There have been studies suggesting an association between acetaminophen use in pregnancy and adverse neurodevelopmental outcomes in offspring.
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.”
The SMFM has now 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.”
FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy
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