WESTWEGO, Louisiana — Robin Phillip’s contemporary haircut is dyed her favourite colour — inexperienced. However beneath the dye job is a scar that runs alongside the aspect of her head, the results of two craniotomies.
For years, Phillip, 45, suffered from what she thought have been migraines. It wasn’t till early 2018, when she needed to go away her warehouse shift to drive to the hospital, that she realized her complications have been a symptom of one thing extra critical. She mentioned she almost crashed on the drive to the emergency room, blinded by ache.
“The nurse mentioned, ‘OK, what’s your ache from 1 to 10?’ I mentioned 11, 12,” mentioned Phillip. “They put me within the chair, and I don’t bear in mind nothing after that.”
Phillip awoke later to surprising information: She had an intracranial meningioma — a tumor of the liner of the mind. She wanted emergency surgical procedure.
After the process, Phillip misplaced imaginative and prescient in her left eye and needed to re-learn how you can stroll. Unable to work, she misplaced her condo and moved in along with her mom till she may get again on her toes.
“I used to be feeling misplaced, as a result of the place would I’ve probably gotten a tumor from? I had a daily life. I did common issues,” she mentioned. “What may have probably prompted this to occur to me?”
At the moment, Phillip believes her contraception is guilty. For almost 30 years, stopping solely when she had her two kids, she used Depo-Provera — a progestin shot given 3 times a 12 months. She’s one in all greater than 1,000 girls suing Pfizer, which makes the drug, alleging the corporate knew extra concerning the dangers and did not warn customers. Pfizer has moved to have the swimsuit dismissed, arguing the case is pre-empted by a Meals and Drug Administration determination, and says it stands behind the security and efficacy of Depo-Provera.
In response to the Facilities for Illness Management and Prevention, 1 in 4 sexually energetic girls in america have used Depo-Provera. Black girls use it at almost double the nationwide fee.
Meningiomas are often not cancerous — which means they don’t unfold to different elements of the physique — however they are often dangerous relying on their measurement and the place they develop.
Phillip’s tumor was urgent on her optic nerve, inflicting imaginative and prescient issues.
Current analysis
Lately, a number of research have proven a attainable hyperlink between Depo-Provera use and an elevated danger of growing meningioma.
One among them, printed earlier this month in JAMA Neurology, linked medroxyprogesterone acetate (MPA), the drug in Depo-Provera, with a twofold improve in danger for meningioma. The danger was biggest in girls who used the contraceptive for greater than 4 years or began after age 31.
One other one, a 2024 examine printed within the The BMJ based mostly on French information, discovered a fivefold improve in danger for meningioma for long-term Depo-Provera customers.
Docs warning that the research are observational, which means they can not show the treatment prompted the tumors.
Dr. David Raleigh, a radiation oncologist who makes a speciality of mind tumors and who’s the chair of meningioma analysis on the College of California San Francisco’s Division of Radiation Oncology, mentioned that feminine intercourse hormones — progesterone particularly — are linked to meningioma. (Progestin, the hormone in Depo-Provera, is an artificial model of progesterone.) Meningiomas are the one mind tumors which might be extra frequent in girls than in males, he added.
Nonetheless, Raleigh mentioned this doesn’t essentially imply that progesterone is inflicting a meningioma to kind. “All of the out there information counsel that progesterone is gas on the hearth,” he mentioned. “Progesterone didn’t essentially begin the hearth, however the out there information counsel that it’s like dumping fuel on it.”
He mentioned that the latest research linking Depo-Provera to meningioma give him pause.
“These of us within the enterprise typically advocate that sufferers with meningioma keep away from hormone alternative remedy, use nonhormone based mostly technique of contraception, if attainable, and to be cautious with being pregnant and fertility planning due to these very properly documented associations,” he mentioned. “These new research solely amplify these considerations and issues.”
The general danger of growing meningioma stays small: About 39,000 meningiomas are identified every year within the U.S.
“Total, meningioma is just not frequent. This isn’t a sort of tumor that we see fairly often,” mentioned Dr. Colleen Denny, an OB-GYN at NYU Langone Well being. “The probability of getting a meningioma as a Depo consumer is extremely low. It’s simply that it’s extremely, extremely low for individuals who don’t use Depo.”
The American Faculty of Obstetricians and Gynecologists (ACOG) printed a response to The BMJ examine urging warning, saying that, “in line with the examine, 5 out of 10,000 girls utilizing medroxyprogesterone acetate could probably develop meningioma in comparison with one out of 10,000 girls not utilizing the treatment.”
“The danger that they’re discovering is extremely small,” mentioned Dr. Nisha Verma, senior adviser for reproductive well being coverage for advocacy at ACOG. “I feel it’s a consideration we are able to speak to sufferers about, amongst the entire issues that sufferers undergo.”
“Uterine most cancers is much more frequent than meningioma, and Depo reduces your danger of uterine most cancers. So how do you steadiness that?” Denny mentioned. “It’s complicated, and it typically will depend on the person sufferers.”
Phillip says even that small danger would have been an excessive amount of for her.
“If I’d have [known] from the get-go, I’d have by no means took that shot,” she mentioned.
The lawsuit
Phillip is now one in all greater than 1,000 girls suing Pfizer, the maker of Depo-Provera, alleging that the corporate did not warn them concerning the danger.
