According to a complaint (PDF) filed by Kristina Schmidt in the Northern District of California on October 1, Pfizer has updated Depo-Provera special warnings and precautions for use label in the European Union (EU) and the United Kingdom to now list meningioma as a possible side effect.
The updated Depo-Prover label also advises EU patients to speak with their doctors before using Depo-Provera if they have any history of meningioma. However, versions of the drug continue to be sold in the United States without any mention of meningioma side effects on the drug label.
The lawsuit claims that Pfizer has failed to take appropriate action in the U.S. market to adequately warn and protect the millions of Americans who are unknowingly using a prescription birth control medication, which could put them at a fivefold increased risk of developing meningioma side effects, as outlined in the March 2024 BMJ study.
Specifically, Schmidt points out that Pfizer has the ability, and responsibility, to promptly update U.S. labels through the “Changes Being Effected” (CBE) process. This provision through the U.S. Food and Drug Administration empowers drug manufacturers to unilaterally alter labels to strengthen safety warnings based on new medical or scientific evidence without prior FDA approval.
Drug manufacturers like Pfizer are expected to continuously monitor the performance and safety of their products through post-market surveillance. This ongoing vigilance helps identify adverse effects that may not have been apparent during pre-market testing. When such effects are identified, manufacturers are not only obliged to report these findings to the FDA but also to take proactive steps to update the drug’s labeling to reflect this new risk information.
However, despite possessing this capability to be transparent with the medical community and millions of Americans, there is no indication that Pfizer has used the CBE process to add warnings about meningioma to the Depo-Provera labels in the U.S., nor have they issued any press release or statements warning U.S. consumers about the Depo-Provera brain tumor risks.
Depo-Provera Lawsuits Being Pursued in the United States
As a result of the drug manufacturer’s apparent failure to adequately research the safety and efficacy of the birth control shot, Depo-Provera lawyers are now investigating claims for women who received the injections and subsequently developed meningioma brain tumors.
To determine whether you or a loved one may be eligible for a Depo-Provera lawsuit settlement, submit information about your potential claim for review by a lawyer to determine whether a settlement or lawsuit payout may be available.
All case evaluations are free and there are no fees or expenses unless a recovery is obtained in your case.