The Meals and Drug Administration authorised on Friday a label change for Pfizer’s contraception shot Depo-Provera that warns sufferers of the danger of meningioma, a tumor within the lining of the mind.
Pfizer is at the moment battling a lawsuit during which greater than 1,000 girls declare the corporate knew concerning the danger and didn’t warn sufferers.
The Depo-Provera routine consists of a progestin injection given each three months. The lawsuit factors to a number of research relationship way back to 1983 exhibiting a hyperlink between progesterone and meningioma, saying these research created an “unassignable responsibility to research,” and that Pfizer ought to have studied the dangers related to Depo-Provera sooner. (Progestin is an artificial model of progesterone.)
In keeping with the Facilities for Illness Management and Prevention, 1 in 4 sexually energetic girls in the USA have used Depo-Provera. Black girls use it at practically double the nationwide charge.
Meningiomas are normally not cancerous — that means they don’t unfold to different components of the physique — however they are often dangerous relying on their measurement and the place they develop. The general danger of creating a meningioma stays small: About 39,000 meningiomas are identified annually within the U.S.
In a courtroom submitting this 12 months, Pfizer requested a decide to dismiss the lawsuit, saying it turned conscious of the dangers of meningioma related to Depo-Provera in 2023, and in February 2024 it submitted an utility to the FDA so as to add a warning to the drug’s label. The appliance additionally requested including warnings to 2 drugs containing a lot decrease doses of medroxyprogesterone acetate (MPA), the drug used within the shot.
The FDA denied that request, in keeping with the submitting, saying “the findings of the accessible observational research alone don’t assist the addition of a warning on Meningioma danger to medroxyprogesterone acetate (MPA)-containing merchandise.”
The corporate then amended and resubmitted its utility to the FDA in June 2025.
In response, the FDA this month authorised a change to the label for 2 variations of the injection — Depo-Provera CI and Depo-Subq Provera 104.
“We acknowledge receipt of your modification dated June 12, 2025,” the FDA letter to Pfizer stated. The approval “offers for the addition of data associated to Meningioma danger” on the drug’s label.
In a press release to NBC Information, a Pfizer spokesperson stated the “label replace displays a current determination by the FDA to approve the warning, which the company had earlier denied.”
“Pfizer stands behind the security and efficacy of Depo-Provera, which has been utilized by hundreds of thousands of girls worldwide and stays an essential therapy possibility for girls in search of to handle their reproductive well being,” the assertion stated.
Attorneys for the ladies suing Pfizer stated: “For years, Pfizer misled docs, sufferers and the FDA about Depo-Provera’s hyperlink to meningiomas, ensuing within the useless struggling of 1000’s of girls who developed these harmful mind tumors. … We applaud the FDA in lastly requiring this label change to raised inform and shield girls.”
The FDA didn’t instantly reply to a request for remark.
In different components of the world, a meningioma danger warning has already been added to the drug’s label.
In 2024, the European Medicines Company added meningioma as a “doable aspect impact” of medicine with excessive doses of medroxyprogesterone acetate. That very same 12 months, Canada’s label for the drug was up to date to incorporate meningioma in its “warnings and precautions” part, stating that “meningiomas have been reported following long-term administration of progestins, together with medroxyprogesterone acetate.”
In January, South Africa’s drug regulatory company additionally really helpful updating the drug label for MPA to incorporate meningioma danger.
The decide has but to problem a choice within the case towards Pfizer in the USA.
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