Makena Recall

Emily Oster

3 min Read Emily Oster

Emily Oster

Approximately 10% of births in the U.S. are preterm, defined as before 37 completed weeks of pregnancy. Although many premature babies do well and have no long-term differences, preterm birth is associated with higher risks of later developmental issues. This is more common the more preterm the baby is. In some cases, the reason for a preterm birth is known, but often it’s not. Even more challenging, we have little idea of what interventions can prevent preterm birth.

One long-standing theory is that low levels of the hormone progesterone could play a role in raising the risk of preterm birth; this was a potential avenue for treatment, since progesterone can be elevated, either through vaginal suppositories or through injections. In 2003, a study in the New England Journal of Medicine seemed to support the use of injectable progesterone to lower preterm birth. The study — a randomized trial with a total of about 460 women — showed a 33% reduction in the risk of preterm birth.

This finding increased the desire to use the medication with women at risk of preterm birth. Until 2011, however, there was no standard version of the product and it had to be accessed by special request at compounding pharmacies. In 2011 the FDA approved a standard form of this drug called Makena. As part of this process, the FDA required the company that received the approval to fund a larger efficacy study.

That study, published in 2020, enrolled 1,700 women. And the authors did not find any differences in preterm birth — the rate of birth before 35 weeks was 11% in the treatment group, 11.5% in the control group.

Over the past couple of years, there has been a lot of back-and-forth on this. There has been pressure on the FDA to rescind approval of what is, basically, a very expensive drug with limited demonstrated efficacy. On the other side, supporters of Makena argue that the second trial enrolled a much lower risk sample (the preterm birth rate in the control group is 11.5%, versus 50% in the original trial), so maybe with a higher risk sample there would be more impacts. A 2021 meta-analysis combining all these studies suggested that there might be some small effects, adding to the confusion.

Finally, within the past few weeks the FDA has recommended that approval be rescinded, based on lack of demonstrated efficacy. Confusingly, though, doctors and patients may still be able to access this drug through compounding pharmacies, just as you could before the Makena approval. It’s a mess!

Where does this leave us? First, if you were prescribed Makena in the past and are now worried, don’t be. There isn’t any information here to suggest you should be concerned. Second, it seems unlikely that injectable progesterone will be prescribed much going forward, even if it could be accessed outside these branded channels. There is limited loss associated with this; the impacts, even if they are there, are small.

The bottom line is that preterm birth, and the prevention of it, remains a mystery and there remains more to do and understand.

Thanks to Dr. Nathan Fox for help on this question.

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Potty training can feel like a Mount Everest-size challenge, and sadly, our evidence-based guidance is poor. So, I created a survey to collate advice and feedback on success from about 6,000 participants.

How long does potty training take? We found that there is a strong basic pattern here: the later you wait to start, the shorter time it takes to potty train. On average, people who start at under 18 months report it takes them about 12 weeks for their child to be fully trained (using the toilet consistently for both peeing and pooping). For those who start between 3 and 3.5, it’s more like nine days. Keep in mind that for all of these age groups, there is a range of length of time from a few days to over a year. Sometimes parents are told that if you do it right, it only takes a few days. While that is true for some people, it is definitely not the norm.

If you’re in the throes of potty training, hang in there! 

#emilyoster #parentdata #pottytraining #pottytrainingtips #toddlerlife

Potty training can feel like a Mount Everest-size challenge, and sadly, our evidence-based guidance is poor. So, I created a survey to collate advice and feedback on success from about 6,000 participants.

How long does potty training take? We found that there is a strong basic pattern here: the later you wait to start, the shorter time it takes to potty train. On average, people who start at under 18 months report it takes them about 12 weeks for their child to be fully trained (using the toilet consistently for both peeing and pooping). For those who start between 3 and 3.5, it’s more like nine days. Keep in mind that for all of these age groups, there is a range of length of time from a few days to over a year. Sometimes parents are told that if you do it right, it only takes a few days. While that is true for some people, it is definitely not the norm.

If you’re in the throes of potty training, hang in there!

#emilyoster #parentdata #pottytraining #pottytrainingtips #toddlerlife
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For children or adults with severe food allergies, they can be incredibly scary and restrictive. We may imagine that it’s easy to deal with a peanut allergy by, say, not eating peanut butter sandwiches. But for someone with a severe version of this allergy, they may never be able to go to a restaurant, for fear of a severe reaction to something in the air. Right now, there’s only one approved treatment for severe allergies like this and it’s limited to peanuts.

