
Both Penner and Vanden Heuvel are working hard on creating awareness of brain tumor risk. They particularly want to get the word out to women you have been on Depo for more than a few years. And the longer you take it, the more likely it is that you would develop a brain tumor.
Failure to Warn
“The problem with this drug is that the manufacturers haven’t changed the warning label or informed doctors,” adds Penner. So, most people will learn of the risks online, through legal claim advertisements, radio and TV ads—for now. Despite knowing that meningiomas often require surgical removal due to the pressure they can put on the brain, Pfizer has not updated its warning labels for the birth control shot. But European and Canadian labels now include a warning about the associated risks, which begs the question: what is the FDA doing, and why hasn’t it slapped a black-box warning on Depo-Provera, like it warned with bone mineral density loss?
Here is an AI answer:
“The FDA has currently not added a "black box" warning specifically for brain tumors on Depo-Provera because while recent studies indicate a potential link between long-term use of the drug and an increased risk of developing meningiomas (a type of brain tumor), the evidence is still considered emerging and not conclusive enough for such a strong warning label; however, the FDA does have existing warnings on Depo-Provera regarding bone density loss and other potential side effects, and is likely monitoring ongoing research on the brain tumor connection closely.”
Surely Pfizer is familiar with studies since 2023 associating its drug with meningiomas. Two studies released findings that linked the use of progestogen to increased chances of developing brain tumors and meningioma. The BMJ published a study in early 2024 from researchers in France that sought to “assess the risk of intracranial meningioma associated with the use of selected progestogens” over a ten-year period using a national case-control study. And the Journal of Neurological Surgery published a study in 2023 that followed ten patients between 2014 and 2021 who were treated at the University of Pittsburgh Medical Center. It found that discontinuation of MPA use (the progestin subtype found in Depo-Provera) had “clear evidence” of meningioma shrinkage, leading the researchers to conclude that there is a “clear progestin meningioma syndrome associated with chronic MPA use,” according to one Dep-Provera lawsuit recently filed.
Although the researchers noted that the association between chronic progestin use and meningioma patients has been studied in Europe, the association had not been examined in the U.S., particularly regarding the progestin subtype MPA (Depo-Provera). Those ten patients were instructed to stop using MPA, and afterwards, five of the patients had “clear evidence” of meningioma shrinkage, leading the scientists to conclude that there is a “clear progestin meningioma syndrome associated with chronic DMPA use”.
READ MORE DEPO PROVERA LEGAL NEWS
“Our goal is that Pfizer change its corporate practices for the better,” says Penner. “They have changed the label in the EU referring to meningioma risk and identified the link with meningioma growth. At the end of the day, patients [in the U.S.] need to be informed of risk so they can make informed decisions about their health.”