In this “Quick Verdicts” episode, hosts Don Weinberger and Steve Small separate fact from fiction about whether acetaminophen use during pregnancy increases the risk of neurologic disorders in kids.
TRC Healthcare Editor Hosts:
- Stephen Small, PharmD, BCPS, BCPPS, BCCCP, CNSC
- Don Weinberger, PharmD, PMSP
The clinical resources mentioned during the podcast are part of a subscription to Pharmacist’s Letter, Pharmacy Technician’s Letter, and Prescriber Insights:
- Chart: Glossary of Study Design and Statistical Terms
- Chart: Analgesics in Pregnancy and Lactation
- Chart: Topical Medications in Pregnancy and Lactation
- Toolbox: Resources for Discussing Medical Misinformation
- Article: Put New Acetaminophen Pregnancy Warnings in Perspective
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Transcript:
This transcript is automatically generated.
00:00:05 Narrator
Welcome to Rumor vs Truth, your trusted source for facts… where we dissect the evidence behind risky rumors and reveal clinical truths.
00:00:11 Narrator
Today, we’ll breakdown FDA’s recent announcement about new pregnancy warnings for acetaminophen.
00:00:21 Steve Small
And don’t take this the wrong way, Don, but it’s weird to see you off schedule like this right now.
00:00:27 Don Weinberger
Yeah, I know we’re used to recording our Rumor vs Truth podcast episodes on certain days, but we wanted to address the large number of questions we received about FDA’s recent announcement about new pregnancy warnings with the acetaminophen (Tylenol) that have made the news.
00:00:40 Steve Small
And before we dive into the evidence, I’m Steve Small, PharmD… a pharmacist here at TRC healthcare.
00:00:47 Don Weinberger
And I’m Don Weinberger, PharmD… also a pharmacist here at TRC Healthcare.
00:00:50 Steve Small
And in this episode we’re trying something different. Instead of our typical setup of four to five claims, we’re gonna do a deep dive on a single claim.
00:00:58 Steve Small
We’re calling it Rumor vs Truth, Quick Verdicts.
00:01:02 Don Weinberger
Short, focused and in this case, very topical with what’s making headlines.
00:01:07 Don Weinberger
And folks, we know our show typically has some puns and light banter, but for this one, we’re going to keep it very straightforward to be clear in our guidance. So with that…
00:01:17 Steve Small
Yeah, the claim on everyone’s mind right now is “Acetaminophen in pregnancy causes neurologic disorders in kids,” things like autism.
00:01:26 Steve Small
And as you’ve probably heard, FDA announced on September 22nd that they’ve quote,
00:01:30 Steve Small
“initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children.”
00:01:46 Steve Small
ADHD, meaning attention deficit hyperactivity disorder.
00:01:51 Don Weinberger
Right, right. So, Steve. What’s the evidence here?
00:01:56 Don Weinberger
You know, this is a huge claim, right? Considering autism spectrum disorder has been identified in about one in every 30 kids who are 8 years old.
00:02:04 Steve Small
Right. This might seem nitpicky here, but it all boils down to the use of the word “cause” in this claim.
00:02:11 Steve Small
The FDA even says in their announcement quote, “a causal relationship has not been established and there are contrary studies in the scientific literature.”
00:02:20 Steve Small
And to back up here, there are studies that do suggest a very small association between acetaminophen use in pregnancy and neurologic issues in children such as autism.
00:02:32 Steve Small
But this association was only shown with long term chronic use, such as over one month not as needed, short term use…
00:02:42 Steve Small
And keep in mind, Don, these studies were not randomized placebo-controlled trials. This data is mostly animal studies and observational studies in humans.
00:02:51 Don Weinberger
Sure. So back up. So observational studies, right, that’s…
00:02:56 Don Weinberger
That’s when we watch a group of people and look at what they’ve been exposed to in everyday life. In this case, acetaminophen, right, and see if they have an increased risk of a certain outcome.
00:03:05 Don Weinberger
Again, in this case, autism, very different from a randomized placebo-controlled trial.
