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Kids, they grow up so fast. One day they're taking their first steps and the next they don't fit into the tiny sneakers they took them in. You blink your eyes and their princess dress is two sizes too small. And their dinosaur backpack isn't cool anymore. But don't cry because they're growing up. Smile because you can profit off of it for real. There are a bunch of parents on depop looking for the stuff your kid just grew out of. Download depop to start selling.
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Depo Provera was approved back in 1992 by the US FDA. About 1 in 4 sexually active women in the US have used the shot at some point in their reproductive life. That's according to the cdc. Meningiomas are common intracranial tumors with a female predominance. In fact, they're the most common primary brain tumor in women. They have an incidence of about 12.7 per 100,000 in the general female population. Thankfully, the vast majority of these tumors are benign. In other words, they are World health organization grade one. But still, about 15 or 20% of these tumors can behave atypically called grade two. And rarely, in about 1 to 2% of cases, these tumors can be malignant. Those are the ones that are grade three. Now, we covered this relationship between Depo Provera as a contraceptive agent and brain meningioma back In March of 2024, just over a year ago. So this is still hot in press and it relates what we're talking about here because just within the last 24 hours from when we're recording this, the FDA has approved a medication label change for Depo Provera's manufacturer, Pfizer. This is a very, very big deal. As the association, as the data continues to build against Depo Provera, this association is pretty scary. Now remember, of course, association does not always prove causation. However, even from when we did the podcast back in March of 2024, this association is looking scarier and scarier. In this episode we're going to tackle and very briefly reviews ACOG's released statement about this. Shortly after all of this mess was going on around the spring of 2024, we're just going to state what they mentioned in their quote coun patients on birth control injection and in meningioma, end quote. That that's a very brief little guidance that ACOG put out. And again, it makes the point that causation is different than association. But nonetheless, as this data mounts, the FDA said, yeah, even though we previously denied that request for a warning I think we pretty much need to put that in there. Things are moving fast here in the world of Depo Provera and meningiomas. Listen in for details. This is Dr. Chapa's ob gyn no spin podcast. All right. Lots happening here in the world of Depo Provera and meningiomas. This is fascinating because guys, our episode wasn't long ago, March of 2024. I was still working with the ACOG leadership. We communicated about this. They put out that little guidance which we're briefly going to review here in just a couple of seconds. But from that point on, even that guidance may seem a little outdated. Now as the FDA goes, yeah, you need to put a warning on that. Now this is remarkable for two main things. Number one, we gotta know what the evidence is and the evidence is always evolving so that we' gonna talk about it. Number two, the FDA actually changed course here. So originally the FDA denied Pfizer, the manufacturer of this medication. Their label changed because they're like, yeah, you know what, these are observational studies. You know, we don't wanna freak people out. Meningiomas are the most common primary brain tumor in women anyway. Thankfully, the vast majority are benign, even though they can still cause a lot of issues with mass effect headaches. If they're in the right spot, they cause vision changes, not minimizing the fact that they're benign, that they're not worri. But the FDA originally denied the label change. However, now, as you know, the patient claims are over 1,000 and Pfizer's looking at, well, as in a medical legal suit, there may be enough there to put a label change. And that's why the FDA said, yeah, I think it's time let's go ahead and put the wording in there and warn about this potential association. We're going to talk about that briefly now before we take a look at that data when that actually looks like. Let's just quickly restate ACOG's guidance on this, which happened around this time of all this controversy when these studies first started coming out, even though some earlier studies can be tracked back over a decade ago. Okay, so ACOG's statement on that patient centered, shared decision making, you know, little info sheet is very brief. The recent study showed that women in France who use medroxyprogesterone acetate may have a small increased risk of meningioma, but the overall risk of meningioma in the general population remains very low. Now, according to that study, it was 5 out of 10,000 women using medroxyprogesterone acetate may possibly develop meningioma compared to 1 out of 10,000 women who were not using the medication. All right, so this study said in France, hey, women on depo 5 per 10,000 got a meningoma in general population is 1 out of 10,000. So that is a 5 fold increase even though relative risk is different than absolute number. And so ACOG said it's important to interpret the results of this study with caution, as noted in a response from bmj, because this study has several limitations as it warrants further research, end quote. They also go on to say that there's a difference, as we've already mentioned and as we've said many times before, between association and causation. And the important thing is that women have access to good, reliable birth control. However. However, things move fast. So much so that on December 17, 2025, as we've already stated, regulators