“These girls all have meningiomas. Many have surgical procedure, some have radiation, they usually’ve all had their lives enormously impacted,” mentioned Ellen Relkin, a lawyer representing Phillip and a number of the different plaintiffs.
Phillip’s lawsuit factors to a number of research relationship way back to 1983 exhibiting a hyperlink between progesterone and meningioma. The lawsuit says these research created an “unassignable obligation to research,” and that Pfizer ought to have studied the dangers related to Depo-Provera sooner.
“Defendants willfully, wantonly, and deliberately conspired, and acted in live performance, to disregard related security considerations and to intentionally not examine the long-term security and efficacy of Depo-Provera, notably in persistent long-term customers of Depo-Provera,” the grievance says.
Verma, of ACOG, mentioned that hormonal contraception is well-studied earlier than it hits the market.
“Contraception strategies which might be commercially out there have been studied extensively earlier than changing into out there to the general public, and so we’ve studied each sort of contraception. We’ve checked out security measures,” she mentioned. “We have now tips that do intensive evaluations of the entire information and assist us help sufferers in what strategies could also be safer for them.”
In an announcement to NBC Information, Pfizer mentioned it stands behind the “security and efficacy of Depo-Provera.”
In a court docket submitting earlier this month, the corporate requested a decide to dismiss the case, saying that it grew to become conscious of the dangers of meningioma related to Depo-Provera in 2023, and submitted an utility to the Meals and Drug Administration so as to add a warning to the drug’s label. The applying additionally requested including warnings to 2 drugs containing a lot decrease doses of MPA.
The FDA denied that request, in line with the submitting.
The FDA declined NBC Information’ request for remark, however in its denial letter to Pfizer, which is included in firm’s submitting, it mentioned: “The findings of the out there observational research alone don’t help the addition of a warning on Meningioma danger to medroxyprogesterone acetate (MPA)-containing merchandise.”
A spokesperson for Pfizer advised NBC Information that due to the FDA’s denial, federal regulation pre-empts the corporate from altering the warning label on Depo-Provera.
In an interview with NBC Information, Phillips’ lawyer Relkin mentioned Pfizer had sufficient info to review the attainable dangers related to Depo-Provera by itself earlier than 2023 and accused the corporate of creating an “overbroad and half-baked” effort to warn sufferers by submitting an utility so as to add a warning label to each treatment containing MPA.
“Depo-Provera is 150 milligrams. Three, 4 instances a 12 months, a really excessive dose,” Relkin mentioned. “There are low-dose, 2.5 and 5 mg drugs, the place there’s no information exhibiting that they trigger an issue.”
“The dose makes the poison,” she added. “By asking to alter the label for all, they have been inviting a rejection.”
Pfizer denied that accusation in its court docket submitting. “If FDA really thought a meningioma warning was needed for some merchandise (and never others) … FDA may have ‘promptly’ communicated to Pfizer,” it wrote.
Adjustments overseas
Exterior of the U.S., nonetheless, adjustments have been made to Pfizer’s label.
The European Medicines Company added meningioma as a “attainable aspect impact” of medicine with excessive doses of medroxyprogesterone acetate in 2024, and Pfizer went on to talk that danger to docs within the European Union. Canada’s label for the drug, up to date in 2024, contains 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 useful updating the drug label for MPA to incorporate meningioma danger.
Phillip’s lawsuit alleges that Pfizer knew of the potential danger years earlier than these adjustments abroad have been made, nonetheless, citing a 2006 Canadian drug label which lists meningioma as one of many “Put up-Market Opposed Drug Reactions” — antagonistic occasions which might be reported after a drug has already been authorised. The 2006 label notes that “the character of post-marketing surveillance makes it tough to find out if a reported occasion was really attributable to DEPO-PROVERA.”
“Simply because one thing occurred related in time with one thing, it doesn’t imply that one factor prompted the opposite,” mentioned Dr. Janet Woodcock, a former FDA principal deputy commissioner. “It’s in an organization’s greatest curiosity to place all the pieces on there, as a result of then in the event that they’re sued, they’d say, ‘Properly, it was within the tremendous print.’”
Woodcock, who is just not concerned with the lawsuit, famous the FDA usually has the ultimate phrase on drug labels.
In response to Pfizer’s court docket filings, the corporate resubmitted its utility to the FDA in June 2025.
“FDA has nonetheless not authorised any meningioma warning, and Pfizer’s renewed request stays pending,” the submitting mentioned.
Relkin mentioned an earlier warning would have modified all the pieces for Phillip and her different shoppers.
After her surgical procedure in 2018, Phillip continued to take Depo-Provera. Her docs have been unable to take away the whole tumor in 2018 and he or she wanted a second surgical procedure in 2022, adopted by radiation remedy from 2022 to 2024.
Even nonetheless, docs weren’t capable of take away the whole tumor due to how shut it’s to her optic nerve.
Phillip says she continued taking Depo-Provera till she noticed posts on social media in 2024 concerning the research linking the drug to meningioma.
Earlier this month, she had her first set of mind scans since going off the drug. She mentioned her radiologist advised her that the meningioma is shrinking.
“My physique is telling me, my head is telling me I don’t have that a lot ache like I used to have,” she mentioned.
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