With more than 1 800 lawsuits linked to Pfizer’s Depo-Provera contraceptive drug, the US Food & Drug Administration is now officially warning users of a potential brain tumour risk tied to use of the popular birth control shot.
Drugwatch reports that the agency recently updated the drug’s warning label to include information on meningioma, a type of tumour 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 the 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.”
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 tumour.
The absence of a meningioma warning on the 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 pre-empted, 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 tumour risk, it submitted a label update to the FDA that would have alerted customers to that concern.
The FDA, however, rejected that update after 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 submitted a new update to the FDA last 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 pre-emption until after the FDA had made a labelling 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.
See more from MedicalBrief archives:
Pfizer’s birth control injection blamed for woman’s brain tumours
Birth control jab linked to higher brain tumour risks – large US analysis