By Piyush Shukla

Copyright indiatimes

APOn September 22, 2025, President Trump announced that the U.S. Food and Drug Administration (FDA) would recommend limiting acetaminophen use during pregnancy to the lowest effective dose for the shortest duration necessary. He also indicated that the administration would launch a public information campaign to inform families about potential risks.

President Donald Trump on Monday urged pregnant women to avoid taking Tylenol, claiming the pain reliever could be linked to autism in children. Speaking in the Oval Office alongside Health Secretary Robert F. Kennedy Jr., Trump said the drug, known as paracetamol outside the U.S., “is no good” and should only be taken in cases of extreme fever. Trump called the rise in autism diagnoses a “horrible crisis,” vowing to take strong action. Kennedy said the Food and Drug Administration (FDA) would issue a physician notice warning of possible risks of Tylenol during pregnancy, pursue a safety label change, and launch a public health campaign. He also revealed the FDA would soon approve the decades-old cancer drug Leucovorin as a treatment option for children with autism, part of a broader pledge to launch a “massive testing and research effort” into the causes of autism.A Harvard-led review in 2023 suggested possible links between prenatal exposure and a higher risk of autism or neurodevelopmental disorders, urging caution but not a ban. Tylenol maker Kenvue pushes back Kenvue, Tylenol’s parent company, strongly rejected Trump’s claims, warning they could put mothers at risk. In a statement, the company said:Live Events “Independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.” The company added that acetaminophen remains the safest pain relief option for pregnant women. Without it, mothers might be forced to suffer through fevers—which can be dangerous for a fetus—or turn to riskier alternatives.How reliable is the new report the administration citedThe new report cited by the Trump administration, produced by the Make America Healthy Again (MAHA) Commission, has been found to be unreliable due to numerous errors and questionable citations. Investigations revealed that the report included references to scientific studies that either do not exist or were misrepresented. For example, several cited studies were confirmed by the supposed authors as never having been written or published, undermining the report’s credibility. These issues raised concerns about the thoroughness and oversight of the report’s preparation, with experts suggesting that errors might be linked to the use of generative AI technology without adequate review. An amended version was later released with corrections, yet officials maintained the substance of the report remained unchanged despite foundational citation inaccuracies. Critics emphasize that such flaws severely compromise the trustworthiness of the findings and recommendations in the report.Therefore, the report underpinning the administration’s claims about acetaminophen and autism risk appears to be poorly vetted and not sufficiently reliable as a scientific basis for policy or medical advice. This casts significant doubt on the validity of the report’s conclusions and highlights the need for rigorous, evidence-based reviews by credible scientific authorities before issuing health guidelines.What evidence exists for or against acetaminophen–autism linksThe evidence regarding a link between acetaminophen use during pregnancy and autism in children is mixed but generally does not support a causal relationship.Evidence against a causal link:The most robust and well-controlled studies find no strong association between prenatal acetaminophen exposure and autism. For example, a large Swedish study following 2.5 million children found only a very small difference in autism rates between those exposed and not exposed, and sibling comparison analysis showed no link, suggesting confounding factors explain previous associations.Several highly regarded studies, including a large 2024 study and a Japanese study using sibling controls, found no evidence that acetaminophen increases risk for autism or other neurodevelopmental disorders.Genetics appear to explain much of the observed association, as mothers with a genetic predisposition to autism or ADHD may experience more pain and thus use more acetaminophen, confounding results.Leading medical experts and organizations emphasize that evidence is inconsistent and insufficient to support changes in guidelines, with acetaminophen considered safe for pregnancy use when needed.Evidence suggesting possible association:Some observational studies and reviews report associations between prenatal acetaminophen use and higher risks of neurodevelopmental disorders including autism and ADHD, especially with prolonged or heavy use.A recent systematic review found consistent associations between acetaminophen and adverse neurodevelopment, including ADHD symptoms, but acknowledged potential confounders and called for further research.Mount Sinai researchers found biological plausibility for an effect through oxidative stress, hormone disruption, and epigenetic changes caused by acetaminophen crossing the placenta, but could not prove causality.Overall, the current consensus is that evidence is insufficient to conclude acetaminophen causes autism. Observed associations are likely influenced by confounding factors such as genetics and underlying maternal health. Health authorities recommend pregnant women use acetaminophen cautiously and only under medical advice to balance risks of untreated pain or fever. Further high-quality, controlled research is needed to clarify any risks.What do major medical organizations recommend about acetaminophen in pregnancyMajor medical organizations recommend that acetaminophen is generally safe for use during pregnancy when used appropriately, as it is considered one of the safest pain and fever relievers available for pregnant women.Key recommendations include:The American College of Obstetricians and Gynecologists (ACOG) states that acetaminophen is safe during pregnancy with no clear evidence linking its use to fetal developmental abnormalities or neurodevelopmental disorders such as autism or ADHD. ACOG emphasizes acetaminophen’s important role in managing pain and fever, which untreated can pose serious risks to both pregnant people and fetuses. They advise using the lowest effective dose for the shortest time and consulting healthcare providers about any medication use.The Society for Maternal-Fetal Medicine (SMFM) supports acetaminophen as an appropriate treatment for pain and fever in pregnancy. They note that untreated fever especially in early pregnancy can increase risks of miscarriage, birth defects, and preterm birth. SMFM highlights that current research does not establish causality between acetaminophen and neurodevelopmental disorders and reassures pregnant patients about its safety when used as directed.The Society of Obstetricians and Gynaecologists of Canada (SOGC) also affirms acetaminophen as the preferred medication for pain and fever during pregnancy, despite some reports suggesting associations with neurodevelopmental disorders, which they regard as not conclusive.Public health resources such as MotherToBaby state acetaminophen is considered by most healthcare providers as the pain reliever of choice during pregnancy due to a favorable safety profile compared to alternatives like NSAIDs, which carry higher risks.Overall, major healthcare organizations recommend cautious use—taking the smallest effective dose for the shortest duration—and consultation with healthcare professionals. They emphasize that the risks of untreated pain or fever during pregnancy outweigh theoretical risks of acetaminophen when used appropriately.Add as a Reliable and Trusted News Source Add Now!
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