‘Don’t Take Tylenol’ Message Is Sharply Rebuked Outside U.S.

The Trump administration suggests that Tylenol (acetaminophen) may contribute to autism risk when used by pregnant women. President Trump repeatedly said “Don’t take Tylenol” during a news conference last week. He doubled down on the message in a Truth Social post several days ago. Outside the United States, regulatory agencies and healthcare systems reacted by reiterating that acetaminophen is the only pharmaceutical pain and fever relief option that is safe for use during pregnancy.

President Trump’s exhortations at the White House last week went well beyond words of caution. He declared “I want to say it like it is — don’t take Tylenol” and “fight like hell not to take it.” He added that pregnant women should “tough it out.” Reinforcing his message, Trump posted on Friday that pregnant women should not “use Tylenol unless absolutely necessary.” He also implored parents not to “give Tylenol to your young child for virtually any reason.”

Acetaminophen, sold in the U.S. under the brand name Tylenol, has been considered the safest painkiller for pregnant women to manage fever, headache and other pain. In many other countries it’s called paracetamol.

STAT News reported on European regulators’ de facto reaction to the U.S. news conference on Tylenol and autism, saying that “regulators have issued new statements backing the safety of [acetaminophen] use in pregnancy, effectively repudiating claims from the Trump administration that the medicine can cause autism in children.”

Though the statements don’t mention the Monday news conference, it can be inferred from the almost immediate posting of such messages that public health officials were worried that Trump’s assertions may cause unnecessary confusion for families.

The European Medicines Agency emphasized that its recommendations had not changed. It considers acetaminophen a safe way to address pain and fever in pregnancy, which are conditions that “can be dangerous to developing babies if left untreated.”

Looking at some individual countries’ health authorities, we see similar responses from around the continent.

The Dutch counterpart to the FDA, the CBG, updated its website last week to restate that paracetamol is the “safest pain medication during pregnancy.” The agency advises pregnant women to read the label and take the lowest possible dose. Furthermore, a Dutch pharmacy practice guideline website reiterated that paracetamol is recommended as first line treatment for pain and fever in children from the age of one month, contradicting what Trump wrote.

Health and Science, an independent Belgian organization dedicated to producing evidence-based clinical practice guidelines for “doctors and the public,” responded with a headline “Paracetamol does not cause autism.” A newspaper headline in Belgium said “There is no link between Dafalgan [brand name comparable to Tylenol] and autism, even though Trump claims there is.”

The National Health Service England posted an equally clear video message, while the United Kingdom’s FDA counterpart, the Medication and Healthcare products Regulatory Agency posted that “based on rigorous assessment of the best available scientific evidence” it continues to recommend paracetamol during pregnancy when used as directed.

North of the U.S. border, Health Canada updated its guidance on Sept. 23rd in the wake of the controversy. The agency “currently maintains that there is no conclusive evidence that using acetaminophen as directed during pregnancy causes autism or other neurodevelopmental disorders.” Subsequently, Health Canada states that “acetaminophen is commonly used to relieve pain and reduce fever. It has been used safely by millions of Canadians for decades, including during pregnancy and while breastfeeding.” The drug is “recommended treatment of pain or fever in pregnancy when used as directed. It should be used at the lowest effective dose for the shortest duration needed.”

Even the World Health Organization chimed in as it reissued a statement that “emphasizes that there is currently no conclusive scientific evidence confirming a possible link between autism and use of acetaminophen (also known as paracetamol) during pregnancy,”

It’s important to note that in the U.S. the FDA still states there is no causal relationship established between acetaminophen and autism or any other neurological disorder. Moreover, the agency says that therapeutic alternatives to acetaminophen have “well-documented adverse impacts.” The FDA recommends against the use of non-steroidal anti-inflammatory drugs, including ibuprofen, after week 20 of pregnancy, unless a healthcare provider specifically recommends it. It also advises not to take aspirin given the “potential for adverse effects on the fetus.”

Despite these clear messages, the agency is moving ahead with beginning the process of changing the labeling on acetaminophen to include a warning that it may cause autism and attention-deficit/hyperactivity disorder.

In doing so, the Trump administration cites a review published in Aug. of this year of 46 studies in which researchers found that when children are exposed to acetaminophen during pregnancy “they may be more likely to develop neurodevelopmental disorders,” which include autism and ADHD.

The review paper did not show that acetaminophen can directly cause autism and ADHD. Additionally, authors reported mixed findings from the 46 studies they analyzed, with a majority showing a possible connection while a minority did not. Moreover, in concluding, the authors added that “pregnant women should not stop taking medication without consulting their doctors,” noting that “untreated pain or fever can also harm the baby.”

It’s also worth mentioning that in the large-scale study of its kind published last year in the Journal of the American Medical Association, researchers found no association between pregnant women taking acetaminophen and a higher risk of autism. The study examined health records from 2.5 million Swedish children who were born between 1995 and 2019. While the collected data pointed to a very small increased risk of neurodevelopmental disorders with acetaminophen use in pregnancy, this link disappeared when researchers carried out a sibling control analysis.