The available evidence does not indicate a link between the use of paracetamol during pregnancy and autism, and the life-saving value of vaccines should not be questioned, a World Health Organization spokesperson stated.

“The evidence does not suggest” a connection, said Tarik Jasarevic during a press briefing in Geneva.

“We know vaccines do not cause autism. Vaccines, as I have said, save countless lives. This is scientifically proven, and these matters should not be questioned,” he added.

Donald Trump had linked autism to the use of the popular U.S. painkiller Tylenol during pregnancy. This connection was made arbitrarily and is not based on scientific data.

European Medicines Agency: Paracetamol use during pregnancy is safe

The European Medicines Agency (EMA) also announced that available evidence shows no link between paracetamol use during pregnancy and autism.

The agency emphasized that there is no new data requiring changes to existing EU recommendations on paracetamol use. EMA reiterates that paracetamol can be used during pregnancy at the lowest effective dose, for the shortest possible time, and with the least frequency.

Trump’s claim and expert reactions

Donald Trump suggested limiting paracetamol use during pregnancy due to a controversial link with autism spectrum disorder (ASD), drawing criticism from experts who maintain that paracetamol remains safe when used appropriately.

“Soon, doctors in the U.S. will be advised not to prescribe Tylenol to pregnant women,” Trump said, citing the controversial association.

Scientific evidence on the topic is inconsistent. Some studies suggested a potential link between prenatal Tylenol use and ASD, but findings are inconclusive. The manufacturer, Kenvue, has defended the drug’s safety during pregnancy, stating it remains the safest pain relief option, noting that without it, women risk using more harmful alternatives or leaving fever and pain untreated.

Key scientific findings

A 2024 JAMA study examined over 2 million children born in Sweden from 1995 to 2019, including roughly 185,000 exposed to paracetamol in utero. Comparing rates of autism, ADHD, and other neurodevelopmental disorders, researchers found no association between prenatal paracetamol use and increased risk.

A meta-analysis published in August in BMC Environmental Health reviewed 46 studies on paracetamol during pregnancy and child neurodevelopment. While some studies noted correlations with autism, authors stressed that correlation does not imply causation. They recommended cautious use: the lowest effective dose for the shortest duration under medical guidance.

Expert opinions

Dr. Peter Hotez, pediatrician and co-director of the Vaccine Development Center at Texas Children’s Hospital, said evidence linking paracetamol to autism is “not very convincing.” Environmental factors during early pregnancy may interact with genetics, but most autism cases are strongly influenced by genes.

Dr. Monique Botha, professor of social and developmental psychology at Durham University, agreed: “There is no strong or compelling evidence suggesting a causal relationship.” She emphasized that pain relief options for pregnant women are very limited, with Tylenol being among the few safe choices.

FDA notification

Trump’s announcement included a claim that the FDA would issue guidance to doctors about the “potential risk” of Tylenol during pregnancy and might update labeling. Separately, the FDA plans to evaluate treatments like leucovorin (a folinic acid derivative) for children with autism who have folate deficiencies, aiming to improve communication skills.

Meanwhile, folic acid supplements have long been recommended during pregnancy to prevent neural tube defects such as spina bifida.