through the FDA said, yeah, we need to follow what other countries have already done and we're the par. The parent country rather of this medication being the U.S. so it's interesting because last year in 2024, European and Canadian health agencies already went to the label change and put meningioma as a warning. Okay, so we're kind of behind the ball on this as the parent country and company being Pfizer for Depo Provera. So once again, European and Canadian health agencies did change their label in 2024. So let's put this all in the proper perspective and then very quickly, very quickly go over the association between Duo Provera and Meningioma. The take home message here is very simple. Guys, I'm gonna give you three, three. Number one, good birth control is super important. Number two, it's all elective. It's birth control. Pick something else. All right? Especially in adolescence with a whole bone issue effect, even though it's reversible. Now, potentially with this issue with long term use, I wanna be very clear and I'll get into it in a minute. This isn' who gets one shot of Depo. Typically this is with prolonged use, meaning greater than four years or when depo is started after the age of 31. Okay, so let's say that again, this, this risk, which the relative risk seems to be about 2.4, right? So it's a double of the risk with a confidence interval which is to the right and away from one. And it's a narrow confidence interval, guys. That's what matters here. We covered this in our immediately past podcast. When we talked about lubing up the vagina to get the kid out, that second stage, where, you know, broad confidence intervals means less reliable. But this confidence interval, according to a 2025 US cohort study that gave a relative risk of developing this brain tumor after Depo Provera exposure of 2.43, the confidence interval was 1.7 to 3.3. Okay, did you catch that? So while the relative risk is impressive, 2.43 and the confidence interval is narrow, which is super important, we don't want a broad confidence interval. We just talked about that again in the immediately past episode. But the confidence interval was 1.7 to 3.3. So it is narrow, but it still included 1. Now, it trended towards the right of 1. In other words, the pull was towards association. But the lower end of the confidence interval did include 1.1.77. Which is why you have to understand stat, relative risk of 2.43 is important. However, the confidence interval was 1.7 to 3.3. Raising a little flag of, well, is, you know, is that a real risk or not? However, that's just the one study from 2023, and there are others. Okay, now let's go back and look at the other population studies. According to a Swedish registry study that found an even stronger association. Here it is, guys. With an odds ratio of 5.49. Now listen to these 95% confidence intervals. Remember, we don't want to cross one and we want it to be up towards the right of one. In other words, an increase association if this thing is real. Okay, so listen to this Swedish registry study. Odds ratio of 5.4 with a 95% confidence interval of 4.5 to 6.6. Narrow and definitely away from 1. That's concerning. So at the lower end, we got a relative risk of 2.4. At the higher end, an odds ratio of 5.49. These are worrisome associations. Remember, these are population studies which do not prove causation. Now, that study, that original French study that we mentioned in the intro and that ACOG referenced as well, that was a case control study and found very similar. That odds ratio, remember, was. And that 95% confidence interval was 2.2 to 13.56. The issue with this study is that while the odds ratio was very high at 5 and the confidence interval was away from 1, it was very broad. It was 2 to 13. Again raising the concern about reliability and accuracy or precision in the data. So we've got several large publications. US cohort study, the Swedish study, the French Study. All of them are saying, guys, there's something here. The degree to which they say something here varies from up to 5 to the lower risk of twice the risk, which, again, absolute number still very small, with confidence intervals that are in general away from one towards the right, showing increased prevalence or increased risk. But some of those do get very darn close to the number one. So this is an issue here. Okay, so let me give you. When you're gonna talk to a patient, here's what I would do and what I've been doing. Hey, there's a lot of different forms of bur control. If you're going to use depo, knock yourself out. But try to use it for the shortest amount of time possible, and try to start that under the age of 31, because those seem to be the two big qualifying risk factors here. It's not just getting one shot of depo. It's prolonged depo, again, more than four years and or starting over the age of 31. Okay? So both of those things seem to matter here. And I would tell patients that the absolute risk still remains low. So we don't want to freak people out, but we also want to not ignore the data and not be very quick to dismiss it as well. Association does improve causation, y'. All. For a long time, there was an association between tobacco smoking and lung cancer. Okay? So for, like. For a long time, they're like, we're seeing a lot of stuff here. And all of the scientific community was like, please, my doctor smokes Camel. You'll be fine. Y' all remember, you've seen those ads. I was not around at that time, but 1950s, you know, black and white ads. And literally it was a doctor smoking his Camel Camel cigarette, which was unfiltered, for heaven's sake, so right into the lungs. And then said, the doctor's choice for cigarettes is Camel. Okay? And then the association started popping up. And now, of course, we know that it's not just an association between tobacco and lung cancer and emphysema and copd. It is a true causation. So good, so good, so good. Score holiday gifts. Everyone wants for way less at your Nordstrom Rack store. Save on Ugg, Nike, Rag and Bone, Vince Frame, Kurt Geiger, London, and more. Cause there's always something new. I'm giving all the gifts this year with that extra 5% off when I use my Nordstrom credit card. 