Depo-Provera, widely used as a female contraceptive injection for over three decades, has now been linked to a significantly increased risk of developing meningiomas, a type of brain tumor, according to a groundbreaking scientific study published in the British Medical Journal. This discovery has sparked the potential for a mass tort, as numerous women who developed brain tumors after prolonged use of the drug are now pursuing legal action against Pfizer.
What is Depo-Provera?
Depo-Provera is Pfizer’s brand name for a contraceptive injection that contains progestin, a synthetic version of the hormone progestogen. Injected into the arm or buttocks every three months, Depo-Provera works by impacting ovulation and thickening the cervical mucus to prevent sperm from successfully getting to an egg.
What is the Depo-Provera lawsuit?
The ongoing lawsuits allege that Pfizer, the manufacturer of Depo-Provera, failed to warn women about the risk of developing intracranial meningiomas if the drug is used for more than a year. FDA data suggests there could be a significant number of potential plaintiffs given the extensive use of Depo-Provera.
Who is the defendant in the Depo-Provera lawsuit?
The defendant in the lawsuit is Pfizer. Depo-Provera was approved by the US Food and Drug administration in October 1992 for contraceptive use, although it has been available in the US since 1960 for noncontraceptive purposes. One reason Depo-Provera was not initially approved by the FDA was the evidence of the link between the drug and breast tumors and cervical cancer in animals revealed through clinical studies.
What injuries have been linked to Depo-Provera?
In March 2024, the British Medical Journal released a study that found women who were given medroxyprogesterone acetate, the active ingredient in Depo-Provera, had up to a 5.6 times greater risk for developing meningioma, a type of brain tumor. Meningiomas may typically be noncancerous and slow growing, but they often require surgery for removal. Their proximity to critical brain structures can make intervention risky, and in some cases, inoperable. A tumor that grows can lead to further acute and chronic complications by pressing on the brain or spinal cord, causing headaches, seizures, dizziness and vision problems.
What are the latest updates on the Depo-Provera lawsuit?
October 2024: First Depo-Provera Pfizer Lawsuit Filed
At the beginning of October, the first lawsuit was filed against Pfizer as well as several affiliated companies that sell the authorized generic form of the drug. The plaintiff, Kristina Schmidt, took about 64 injections of Depo-Provera or its generic equivalent between 2005 and 2021. In 2022, after suffering from severe headaches, dizziness, and vertigo, she was diagnosed with a brain tumor at the age of 37. This suit was filed in the U.S. District Court for the northern District of California.
April 2024: Pfizer Releases Statement Following Increased Brain Tumor Risk
Following the publication of the study in the British Medical Journal linking the prolonged use of Depo-Provera with an increased risk of developing brain tumors, Pfizer released a public statement: “We are aware of this potential risk associated with long-term use of progestogens and, in collaboration with regulatory agencies, are in the process of updating product labels and patient information leaflets with appropriate wording.”
As of October 2024, Pfizer has yet to make the promised changes to the warning label for its drug in the United States. However, the company did update the Depo-Provera warning information for patients in Europe.
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