There have been studies suggesting an association between acetaminophen use in pregnancy and adverse outcomes in offspring, including neurodevelopmental concerns (e.g., ADHD and autism), reproductive issues (early puberty onset) and urogenital and reproductive tract abnormalities.
A paper in Nature Reviews Endocrinology (2021) published a consensus document that states
We recommend that pregnant women should be cautioned at the beginning of pregnancy to: forego APAP unless its use is medically indicated; consult with a physician or pharmacist if they are uncertain whether use is indicated and before using on a long-term basis; and minimize exposure by using the lowest effective dose for the shortest possible time
ACOG Response
ACOG has responded to the consensus document and points out that all these studies are observational in design; there is no evidence of causation between careful use of acetaminophen and disorders of fetal development (generally categorized as multifactorial). In addition, brain development continues beyond a year of age (approximately 15 months) and therefore multiple other exposures may be relevant beyond pain medication during pregnancy. The ACOG response recognizes the importance of using medications in pregnancy ‘as needed’, but also notes that acetaminophen is considered one of the “only safe pain relievers” during pregnancy and concludes
The authors are not recommending anything counter to what is already done by obstetrician-gynecologists when prescribing acetaminophen for a given clinical condition
ACOG’s clinical guidance remains the same and physicians should not change clinical practice until definitive prospective research is done. Most importantly, patients should not be frightened away from the many benefits of acetaminophen
On January 9, 2015, the FDA stated in a Drug Safety Communication regarding possible risks of pain medicine use during pregnancy:
“Acetaminophen is a common pain reducer and fever reducer found in hundreds of medicines including those used for colds, flu, allergies, and sleep. We found all of the studies we reviewed to have potential limitations in their designs; sometimes the accumulated studies on a topic contained conflicting results that prevented us from drawing reliable conclusions. As a result, our recommendations on how pain medicines are used during pregnancy will remain the same at this time.”
SMFM Response
SMFM released a statement entitled “Prenatal Acetaminophen Use and Outcomes in Children” in response to more recent reports (retrospective) that have been published since the FDA release that looked at childhood outcomes including attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD). The SMFM concludes:
“Based on our evaluation of these studies, we believe that the weight of evidence is inconclusive regarding a possible causal relationship between acetaminophen use and neurobehavioral disorders in the offspring.”
“As with all medication use during pregnancy, communication regarding the risks versus the benefits of prescription and other-the-counter medications use should occur between patient and provider. SMFM continues to advise that acetaminophen be considered a reasonable and appropriate medication choice for the treatment of pain and/or fever during pregnancy.”
Paracetamol use during pregnancy — a call for precautionary action
ACOG Response to Consensus Statement on Paracetamol Use During Pregnancy
FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy
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