Doctors in the US will soon be advised not to prescribe the painkiller Tylenol (paracetamol) to pregnant women, said US President Donald Trump, citing a controversial link between the drug and autism.
Trump announced the decision or recommendation on September 22 at the White House in the company of Health Secretary Robert F. Kennedy Jr., who had previously announced that the cause of autism will be determined by September.
The US president claims that taking paracetamol, the main ingredient in Tylenol, also known in the US as acetaminophen, is "not good" and that pregnant women should only take it in cases of very high fever.
"Taking Tylenol is not good, and that's why health authorities strongly recommend that women limit their use of Tylenol during pregnancy, unless it is medically necessary, for example, in the case of a very high fever," Trump said.
Many experts consider Tylenol one of the safest painkillers to take during pregnancy, reports Agence France-Presse.
Kenvue, the manufacturer of Tylenol, also disagrees with the findings of US authorities.
"We believe that independent, credible scientific evidence clearly shows that taking acetaminophen [paracetamol] does not cause autism."
"We strongly oppose any claims to the contrary and are deeply concerned about the health risks this poses to expectant mothers," the company said in a statement provided to the BBC.
"Autism is completely out of control... I think we have a cause," Trump told reporters late last week.
Some studies have shown a small link between taking paracetamol in pregnancy and autism, but these findings are inconsistent and do not prove that the drug causes autism.
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What is paracetamol?
Paracetamol is an over-the-counter painkiller and fever reducer.
In the US it is known as acetaminophen, and in other parts of the world as paracetamol.
Sold under various names and in forms adapted for babies and young children, it has become an indispensable medicine in households around the world for relieving pain and lowering body temperature.
Safety during pregnancy
Major medical organizations and government institutions around the world state that this drug is safe for pregnant women.
The American College of Obstetricians and Gynecologists (ACOG) said that doctors across the United States have believed for years that paracetamol (Tylenol) one of the few safe analgesics for pregnant women.
"Past research has not found clear evidence of a direct link between judicious use of acetaminophen (paracetamol) in any trimester of pregnancy and problems with fetal development," ACOG said in a statement.
British National Health Service (NHS) guidelines list paracetamol as the "first choice" painkiller for pregnant women.
"It is often used during pregnancy and does not harm the baby," the recommendations state.
Kenvue, the manufacturer of Tylenol, has said it is the safest choice for pain relief for pregnant women.
Both the company and American doctors recommend that expectant mothers consult a healthcare professional before taking any over-the-counter medication.
The Trump administration recommends that pregnant women take this medication only in case of a high fever.
A high temperature can be dangerous for both the mother and the developing baby.
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Can paracetamol cause autism?
US Secretary of Health and Human Services Robert F. Kennedy Jr. in April announced "a massive campaign of testing and research" to determine the cause of autism within five months.
However, experts have warned that determining the cause of autism, a complex syndrome that has been researched for decades, will not be simple.
The view of most researchers is that there is no single cause of autism, but rather that it is a complex combination of genetic and environmental factors.
In August, a review of research led by the dean of the Chan School of Public Health at Harvard University in the US found that children who were exposed to paracetamol during their mothers' pregnancy may have a higher risk of autism and other neurodevelopmental disorders.
The researchers said that restrictions on the drug's use should be considered, but they also noted that it is still important for lowering fever and relieving pain in pregnant women.
But another study, published in 2024, found no link between paracetamol exposure and autism.
"There is no hard evidence or convincing studies to suggest a cause-and-effect relationship," said Monique Botha, a professor of social and developmental psychology at Durham University in England.
How does paracetamol work?
Painkillers (analgesics) can be opioid or non-opioid.
Opioids, which are obtained from the poppy plant or produced in laboratories, bind to opioid receptors in the brain and stimulate the release of dopamine, a hormone associated with feelings of pleasure.
However, these medications can be highly addictive, which is why experts recommend that pain is always treated first with non-opioid medications, such as paracetamol.
Interestingly, there is still no consensus on exactly how paracetamol works.
"The mechanism of action of paracetamol is not yet fully understood," says Philip Conaghan, professor of musculoskeletal medicine at the University of Leeds, United Kingdom (UK).
"It most likely affects pain perception in the central nervous system and brain, and may also act in peripheral regions where there is inflammation."
According to the British National Health Service, paracetamol works by blocking chemical transmitters in the brain that signal pain and regulate body temperature.
It has long been theorized that paracetamol works by inhibiting an enzyme known as cyclooxygenase (COX), which helps produce prostaglandins, hormone-like substances associated with pain.
It is now believed that paracetamol has other effects as well.
For example, it is metabolized in the body into the compound AM404, which is thought to play a role in several different pain transmission pathways.
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How often can paracetamol be taken?
Experts emphasize that it is important to adhere to the recommended doses of paracetamol to ensure its safe use.
They claim that paracetamol rarely has side effects if taken in the appropriate dose and for a short time.
According to British National Health Service (NHS) guidelines, the recommended dose is one or two 500 mg tablets, up to four times within 24 hours, and a maximum of eight tablets in 24 hours.
If these doses are exceeded, severe liver damage or failure can occur, as approximately five percent of paracetamol is metabolized into a toxic substance, benzoquinone imine, known as NAPQI, the NHS adds.
Data from the US Food and Drug Administration (FDA) shows that paracetamol overdoses were the leading cause of acute liver failure in the US between 1998 and 2003.
In almost half of these cases, the overdose was accidental, as the patient inadvertently exceeded the recommended daily dose limit.
Overdoses occur frequently because acetaminophen is found in about 600 different medications, according to FDA data.
For example, a person with the flu may take several different therapies, without knowing that each of these medications contains paracetamol.
Experts also advise parents to be careful about dosing children with medication, especially when multiple people are taking care of them during the day - from daycare, grandparents, and family at home.
Effectiveness
The World Health Organization (WHO) recommends paracetamol as the first choice for treating pain and reducing mild to moderately elevated body temperature.
If it doesn't work, patients can take weak opioids, then stronger opioids, and if necessary, undergo specialist treatments.
The effectiveness of paracetamol varies depending on the type of pain.
The British Cochrane Institute, which reviews and analyzes published research, states that the drug is effective in treating acute migraines, as well as pain after childbirth and surgery.
However, for conditions such as knee arthritis, the drug's effectiveness is considered to be "modest."
For lower back pain and physical discomfort associated with cancer, paracetamol is no more effective than a placebo (a treatment without active ingredients, such as a sugar pill), the Cochrane Institute says.
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