsuit.
Litigation has begun to ramp up in recent months as awareness spreads about the potential risks for those who have been administered the drug. The BMJ study noted that there were more than 70 million Depo-Provera users worldwide in 2019.
Lawyers continue to accept and investigate new cases for those who may have been impacted.