The maker of Tylenol has pushed back against the Trump administration’s claim that the painkiller causes autism, branding it ‘dangerous’ and insisting its drug remains the safest option for pain and fever relief in pregnant women.
In a press conference later today, the administration is set to state that taking acetaminophen, the active ingredient in Tylenol, during pregnancy raises the risk of a child developing autism.
Slamming the claim, a spokeswoman for Kenvue, the company that makes Tylenol, said: ‘We believe 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.’
She added: ‘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.
‘The facts are that over a decade of rigorous research, endorsed by leading medical professionals and global health regulators, confirms there is no credible evidence linking acetaminophen to autism.
‘We stand with the many public health and medical professionals who have reviewed this science and agree. We will continue to explore all options to protect the health interests of the American women and children.’
The Trump administration and Health and Human Services Secretary Robert F Kennedy Jr have made it a top priority to tackle America’s rising autism rates, with one in 31 children now estimated to have the condition compared to one in 150 children in 2000.
Acetaminophen, brand name Tylenol, is under fire amid claims that the drug, when taken during pregnancy, may raise the risk of a child developing autism
Donald Trump teased the announcement this week, saying in a detour while speaking at Charlie Kirk’s memorial service, ‘I think we found an answer to autism’.
Experts say the increase is largely due to a loosening of the definition of autism and because doctors have become better at detecting the condition.
But others, including RFK Jr, have suggested toxins in the environment, older parents or maternal obesity could be behind the rise.
Acetaminophen is widely used by pregnant women, with about 60 percent taking the drug, to reduce fevers and pain that could harm both mother and baby.
Acetaminophen, called paracetamol in the UK, is found in Tylenol and a number of other medications, including over-the-counter cold and flu drugs such as DayQuil and NyQuil and sleep aids such as Excedrin PM.
The drug is considered to be among the only safe and doctor-approved pain and fever reliever for use in pregnant women.
However, several studies have previously linked acetaminophen, available over-the-counter, to higher rates of autism and attention deficit hyperactivity disorder (ADHD), including a major paper involving 100,000 people from Mount Sinai this year, but results have often been inconsistent.
Other studies have shown, however, that there is no or an inconclusive relationship between the drug and autism.
Major medical organizations, including the American College of Obstetricians and Gynecologists, say it is safe for pregnant women to take the drug, although they recommend consulting with a doctor.
Kenvue’s statement today came as its stock dropped seven percent, with a share now worth about $17 compared to $18.60 before the reports of Trump’s announcement.
Experts in the medical field have already criticized the Trump administration’s pending announcement, saying there is ‘no robust evidence’ to back the claim and warning that pain relief for pregnant women is ‘woefully lacking’.
Tylenol is widely used by pregnant women, with estimates suggesting 60 percent take the drug during their pregnancy to help reduce fevers and pain (stock image)
Dr Monique Botha, a developmental psychologist at Durham University in the UK, said in a statement released by the Science Media Center: ‘There is no robust evidence or convincing studies to suggest there is any causal relationship and any conclusions being drawn to the contrary are often motivated, under-evidenced, and unsupported by the most robust methods to answering this question.
‘I am exceptionally confident in saying that no relationship exists.’
She added: ‘Pain relief for pregnant women is woefully lacking and paracetamol is a much safer pain relief option during pregnancy than basically any other alternative and we need to take pain seriously for women including whilst pregnant.’
Dr Hannah Kirk, a developmental psychologist at Monash University, also in the UK, added in the same release: ‘No study has shown that paracetamol [acetaminophen] causes autism.
‘Some studies have reported an association between paracetamol [acetaminophen] use and autism, while others have not. Importantly, association does not mean causation.’
It isn’t clear how acetaminophen may raise the risk of a child developing autism, but scientists say it could impact how the fetal brain develops.
Pregnant women are already advised not to take over-the-counter painkillers including ibuprofen, brand name Advil or Motrin, over fears it raises the risk of miscarriages and low birthweight.
Allegations that acetaminophen causes autism were raised again in August this year when a comprehensive review by scientists from Mount Sinai and Harvard’s School of Public Health revealed the ‘strongest evidence so far’ of a link.
For the study, the scientists analyzed data from 46 separate studies involving more than 100,000 participants.
Kenvue, the manufacturer of Tylenol, saw its stock price collapse today amid the reports
They collected detailed data on when acetaminophen was taken, whether it was in the first, second or third trimester or through the whole pregnancy, and linked it to the mothers’ medical records.
Writing in the journal Environmental Health, they concluded: ‘Ultimately, the obtained scores suggest strong evidence of a likely relationship between prenatal acetaminophen use and increased risk of ADHD in children.
‘This includes high-quality studies that provide very strong evidence of an association and studies that provide strong evidence of an association.’
Revealing the study, the scientists urged mothers-to-be to use acetaminophen sparingly, recommending only ‘the lowest effective dose for the shortest possible time’.
The paper is observational, however, and only detects an association, but cannot confirm whether this is due to Tylenol use or other factors.
President Donald Trump revealed the administration’s plans in an aside during his tribute at Charlie Kirk’s memorial service on Sunday.
‘I think you’re going to find it to be amazing. I think we found an answer to autism,’ he said, adding that his administration ‘won’t let it happen anymore’.
He also teased the announcement Saturday at an event hosted by the American Cornerstone Institute, a conservative think-tank.
He said at the time: ‘I think it’s going to be a very important announcement. I think it’s going to be one of the most important things that we will do.’