00:03:10 Steve Small
Very different. And here’s the kicker, the observational studies cannot and will not determine cause, they’re not designed to do that, they can only show an association based on their design.
00:03:23 Don Weinberger
Important. Yeah, plus observational studies can have important limitations from confounding and bias that may cause the results to be over or underestimated.
00:03:32 Steve Small
Very true. And we should say for our listeners who aren’t familiar with terms like bias and confounding or general statistics, we have a great resource Glossary of Study Design and Statistical Terms to help you out.
00:03:45 Don Weinberger
I’m really glad you pointed that one out.
00:03:46 Don Weinberger
So this resource defines confounding factor as “additional factors that distort the interaction between the treatment and the outcome.”
00:03:54 Don Weinberger
So a good example of this is that high fevers in pregnancy are also associated with neurological conditions in kids and acetaminophen is commonly used to treat fevers.
00:04:04 Don Weinberger
So how could we tell which is contributing to the outcome?
00:04:07 Steve Small
Yeah, and a bias is a flaw in the design or operation of a study that leads to results that are not the truth.
00:04:15 Steve Small
For example, many of these studies had moms self-report if they took acetaminophen months prior in pregnancy.
00:04:22 Steve Small
And this is a flaw because if their child had a problem, perhaps, they may be more likely to remember that they took acetaminophen, and we call this recall bias, great example.
00:04:33 Don Weinberger
Yeah. No. Speaking of that, you know, needing to look back and remember when you took something is difficult just on its own.
00:04:40 Don Weinberger
Recalling myself if I took acetaminophen in the past three weeks, I couldn’t tell you.
00:04:45 Steve Small
Right?
00:04:46 Don Weinberger
Maybe? And the dose. You know, I couldn’t really tell you. So, this actually pokes holes in a lot of that data.
00:04:52 Steve Small
And to add to that, there are a couple observational studies that try to control for some of these issues, and they found no risk with any acetaminophen use. So, really conflicting data here.
00:05:03 Steve Small
For example, a 2024 study looked at over 180,000 children exposed to acetaminophen in pregnancy. And when they accounted for some of these biases we’re talking about by using siblings as a control group, they found no difference in rates of autism and ADHD.
00:05:18 Steve Small
So, with that in mind, let’s go back to this claim here that “Acetaminophen in pregnancy causes neurologic disorders in kids, such as autism and ADHD.” The verdict is…
00:05:30
[Drumroll]
00:05:35 Steve Small
Rumor with conditions.
00:05:37 Steve Small
We don’t have evidence that acetaminophen causes autism or other neurologic conditions in kids. Instead, we’ve only seen an association.
00:05:46 Steve Small
We need randomized, placebo-controlled trials before we can say it’s a cause, because there are so many variables we need to control for.
00:05:56 Don Weinberger
Right, so viewers and listeners are… I can read their minds, are likely asking, you know, how does this change how we use acetaminophen?
00:06:05 Steve Small
Right. Well, acetaminophen is still the safest pain med option we have in pregnancy.
00:06:10 Steve Small
FDA said in their letter to physicians, quote… “clinicians should consider minimizing the use of acetaminophen during pregnancy,”
00:06:18 Steve Small
So we should only be using acetaminophen when necessary, using the lowest dose and the shortest duration needed.
00:06:26 Don Weinberger
All right, so isn’t that how we always used acetaminophen in pregnancy?
00:06:31 Steve Small
Good point, Don. I’ve worked in obstetrics most of my hospital career and this is how we honestly try to approach every medication in a pregnant patient.
00:06:40 Steve Small
So this frankly doesn’t change a thing to me when it comes to actual practice. To be totally honest.
00:06:46 Don Weinberger
Yeah, yeah. And I agree with that.
00:06:49 Don Weinberger
And we can use a multimodal approach to pain management to minimize risk to the fetus, starting off with a nondrug approach like hot or cold packs or physical therapy can minimize medication exposure in general.
00:07:02 Steve Small
Yeah. And if that doesn’t help, we can use topical products like lidocaine or menthol medications.
