New Delhi: US President Donald Trump on Monday claimed that the use of acetaminophen—a widely used painkiller called Tylenol in the US and Paracetamol in India—during pregnancy could be “associated with a very increased risk of autism”.
The US President claimed that Tylenol “is no good” and that pregnant women should “fight like hell” to take it only in case of extreme fever.
Medical experts have strongly pushed back on the claims, with some calling the president’s comments dangerous.
Speaking from the Oval Office, Trump stated that the US Food and Drug Administration (FDA) would soon notify physicians to limit the recommendation of Tylenol during pregnancy unless “medically necessary”, such as for the treatment of fever, adding, “if you can’t tough it out”.
According to a CNN report, researchers broadly agree that autism spectrum disorder (ASD) is caused by a complex combination of genetic and environmental factors, and the data regarding any potential link between acetaminophen and autism remains inconclusive and evolving.
In a statement on Sunday, Tylenol manufacturer Kenvue said, “Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: Suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives.”
Trump also questioned existing childhood vaccine protocols, calling for delays in the administration of vaccines like the hepatitis B shot, which is currently given to newborns. He suggested that “too many different things are going into that baby”, though he provided no scientific evidence to support his claim.
In contrast to Trump’s strong warnings, the FDA’s current position remains more measured. In a recent letter to physicians, the agency stated that “a causal relationship has not been established” between acetaminophen use during pregnancy and autism, and acknowledged the existence of “contrary studies”.
Paracetamol usage by pregnant women under scrutiny
One of these studies is being conducted by researchers at the Icahn School of Medicine at Mount Sinai. They report that prenatal exposure to Tylenol/Paracetamol, may raise the risk of autism spectrum disorder and ADHD in children.
However, it is not based on direct research by the scientists. This study by Mount Sinai, published in BMC Environmental Health on 14 August, analysed 46 other studies with data from over 1,00,000 participants worldwide. Using the “Navigation Guide” review method, the team found that the strongest, most rigorous studies consistently showed a link between prenatal acetaminophen use and neurodevelopmental disorders in children.
Acetaminophen, taken by more than half of pregnant women globally, may cross the placenta, disrupt hormones, cause oxidative stress, and interfere with fetal brain development, the new research shows. However, this study is based on an analysis of previous research done by scientists across the world, and is not an independent analysis.
The authors still stress that the drug should only be used cautiously under medical supervision, and for limited periods. But what is more necessary is clinical research on the impact of acetaminophen on pregnant women that can more clearly establish this link.
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