By Jen Moulton, BSPharm, RPh, CEimpact
There’s never been more health information – and misinformation, misinterpretations, and anecdotal advice – circulating in patients’ circle of influence around acetaminophen in pregnancy. As pharmacists, we’re the go-to provider as we translate evidence, explain risk and benefit, and help patients (and clinicians) make shared decisions with the best science available at that point in time. The recent headlines about acetaminophen and neurodevelopmental outcomes in children are a stress test of that role.
On September 22, 2025, the Food and Drug Administration (FDA) announced its initiation of a label change for acetaminophen to note a possible association between prenatal use and neurodevelopmental diagnoses (autism, ADHD). The FDA emphasized that the evidence is associative, not causal, and reminded clinicians that untreated fever in pregnancy also carries risk. U.S. Food and Drug Administration
Professional societies responded. The American College of Obstetricians and Gynecologists (ACOG) affirmed that claims of causation are not supported by the totality of evidence and reiterated that acetaminophen remains an essential option for treating pain and fever in pregnancy.1 The Society for Maternal-Fetal Medicine (SMFM) similarly reaffirmed that acetaminophen is appropriate when clinically indicated.2
What the Best Studies Actually Show
On GameChangers: Clinical Updates, host Josh Kinsey and guest John Swegel, PharmD walk through the evidence pharmacists will be asked about at the counter. A few key points you can borrow when counseling:
- Observational signals exist – but so do important limitations. For example, a widely discussed 2019 study used umbilical cord biomarkers and reported a dose-response association between acetaminophen exposure at delivery and later ADHD/ASD diagnoses. But, it captured a single timepoint, had no truly unexposed group, and couldn’t exclude genetic or environmental confounding.3 JAMA Network
As Dr. Swegle notes in the episode, “we don’t have randomized trials in pregnant patients here, so we’re largely left with messy observational data,” which means residual confounding is hard to rule out.
- When you control for family factors, the association disappears. A 2024 nationwide Swedish cohort (~2.48 million children) used sibling control analyses and found no increased risk of autism, ADHD, or intellectual disability in exposed vs. unexposed siblings. This is a higher-quality design for teasing out genetic and familial confounders.
Dr. Kinsey summarizes it well in the podcast discussion, “In sibling comparisons, those elevated risks went to basically zero,” underscoring how confounding can masquerade as causation.
Bottom Line for Practice
The totality of high-quality evidence does not support a causal link between acetaminophen use in pregnancy and autism/ADHD. That aligns with current statements from ACOG and SMFM.1,2,3
Why this matters for your daily counseling
Patients are hearing “absolutist takes” online and through other sources. Here’s a patient-centered script that stays true to the evidence and the professional societies’ comments.
- Acknowledge the concern
“You’ve probably seen headlines about acetaminophen and autism. Some studies show associations, but the best-designed research that controls for family and genetics does not show increased risk.”
- Reframe risk vs. risk
Untreated fever and severe pain in pregnancy are known harms (e.g., neural tube defects, prematurity, maternal instability). Acetaminophen remains the safest OTC option for fever and pain in pregnancy. Use it only when needed, at the lowest effective dose for the shortest time—and loop in the prenatal care team for persistent symptoms.4
- Offer stepwise options
Start with non-pharmacologic strategies (rest, hydration, stretching, heat/ice, PT). For localized pain, consider topicals without salicylates (e.g., menthol, lidocaine patches) when appropriate. Avoid NSAIDs due to fetal risks, and discuss other medication options with a physician.
- Invite questions and don’t dismiss fears
“Science updates over time. If new, high-quality data change guidance, we’ll update our plan together.”
Quick evidence you can share with providers
- FDA (Sept 22, 2025): Beginning a label change to reflect a possible association, not causation. Acknowledges acetaminophen may still be appropriate and that untreated fever has risks.
- ACOG (Sept 22, 2025): No study has shown causation. Two of the highest-quality studies (one in JAMA 2024) found no significant associations when controlling for confounding. Acetaminophen remains important and safe when clinically indicated.
- SMFM (Sept 22, 2025): Reiterates acetaminophen is appropriate for pain/fever in pregnancy. Existing research does not establish a causal relationship.
- JAMA 2024 (Sweden, sibling analyses): No increased risk of autism, ADHD, or ID among exposed siblings vs. unexposed siblings.
- JAMA Psychiatry 2019 (Boston Birth Cohort, cord metabolites): Reported associations and dose – response but with key limitations (single timepoint, no truly unexposed group, potential confounding).
Put This Into Practice at Your Pharmacy
- Standard counseling line: “If you need something for fever or significant pain during pregnancy, acetaminophen is the recommended OTC choice. Use the lowest effective dose for the shortest time. If your symptoms persist or you need it often, let’s talk with your OB/midwife to check for underlying issues and align on a plan.”
- Documentation tip: Note indication, dose, duration, non-drug measures tried, and any follow-up with the patient’s prenatal provider.
- Pharmacy team discussion: Make sure every team member can explain association ≠ causation and the rationale for treating fever/pain vs. not.
Keep Learning and Get CE
Want a concise walkthrough you can share with your whole team? Listen to our GameChangers Clinical Updates episode on this topic featuring Josh Kinsey, PharmD, and John Swegel, PharmD, where they unpack the FDA announcement, the 2019 cord-blood study, and the 2024 sibling-analysis paper – and translate it into practical, patient-ready talking points. CE subscribers can claim credit after listening.
Advanced Trainings Provide Next Level Learning for Next Level Care: If you’re ready to go deeper on evidence and patient counseling, check out CEimpact’s Next Level trainings—practical, in-depth courses that move you from information to implementation so you can advance care, expand services, and grow your confidence. Advance your practice. Strengthen your care. Improve lives.
Editorial note: This article reflects the evidence and professional guidance available as of October 14, 2025. As always, CEimpact will update our education as high-quality evidence evolves.