00:07:08 Steve Small
But we should avoid topical NSAIDs like diclofenac or methyl salicylate that you might find in muscle rubs because these can be absorbed and have fetal risks such as kidney defects and even cardiac issues.
00:07:20 Steve Small
So keep that in mind.
00:07:22 Don Weinberger
Yeah, good point, and if those don’t work, that’s where I feel we can crack out that as needed acetaminophen.
00:07:27 Steve Small
Yeah.
00:07:28 Don Weinberger
And reserve acetaminophen out our 102°F or higher. As we said earlier, higher temps in mom may harm the fetus.
00:07:37 Steve Small
Yeah. And to reiterate what we said earlier, generally steer away from oral and topical NSAIDs.
00:07:42 Steve Small
Things like ibuprofen, diclofenac and even high doses of aspirin, they have stronger evidence for adverse fetal effects we need to avoid. We’ve got the data there,
00:07:52 Don Weinberger
Yeah. And there’s lots of great info out there. We also have our great charts, Analgesics in Pregnancy and Lactation, and Topical Medications in Pregnancy and Lactation to help you compare options while balancing benefits and risks.
00:08:05 Steve Small
And a quick tip to our folks working in the hospital, don’t jump to removing acetaminophen from labor and delivery order sets. See if you need to make tweaks though.
00:08:14 Steve Small
For example, in pregnant patients, make sure the orders default to “as needed” instead of being scheduled around-the-clock.
00:08:21 Steve Small
And ensure that they have clear instructions for use to make sure we’re using them judiciously.
00:08:25 Steve Small
Also after delivery, know that it’s typically okay for moms to get scheduled acetaminophen around-the-clock because we know it helps decrease the need for opioids which have their own known set of risks that we want to avoid.
00:08:38 Don Weinberger
Right. Great call out to hospital people there. So. So with all that being said, the bottom line truth really is… acetaminophen is still the safest pain medication option in pregnant patients.
00:08:49 Don Weinberger
But it should be used like any med in pregnancy, only when needed, at the lowest dose, and shortest duration possible.
00:08:56 Steve Small
Couldn’t have said that better myself, Don, and a reminder here what we share here on our podcast is not intended to be a substitute for professional medical advice, diagnosis or treatment.
00:09:07 Steve Small
So, essentially, pregnant patients should talk with their prescriber first, before using any medication in pregnancy.
00:09:14 Don Weinberger
Yeah. Good call out and pharmacy staff are often the first point of contact when patients hear scary headlines, especially in the case with such a common OTC medication.
00:09:23 Don Weinberger
This is a great opportunity to clarify what the evidence really says and help patients make informed decisions.
00:09:29 Steve Small
And we at Rumor vs Truth are here to help you do just that. Let’s not forget that patients are bombarded by tons of conflicting info out there.
00:09:37 Steve Small
We have a great resource Discussing Medical Misinformation to help them unpack and debunk claims they may encounter on social media or from family and friends.
00:09:48 Don Weinberger
Yeah, you can also read more about the evidence behind acetaminophen pregnancy safety in our early release article in Pharmacist Letter and Prescriber Insights online.
00:09:57 Don Weinberger
We’ve linked directly to that article and all the resources we’ve mentioned in the show notes for this episode.
00:10:02 Steve Small
And in a world full of conflicting headlines, TRC Healthcare is here to help you cut through the noise. Whether you’re a pharmacist, a prescriber, or technician, our tools and articles are built to support confident, evidence-based decisions.
00:10:16 Steve Small
So, subscribe today with promo code rvt1025 at checkout to get 10% off as a listener to our show.
00:10:26 Don Weinberger
And stay tuned for our next regularly scheduled episode, Dental Dilemmas, where we will bring you multiple claims about meds affecting oral health.
00:10:33 Don Weinberger
And don’t worry, we’ll also bring back the puns.
00:10:36 Don Weinberger
Thank you for joining us on Rumor vs Truth: Quick Verdicts, your trusted source for facts where we dissect the evidence behind risky rumors and reveal clinical truths. See you next time.
Rumor vs Truth