This is why the new medication Xolair is very exciting. It promises a second possible treatment avenue and one that works for other allergens. A new trail analyzed data from 177 children with severe food allergies. Two-thirds of the treatment group were able to tolerate the specified endpoint, versus just 7% of the placebo group. This is a very large treatment effect, and the authors found similarly large impacts on other allergens. 

There are some caveats: This treatment won’t work for everyone. (One-third of participants did not respond to it.) Additionally, this treatment is an injection given every two to four weeks, indefinitely. This may make it less palatable to children. 

Overall, even with caveats, this is life-changing news for many families!

#xolair #foodallergies #allergies #peanutallergy #emilyoster #parentdata

For children or adults with severe food allergies, they can be incredibly scary and restrictive. We may imagine that it’s easy to deal with a peanut allergy by, say, not eating peanut butter sandwiches. But for someone with a severe version of this allergy, they may never be able to go to a restaurant, for fear of a severe reaction to something in the air. Right now, there’s only one approved treatment for severe allergies like this and it’s limited to peanuts.

This is why the new medication Xolair is very exciting. It promises a second possible treatment avenue and one that works for other allergens. A new trail analyzed data from 177 children with severe food allergies. Two-thirds of the treatment group were able to tolerate the specified endpoint, versus just 7% of the placebo group. This is a very large treatment effect, and the authors found similarly large impacts on other allergens.

There are some caveats: This treatment won’t work for everyone. (One-third of participants did not respond to it.) Additionally, this treatment is an injection given every two to four weeks, indefinitely. This may make it less palatable to children.

Overall, even with caveats, this is life-changing news for many families!

#xolair #foodallergies #allergies #peanutallergy #emilyoster #parentdata
...

If you have a fever during pregnancy, you should take Tylenol, both because it will make you feel better and because of concerns about fever in pregnancy (although these are also overstated).

The evidence that suggests risks to Tylenol focuses largely on more extensive exposure — say, taking it for more than 28 days during pregnancy. There is no credible evidence, even correlational, to suggest that taking it occasionally for a fever or headache would be an issue.

People take Tylenol for a reason. For many people, the choice may be between debilitating weekly migraines and regular Tylenol usage. The impacts studies suggest are very small. In making this decision, we should weigh the real, known benefit against the suggestion of this possible risk. Perhaps not everyone will come out at the same place on this, but it is crucial we give people the tools to make the choice for themselves.

#emilyoster #parentdata #tylenol #pregnancy #pregnancytips

If you have a fever during pregnancy, you should take Tylenol, both because it will make you feel better and because of concerns about fever in pregnancy (although these are also overstated).

The evidence that suggests risks to Tylenol focuses largely on more extensive exposure — say, taking it for more than 28 days during pregnancy. There is no credible evidence, even correlational, to suggest that taking it occasionally for a fever or headache would be an issue.

People take Tylenol for a reason. For many people, the choice may be between debilitating weekly migraines and regular Tylenol usage. The impacts studies suggest are very small. In making this decision, we should weigh the real, known benefit against the suggestion of this possible risk. Perhaps not everyone will come out at the same place on this, but it is crucial we give people the tools to make the choice for themselves.

#emilyoster #parentdata #tylenol #pregnancy #pregnancytips
...

Parenting trends are like Cabbage Patch Kids: they’re usually only popular because a bunch of people are using them! Most of the time, these trends are not based on new scientific research, and even if they are, that new research doesn’t reflect all of what we’ve studied before.

In the future, before hopping onto the latest trend, check the data first. Unlike Cabbage Patch Kids, parenting trends can add a lot of unnecessary stress and challenges to your plate. What’s a recent trend that you’ve been wondering about?

#parentdata #emilyoster #parentingtips #parentingadvice #parentinghacks

Parenting trends are like Cabbage Patch Kids: they’re usually only popular because a bunch of people are using them! Most of the time, these trends are not based on new scientific research, and even if they are, that new research doesn’t reflect all of what we’ve studied before.

In the future, before hopping onto the latest trend, check the data first. Unlike Cabbage Patch Kids, parenting trends can add a lot of unnecessary stress and challenges to your plate. What’s a recent trend that you’ve been wondering about?

#parentdata #emilyoster #parentingtips #parentingadvice #parentinghacks
...

As of this week, 1 million copies of my books have been sold. This feels humbling and, frankly, unbelievable. I’m so thankful to those of you who’ve read and passed along your recommendations of the books.

