For Physicians. By Physicians.™
For Physicians. By Physicians.™
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
Take a post-test and get CME credits
Please log in to ObGFirst to access this page
OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
Jointly provided by