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So I'm not saying here, I'll be very clear. Don't send me an ugly message. Don't send me an ugly message because I'm gonna have Michael intercepted anyway or somebody on our Mortal Kom team. But nonetheless, I get it. These are associations. But after a while you have to say, man, there's a lot here. We're have to put this thing maybe on a bench model and prove that what we see here on bench is actually happening in vivo. There is biological plausibility for this. And we covered this in March of 2024. We're gonna do this very quickly, guys, and we're gonna be done. Yes, Meningiomas like them some progesterone, okay? So they've got little progesterone towers. And so these things go nuts. 75% of meningiomas express progesterone receptors. And according to some case reports that have been published, the good news is, is that when you find it, and it seems to be temporally related to Depo Provera, once you stop the medication, which is what you're supposed to do about 30% of the time, there can be some decrease in their size or complete regression. Okay? And that is something that's been seen across multiple populations, again from us, the French and the Swedish databases, that there definitely is this plausibility here where this thing would make sense. Now, the scary medication seems to be depo for birth control, either in the 150 IM or even the sub Q form because there is a subcutaneous form of 104 milligrams. Okay? That's. It's the big depo dose that seems to be the issue here because there is a dose response relationship. Guys, a lot of clinical pearls here, right? Greater than four years, starting later on in life. Dose response relationship. Meningiomas have progesterone antennas. These are all quick facts to keep in your head as you talk to a patient. However, because it's that big dose that Depo is given, as for contraception, whether it's sub Q or im, the data does not really seem to apply to oral medroxyprogesterone acetate to oral Provera. Okay? So if you have somebody that you need to do a test of withdrawal bleed because they have, you know, delayed menses, please give them their oral Provera. And if you want to stay away from it, fine, you can give them a natural progesterone like a prometrium. But that this does not have to do with oral Provera. To be very clear. Now, it's possible that that's a thing, but right now the odds ratio for that is like 1.1 with 95% confidence intervals that don't escape one. Like, one study showed 1.1 to 1.2. Okay, so to be very clear, this is only for birth control dose of medroxyprogesterone acetate as either IM or sub Q form, not as oral medication. Nor does it have anything to do with other contraceptive methods. So this does not have to do with combined birth control pills. This has nothing to do with eternalgesterol. That's different. And this has nothing to do with intrauterine progesterone systems. I'm going to be very clear. This is strictly for Depo Provera as either IM or the sub Q form. This is only for Depo Provera in the IM or sub Q form, not oral Provera, not IUDs, not combined birth control pills and not the etonorgestrel implant. Those are different based on their metabolism in the body and or dose response. Okay, so this is the latest. I just wanted to get this out very quickly. We do have three countries now. The US Of A, France, Sweden, all that are saying, guys, I think there's something here. And the latest One was a 2025 U.S. cohort study, again from the U.S. that kind of raise these alarms. And I think we definitely need to be concerned about this. When there's so many different contraceptive agents out there. It's not like they've got to use depo or there's nothing else. That publication from 2025 from the US was out of JAMA Neurology, okay? That was depo medroxyprogesterone acetate and the risk of meningioma in the United States. Now, remember? So this is after that acog, you know, release came out. That's why medicine moves fast. That's why we're doing this here. So now we have us French and Swedish populations saying maybe this might could be an issue. Podcast family. We've covered the very recent, like, within 24 hours, FDA approval of a label change that is coming very, very soon with a warning for depo Provera, either IM or sub Q formats and the risk of meningioma. Now, Pfizer did say, if we're gonna, we're gonna put a label on this thing as a warning, then please include oral Provera. Okay, so I wanna be very clear. In one of the petitions, Pfizer said, I know that this is the birth control medication that's under fire, but we just wanna throw that in there just to be done with this thing. So there is a petition to include that even though the data does not seem to support a risk which with oral medroxyprogesterone acetate in typical form or in birth control pills. Right. So I'm very clear. While Pfizer did petition for all oral medroxyprogesterone acetate or medroxyprogesterone acetate in general, the risk is specifically for the contraceptive dose. Okay. Of course, I'll put all of these references, including the link to our previous podcast in the show Notes. As always, podcast family, we're thankful for you. You. We're glad you're part of our podcast community. I think we've done what we're supposed to do here. And now, having said all that, let's take it home. Foreign. This has been Dr. Chapa Zobi Gyn, no Spin podcast Podcast family. Thank you for your support. Thank you for listening. And as always, we'll see you on another episode of the no Spin Podcast. Sam.