When I wrote Expecting Better, I had no plan for all of this — I wrote that book because I felt compelled to write it, because it was the book I wanted to read. As I’ve come out with more books, and now ParentData, I am closer to seeing what I hope we can all create. That is: a world where everyone has access to reliable data, based on causal evidence, to make informed, confident decisions that work for their families.

I’m so grateful you’re all here as a part of this, and I want to thank you! If you’ve been waiting for the right moment to sign up for full access to ParentData, this is it. ⭐️ Comment “Link” for a DM with a discount code for 20% off of a new monthly or annual subscription to ParentData! 

Thank you again for being the best community of readers and internet-friends on the planet. I am so lucky to have you all here.

#parentdata #emilyoster #expectingbetter #cribsheet #familyfirm #parentingcommunity

As of this week, 1 million copies of my books have been sold. This feels humbling and, frankly, unbelievable. I’m so thankful to those of you who’ve read and passed along your recommendations of the books.

When I wrote Expecting Better, I had no plan for all of this — I wrote that book because I felt compelled to write it, because it was the book I wanted to read. As I’ve come out with more books, and now ParentData, I am closer to seeing what I hope we can all create. That is: a world where everyone has access to reliable data, based on causal evidence, to make informed, confident decisions that work for their families.

I’m so grateful you’re all here as a part of this, and I want to thank you! If you’ve been waiting for the right moment to sign up for full access to ParentData, this is it. ⭐️ Comment “Link” for a DM with a discount code for 20% off of a new monthly or annual subscription to ParentData!

Thank you again for being the best community of readers and internet-friends on the planet. I am so lucky to have you all here.

#parentdata #emilyoster #expectingbetter #cribsheet #familyfirm #parentingcommunity
...

Just eat your Cheerios and move on.

Just eat your Cheerios and move on. ...

The AAP’s guidelines recommend sleeping in the same room as your baby “ideally for the first six months.” However, the risk of SIDS is dramatically lower after four months, and the evidence in favor of the protective effect of room sharing is quite weak (both overall and even more so after four months). There is also growing evidence that infants who sleep in their own room by four months sleep better at four months, better at nine months, and even better at 30 months.

With this in mind, it’s worth asking why this recommendation continues at all — or at least why the AAP doesn’t push it back to four months. They say decreased arousals from sleep are linked to SIDS, which could mean that babies sleeping in their own room is risky. But this link is extremely indirect, and they do not show direct evidence to support it.

According to the data we have, parents should sleep in the same room as a baby for as long as it works for them! Sharing a room with a child may have negative impacts on both child and adult sleep. We should give families more help in navigating these trade-offs and making the decisions that work best for them.

#emilyoster #parentdata #roomsharing #sids #parentingguide

The AAP’s guidelines recommend sleeping in the same room as your baby “ideally for the first six months.” However, the risk of SIDS is dramatically lower after four months, and the evidence in favor of the protective effect of room sharing is quite weak (both overall and even more so after four months). There is also growing evidence that infants who sleep in their own room by four months sleep better at four months, better at nine months, and even better at 30 months.

With this in mind, it’s worth asking why this recommendation continues at all — or at least why the AAP doesn’t push it back to four months. They say decreased arousals from sleep are linked to SIDS, which could mean that babies sleeping in their own room is risky. But this link is extremely indirect, and they do not show direct evidence to support it.

According to the data we have, parents should sleep in the same room as a baby for as long as it works for them! Sharing a room with a child may have negative impacts on both child and adult sleep. We should give families more help in navigating these trade-offs and making the decisions that work best for them.

#emilyoster #parentdata #roomsharing #sids #parentingguide
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It was an absolute pleasure to be featured on the @tamronhallshow! We talked about all things data-driven parenting and, in this clip, what I call the plague of secret parenting. To balance having a career and having a family, we can’t hide the fact that we’re parents. If mothers and fathers at the top can speak more openly about child-care obligations, it will help us all set a new precedent.

Watch the full segment at the link in my bio 🔗

#tamronhall #tamronhallshow #emilyoster #parentingsupport #workingparents

It was an absolute pleasure to be featured on the @tamronhallshow! We talked about all things data-driven parenting and, in this clip, what I call the plague of secret parenting. To balance having a career and having a family, we can’t hide the fact that we’re parents. If mothers and fathers at the top can speak more openly about child-care obligations, it will help us all set a new precedent.

Watch the full segment at the link in my bio 🔗

#tamronhall #tamronhallshow #emilyoster #parentingsupport #workingparents
...

Invisible labor. It’s the work — in our households especially — that has to happen but that no one sees. It’s making the doctor’s appointment, ensuring birthday cards are purchased, remembering the milk.

