Washington, DC—A consensus statement recently published in the journal Nature Reviews Endocrinology cautions that prenatal exposure to paracetamol, sold as acetaminophen in the United States, could alter fetal development and increase the risks of neurodevelopmental, reproductive, and urogenital disorders.

However, key clinician groups in the U.S. respond that no clear evidence proves a direct relationship between the careful use of acetaminophen during any trimester and fetal-developmental issues. Neither the American College of Obstetricians & Gynecologists nor the Society for Maternal-Fetal Medicine (SMFM) recommends practice changes or curtailing the use of the painkiller in expectant mothers.

The Nature Reviews consensus statement from authors with the University of Massachusetts School of Public Health, Icahn School of Medicine at Mount Sinai, Yale Center for Perinatal, Paediatric, and Environmental Epidemiology, and international colleagues advises that paracetamol (N-acetyl-p-aminophenol [APAP]), is the active ingredient in more than 600 medications used to relieve mild-to-moderate pain and reduce fever and also is widely used by pregnant women.

The authors note that governmental agencies, including the FDA and the European Medicines Agencies, consider APAP appropriate for use during pregnancy as the labels direct.

“However, increasing experimental and epidemiological research suggests that prenatal exposure to APAP might alter fetal development, which could increase the risks of some neurodevelopmental, reproductive and urogenital disorders,” according to the consensus statement, which summarized the studies and called for “precautionary action.”

The study goes on to say, “APAP is an important medication and alternatives for treatment of high fever and severe pain are limited. 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.”

The document also states that the position is supported by 91 scientists, clinicians, and public-health professionals from across the world.

The ACOG points out, however, that “neurodevelopmental disorders, in particular, are multifactorial and very difficult to associate with a singular cause. The brain does not stop developing until at least 15 months of age, which leaves room for children to be exposed to a number of factors that could potentially lead to these issues.”

Furthermore, the authors of the ACOG statement do not recommend “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.”

The authors add, “Most importantly, patients should not be frightened away from the many benefits of acetaminophen. However, as always, any medication taken during pregnancy should be used only as needed, in moderation, and after the pregnant patient has consulted with their doctor.”

In a statement, the SMFM notes that acetaminophen “crosses the placenta relatively easily and has been reported in umbilical cord blood after maternal administration in labor. While largely considered to be safe during pregnancy, a few recently published observational studies have reported an association between prenatal acetaminophen use and potential increased risk for adverse neurological outcomes in childhood.”

The group says it created a response to put the new research into context, and 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 over-the-counter medications use should occur between patient and provider. The SMFM Publications Committee continues to advise that acetaminophen be considered a reasonable and appropriate medication choice for the treatment of pain and/or fever during pregnancy.”

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