By: Amanda Kastel, PharmD Candidate c\/o 2027<\/p>\n\n\n\n
On September 22, 2025, President Donald Trump and HHS Secretary Robert F. Kennedy Jr. held a press conference that sparked widespread confusion among medical professionals and the public. Roughly three minutes into the briefing, President Trump announced that the FDA would notify physicians about a \u201cvery increased risk\u201d of autism associated with acetaminophen use during pregnancy. He further urged expectant mothers not to take the medication due to this alleged risk. As current and future medical professionals, it is crucial to understand the actual evidence behind this claim \u2013 especially since it concerns the health of a particularly vulnerable population: pregnant patients.<\/p>\n\n\n\n
What the Data Says<\/strong><\/p>\n\n\n\n To make their claim, RFK and his team cited a systematic review of 46 studies.1<\/sup> Of the 46 studies included, only 8 studied an association between acetaminophen and autism spectrum disorder (ASD). It is important to note that all studies included in the review were observational \u2013 either cohort or case control designs \u2013 which means causation cannot be established. Moreover, the studies demonstrated significant heterogeneity in several key areas such as how acetaminophen exposure was defined, the timing of exposure during pregnancy, and the dose and duration of use.<\/p>\n\n\n\n Out of the 8 studies, 5 utilized self-reported maternal data2,3,4,5,6<\/sup> to define acetaminophen exposure, while others measured maternal cord blood7<\/sup>. Liew et al2<\/sup> used a retrospective recall method to collect data. In this study, 6-month postpartum mothers were asked whether they had used acetaminophen during pregnancy, when they took it, and how long they took it for. This is a weak method of data collection, as it depends entirely on maternal memory, opening the door for recall bias and potential exposure misclassification.<\/p>\n\n\n\n Ji, et al7<\/sup> determined acetaminophen exposure by measuring maternal cord blood for acetaminophen and its metabolites. While this approach eliminates recall bias, there are still significant concerns with this study design. Being that the half-life of acetaminophen is only 2-3 hours long and the cord blood is measured at birth, this method only accounts for exposure very late in pregnancy and does not account for any acetaminophen exposure early in pregnancy (1st<\/sup> and 2nd<\/sup> trimesters), a time much more crucial for fetal neurodevelopment.<\/p>\n\n\n\n These inconsistencies make it difficult to pool the data to draw a definitive, single conclusion. The authors of the systematic review acknowledge this substantial heterogeneity and therefore correctly choose not to perform a quantitative meta-analysis. While the decision makes sense, without a meta-analysis, the magnitude of association between acetaminophen use and autism cannot be quantified using statistics, resulting in a much weaker, more subjective conclusion.<\/p>\n\n\n\n A Sibling Control Analysis Refutes the Claim<\/strong><\/p>\n\n\n\n Numerous reliable studies have demonstrated that autism spectrum disorder has a genetic component attached to it.8,9 <\/sup>Therefore, in a study attempting to establish an association between ASD and acetaminophen use, it is crucial to account for this genetic confounder to ensure legitimate, unbiased results.<\/p>\n\n\n\n In the systematic review cited by RFK Jr. and his team, the only study to control for genetics was a large-scale cohort study10<\/sup> conducted in Sweden between 1995-2019. This study examined over 2.4 million births to evaluate the risk of acetaminophen exposure during pregnancy and the development of various neurodevelopmental disorders including ASD, ADHD, and intellectual disability. Acetaminophen exposure was determined through midwife interviews starting at 8-10 weeks gestation, supplemented by prescription data (2005 onward). The study accounted for numerous confounders, including genetics, using a sibling-controlled design. In the analysis where they did not account for sibling relationships, the results showed a small but statistically significant increase in the risk of autism with prenatal acetaminophen exposure (HR, 1.05 [95% CI, 1.02-1.08]; e-value,\u20091.28). However, once the genetic component was considered, the association was no longer observed (HR, 0.98 [95% CI, 0.93-1.04]), with similar results observed for ADHD and intellectual disability. These findings indicate that apparent associations between prenatal acetaminophen exposure and autism are likely attributable to genetic factors, rather than causal effects of the medication.<\/p>\n\n\n\n Clinical Implications<\/strong><\/p>\n\n\n\n Even before the September 22 press conference, it has always been clinical practice for expectant mothers to use any medication, including acetaminophen, only when necessary and at the lowest effective dose and shortest possible duration, due to the delicate biological state of pregnancy and risk-benefit considerations. Organizations such as the American College of Obstetricians and Gynecologists (ACOG), the American Academy of Pediatrics (AAP), and the World Health Organization (WHO), have emphasized this principle for decades.<\/p>\n\n\n\n During the press conference, President Trump stated there is \u201cno downside\u201d to not taking acetaminophen in pregnancy. However, prolonged or uncontrolled maternal fever can pose real risks to the fetus, including neural tube defects11<\/sup>, congenital heart defects12<\/sup>, and even neurodevelopmental disorders such as autism.13<\/sup> The language used in the press conference may generate unnecessary fear in expectant mothers, potentially leading to serious damage as a result of avoiding acetaminophen when medically needed.<\/p>\n\n\n\n Conclusion<\/strong><\/p>\n\n\n\n Based on the evidence, the medical consensus regarding acetaminophen use in pregnancy remains unchanged. Acetaminophen continues to be considered the first-line, safest option for treating maternal pain and fever. As with all medications in pregnancy, expectant mothers should consult with their doctor or pharmacist to ensure the safety of both mother and baby.<\/p>\n\n\n\n References<\/strong><\/p>\n\n\n\n By: Amanda Kastel, PharmD Candidate c\/o 2027 On September 22, 2025, President Donald Trump and HHS Secretary Robert F. Kennedy Jr. held a press conference that sparked widespread confusion among medical professionals and the public. Roughly three minutes into the briefing, President Trump announced that the FDA would notify physicians about a \u201cvery increased risk\u201d…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,5],"tags":[],"class_list":["post-4181","post","type-post","status-publish","format-standard","hentry","category-featured","category-news-politics"],"views":63,"_links":{"self":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/4181","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/comments?post=4181"}],"version-history":[{"count":2,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/4181\/revisions"}],"predecessor-version":[{"id":4183,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/4181\/revisions\/4183"}],"wp:attachment":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/media?parent=4181"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/categories?post=4181"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/tags?post=4181"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n