My guest on this episode, @everodsky, has come up with a solution here, or at least a way for us to recognize the problem and make our own solutions. I’ve wanted to speak with Eve for ages, since I read her book Fair Play. We had a great conversation about the division of household labor, one I think you’ll get a lot out of!

Listen and subscribe to ParentData with Emily Oster in your favorite podcast app 🎧

#emilyoster #parentdata #parentdatapodcast #parentingpodcast #householdtips #fairplay #invisiblelabor

Invisible labor. It’s the work — in our households especially — that has to happen but that no one sees. It’s making the doctor’s appointment, ensuring birthday cards are purchased, remembering the milk.

My guest on this episode, @everodsky, has come up with a solution here, or at least a way for us to recognize the problem and make our own solutions. I’ve wanted to speak with Eve for ages, since I read her book Fair Play. We had a great conversation about the division of household labor, one I think you’ll get a lot out of!

Listen and subscribe to ParentData with Emily Oster in your favorite podcast app 🎧

#emilyoster #parentdata #parentdatapodcast #parentingpodcast #householdtips #fairplay #invisiblelabor
...

Prenatal vitamins 💊 If there is any product that seems designed to prey on our fears, it’s this one. You’re newly pregnant and you want to do it right. Everyone agrees you need prenatal vitamins, so you get them. But do you want to be that person who just… buys the generic prenatal vitamins?

Good news: fancier vitamins are not better.  Folic acid is the most important prenatal ingredient. Iron (with vitamin C) and DHA are also nice to have. Other included ingredients have only weak or no evidence to support their use. (If you do not consume animal products, add B12, plus a few others depending on your diet.)

Vitamins are just vitamins. Any prenatal vitamin that contains these is enough. 

Comment “Link” for a DM to an article with everything you need to know about prenatal vitamins.

#emilyoster #parentdata #prenatalvitamins #pregnancydiet #pregnancytips

Prenatal vitamins 💊 If there is any product that seems designed to prey on our fears, it’s this one. You’re newly pregnant and you want to do it right. Everyone agrees you need prenatal vitamins, so you get them. But do you want to be that person who just… buys the generic prenatal vitamins?

Good news: fancier vitamins are not better. Folic acid is the most important prenatal ingredient. Iron (with vitamin C) and DHA are also nice to have. Other included ingredients have only weak or no evidence to support their use. (If you do not consume animal products, add B12, plus a few others depending on your diet.)

Vitamins are just vitamins. Any prenatal vitamin that contains these is enough.

Comment “Link” for a DM to an article with everything you need to know about prenatal vitamins.

#emilyoster #parentdata #prenatalvitamins #pregnancydiet #pregnancytips
...

When it comes to introducing your newborn to the world, timing matters. It’s a good idea to minimize germ exposure in the first 6-8 weeks; after that, it’s inevitable and, very likely, a good idea! This doesn’t mean you need to be trapped inside. The most significant exposure risks are from seeing other people at home — family, etc. These interactions are not infinitely risky, but they do pose more risk than a walk or a trip to the grocery store, since they involve closer interaction. Think simple and make sure everyone is washing their hands before holding the baby. 💛

#parentdata #emilyoster #newborncare #parentingadvice #parentingtips

When it comes to introducing your newborn to the world, timing matters. It’s a good idea to minimize germ exposure in the first 6-8 weeks; after that, it’s inevitable and, very likely, a good idea! This doesn’t mean you need to be trapped inside. The most significant exposure risks are from seeing other people at home — family, etc. These interactions are not infinitely risky, but they do pose more risk than a walk or a trip to the grocery store, since they involve closer interaction. Think simple and make sure everyone is washing their hands before holding the baby. 💛

#parentdata #emilyoster #newborncare #parentingadvice #parentingtips
...

The first edition of Hot Flash is out now! Comment “Link” for a DM to learn more about the late-reproductive stage.

There are times when we expect hormonal shifts. Our reproductive lives are bookended by puberty and menopause. We discuss those changes often because they are definitive and dramatic — a first period is something many of us remember clearly. But between ages 13 and 53, our hormones are changing in more subtle ways. During the late-reproductive stage (in your 40s), you can expect a lot of changes in your menstrual cycle, including the length and symptoms you experience throughout. It’s an important time in our lives that is often overlooked!

🔥 Hot Flash from ParentData is a weekly newsletter on navigating your health and hormones in the post-reproductive years. Written by Dr. Gillian Goddard, Hot Flash provides all of the information you need to have a productive, evidence-based conversation about hormonal health with your doctor.

