Depo-Provera Brain Tumor Warnings Added to Drug Label in Europe, But Not In U.S.

Recently filed lawsuit questions why Pfizer updated Depo-Provera warning label in Europe about the meningioma brain tumor side effects, but has failed to provide same warnings to U.S. consumers and doctors.

After a groundbreaking study published earlier this year found that side effects of Depo-Provera birth control shots increase the risk of meningioma brain tumors, Pfizer updated the Depo-Provera warning label in Europe. However, a recently filed lawsuit questions why the same information has not been provided in the U.S.

Depo-Provera has been a popular form of birth control for decades, involving a quarterly injection that delivers medroxyprogesterone acetate, a synthetic version of the hormone progesterone. This helps prevent pregnancy by suppressing ovulation, thickening cervical mucus to hinder sperm movement, and thinning the uterine lining to prevent implantation of a fertilized egg.

While the birth control shot has been widely believed to be safe, with few serious health risks, a study published earlier this year in the medical journal The BMJ identified potential Depo-Provera brain tumor side effects, finding that women receiving the birth control shot for one year or longer faced a 5.5 increased risk of developing meningiomas, which can be life-threatening and often require surgical removal.

Despite the serious risks highlighted in the study, most consumers remain unaware that meningioma brain tumors may be caused by Depo-Provera, since the warning label information provided by Pfizer has failed to contain any information about the risk. However, a recently filed Depo-Provera lawsuit brought by a U.S. consumer diagnosed with meningioma raises questions about why Pfizer has recently updated the Depo-Provera warning label in the European Union and United Kingdom, but has failed to take the same steps to warn users in the United States.

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.