FDA Adds Brain Tumor Warning to Depo-Provera Drug Label as Lawsuits Rise
The Food & Drug Administration is now officially warning Depo-Provera users of a potential brain tumor risk tied to use of the popular birth control shot.
This month, the agency updated the drug’s warning label to include information on meningioma, a type of tumor that forms in the lining surrounding the brain. The label update comes as nearly 400 additional Depo-Provera lawsuits have been filed in federal court.
“The FDA’s decision to require a meningioma warning on Depo-Provera’s label provides plaintiffs with strong support for their claim that Pfizer did not share important safety information with regulators and the public,” said Whitney Ray Di Bona, attorney and consumer safety advocate at Drugwatch.
Meningiomas are often benign but can still cause severe health effects and may require invasive surgery to remove.
“Cases of meningiomas have been reported following repeated administration of medroxyprogesterone acetate, primarily with long term use,” the label now states. “Monitor patients on Depo-Provera CI for signs and symptoms of meningioma.”
Depo-Provera, which is made by Pfizer, has been the subject of scrutiny and litigation in recent years over concerns that its use could heighten the risk of developing a meningioma.
A study published in the BMJ in 2024 found that women who took the Depo shot could have a 5.6-fold higher risk of developing this type of tumor.
As of this week, more than 1,800 Depo-Provera lawsuits were active in federal court over claims that Pfizer failed to warn its customers of a possible tumor risk connected to its product. Hundreds of other women have cases pending in various state courts as well.
Label Update Had Been Key Subject in Depo-Provera Lawsuits
The absence of a meningioma warning on the FDA-approved Depo-Provera label had been a key point of debate for the thousands of active Depo lawsuits.
The new label update could have a major impact on the direction of these cases.
Pfizer had previously argued that these lawsuits are federally preempted, or overruled, by a previous FDA decision to not update Depo’s label.
The pharmaceutical giant claimed that, after becoming aware of new research linking Depo-Provera to a tumor risk, it submitted a label update to the FDA that would have alerted customers to that concern.
The FDA, however, rejected that update upon determining that there was not enough evidence to justify the change. Pfizer believed that it should then not be blamed for failing to warn patients who went on to develop meningiomas.
Lawyers representing people who have filed lawsuits see the situation differently.
They say that Pfizer refused to study the potential threat of meningiomas or warn its customers of any risk for decades, even as more evidence amassed. They also claim that the label update in question was so broad — applying to a whole class of drugs — that the agency had no choice but to reject it.
Pfizer went on to submit a new update to the FDA this past June, which has now been approved and added to the Depo-Provera label.
The judge overseeing the Depo lawsuits had previously said that she would not weigh in on Pfizer’s motion to dismiss cases on federal preemption until after the FDA had made a labeling decision.
The company may struggle to maintain that legal stance now that Depo-Provera users have been warned of a meningioma connection.
“If there is proof that Pfizer had this data and chose not to issue a strong warning until now, plaintiffs can argue that the company not only failed to share known risks initially but also ignored its opportunity to protect public health on its own,” Di Bona said.