#emilyoster #parentdata #hotflash #perimenopause #womenshealth

The first edition of Hot Flash is out now! Comment “Link” for a DM to learn more about the late-reproductive stage.

There are times when we expect hormonal shifts. Our reproductive lives are bookended by puberty and menopause. We discuss those changes often because they are definitive and dramatic — a first period is something many of us remember clearly. But between ages 13 and 53, our hormones are changing in more subtle ways. During the late-reproductive stage (in your 40s), you can expect a lot of changes in your menstrual cycle, including the length and symptoms you experience throughout. It’s an important time in our lives that is often overlooked!

🔥 Hot Flash from ParentData is a weekly newsletter on navigating your health and hormones in the post-reproductive years. Written by Dr. Gillian Goddard, Hot Flash provides all of the information you need to have a productive, evidence-based conversation about hormonal health with your doctor.

#emilyoster #parentdata #hotflash #perimenopause #womenshealth
...

There are plenty of reels telling you how to parent. Plenty of panic headlines saying that “studies show” what’s best for your kid. Even good data, from a trusted source, can send us into a spiral of comparison. But I want you to remember that no one knows your kid better than you. It’s important to absorb the research, but only you will know the approach that works best for you and your child. 💙

Now tell me in the comments: what’s a parenting move you’ve made recently that feels right to you?

#parentingcommunity #parentingsupport #parentingquotes #emilyoster #parentdata

There are plenty of reels telling you how to parent. Plenty of panic headlines saying that “studies show” what’s best for your kid. Even good data, from a trusted source, can send us into a spiral of comparison. But I want you to remember that no one knows your kid better than you. It’s important to absorb the research, but only you will know the approach that works best for you and your child. 💙

Now tell me in the comments: what’s a parenting move you’ve made recently that feels right to you?

#parentingcommunity #parentingsupport #parentingquotes #emilyoster #parentdata
...

Let’s talk about sex (after) baby! Today on the podcast, I was lucky enough to speak with @enagoski about her new book on sexual connection in long-term relationships. Especially after having kids, this is something many people struggle with. Emily tells us to stop worrying about what’s “normal” and focus on pleasure in its many forms.

Listen and subscribe to ParentData with Emily Oster in your favorite podcast app 🎧

#parentdata #parentdatapodcast #emilyoster #emilynagoski #comeasyouare #cometogether #longtermrelationship #intimacy #relationships

Let’s talk about sex (after) baby! Today on the podcast, I was lucky enough to speak with @enagoski about her new book on sexual connection in long-term relationships. Especially after having kids, this is something many people struggle with. Emily tells us to stop worrying about what’s “normal” and focus on pleasure in its many forms.

Listen and subscribe to ParentData with Emily Oster in your favorite podcast app 🎧

#parentdata #parentdatapodcast #emilyoster #emilynagoski #comeasyouare #cometogether #longtermrelationship #intimacy #relationships
...

Ever wondered if you can safely use leftover baby formula? 🍼 The CDC says to throw out unused formula immediately because of the risk of bacterial growth. However, research suggests that bacterial concentrations do not appreciably increase after 3, 12, or even 24 hours at refrigerator temperatures. Good news! This means there’s not a strong data-based reason to throw out formula right away if you store it in the fridge.

Comment “Link” for a DM to an article on another common formula question: should you throw away old formula powder?

#emilyoster #parentdata #babyformula #babyfeeding #parentingstruggles

Ever wondered if you can safely use leftover baby formula? 🍼 The CDC says to throw out unused formula immediately because of the risk of bacterial growth. However, research suggests that bacterial concentrations do not appreciably increase after 3, 12, or even 24 hours at refrigerator temperatures. Good news! This means there’s not a strong data-based reason to throw out formula right away if you store it in the fridge.

Comment “Link” for a DM to an article on another common formula question: should you throw away old formula powder?

#emilyoster #parentdata #babyformula #babyfeeding #parentingstruggles
...

What’s the most important piece of advice for new parents? Here’s one answer, but I want to hear from you! Share your suggestions in the comments ⬇️

#emilyoster #parentdata #parentingtips #parentingadvice #newparents #parentingcommunity

What’s the most important piece of advice for new parents? Here’s one answer, but I want to hear from you! Share your suggestions in the comments ⬇️

#emilyoster #parentdata #parentingtips #parentingadvice #newparents #parentingcommunity
...

What's in the bag of a Vagina Economist? 👀 Someone please tell me this looks familiar to you.

What`s in the bag of a Vagina Economist? 👀 Someone please tell me this looks familiar to you. ...