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US President Donald Trump’s latest announcement that pregnant women should not take Tylenol, which we know as paracetamol, because it is linked to the development of autism in children, has been debunked by medical professionals as a claim that is not backed by scientific evidence.
“Taking Tylenol is not good … All pregnant women should talk to their doctors about limiting the use of this medication while pregnant,” Trump was quoted as saying. As US health authorities followed this up saying a label would be put on the drug from now on, Trump also discouraged giving Tylenol to babies. He said there would be recommendations that vaccines such as the measles, mumps, rubella and varicella (MMRV) shots should be given in a delayed manner or in smaller doses although there is no evidence or research of such impacts on a child’s development milestones.
The World Health Organization (WHO), too, said that evidence of a link between the use of paracetamol during pregnancy and autism remains inconsistent. “The evidence remains inconsistent,” WHO spokesperson Tarik Jašarevic said during a press briefing in Geneva. “We also know that vaccines do not cause autism. Vaccines, as I said, save countless lives. So this is something that science has proven, and these things should not be really questioned,” he added. The European Medicines Agency (EMA) had also said that there was no new evidence that would require changes to the region’s current recommendations for the use of paracetamol during pregnancy.
It is a brand name for acetaminophen, or paracetamol, which we use as a pain reliever and a fever reducer. It is an over-the-counter medication. “It is used to alleviate headaches, muscle aches, arthritis and used to manage symptoms of colds and flu. It is one of the safest drugs to have been used during pregnancy,” says Dr Suranjit Chatterjee, senior consultant, internal medicine, Indraprastha Apollo Hospital, New Delhi.
It is a condition related to brain development of a child that affects their social behaviour, interaction and communication with the people around them. The condition also includes limited and repeated patterns of behaviour.
“There is no science-based evidence or research till date which establishes that paracetamol, when taken by pregnant women as advised by the doctor, is a causative factor of autism or that it affects the foetus. The causes of autism are multifactorial in nature and include both genetic and environmental risk factors. It cannot be attributed to a single factor,” says Dr Vivek Jain, senior director and unit head, Paediatrics, Fortis Hospital, Delhi.
In fact, he feels that overly simplistic statements about medication could undermine important discussions about prevention, early identification and intervention and treatment of autism. “Autism is a multi-faceted disorder based on genetic background, early brain development and changing social environment. All of these factors need to be researched more and that is what the medical community globally should be focussing on,” adds Dr Jain.
The latest research by Karolinska Institutet, Stockholm, last year found that acetaminophen use during pregnancy was not associated with children’s risk of autism, ADHD, or intellectual disability.
Dr Jain argues that autism is disproportionately diagnosed among children in wealthier and developed nations and cities (in this case the US) but Tylenol, or paracetamol, is consumed across the world, even in villages and small towns. “Even making concessions for under-reportage, there is no indication of association despite widespread use. This clearly illustrates that Trump’s assertion about Tylenol causing autism is unfounded,” he adds.
In fact, he wonders if the frivolity of discussions around a serious topic suppresses conversations on the real causes of autism among children. “There are stressors on the child in an urban environment. Focus on a child’s total health and wellbeing, improve their ability to communicate and strengthen familial bonds to build their confidence and abilities,” says Dr Jain.
In the absence of robust research, a link cannot be casually assigned on the basis of self-reported, multiple observational studies on associations between frequent use of Tylenol in pregnancy and effects on a child’s neurodevelopment. “As far as I know, the best controlled studies have not been able to find even the smallest risk, Besides, none of these smaller studies are even specific to autism. Then there are confounding factors. Pregnant women, who take paracetamol in pregnancy, do so because they are sick and have an underlying condition. The effect of such conditions or infections ought to be considered on the child’s development rather than just the drug itself,” says Dr Chatterjee.
During his first term, Trump had promoted hydroxychloroquine as a ‘cure’ for COVID-19 without evidence. The curbs on Tylenol is one such move, he adds.
According to the Yale School of Public Health, its associate professor Dr Zeyan Liew is currently leading an internationally collaborative project to evaluate the association between Tylenol use in pregnancy and six specific domains of neurodevelopment assessed from early to late childhood. “The project will study a range of other factors related to Tylenol use, including medical conditions, other medications or treatments taken together with Tylenol, and family history of physical and mental health outcomes,” he has been quoted as saying.
If pregnant women stop taking paracetamol to take care of their fever or pain and go untreated, then Dr Chatterjee says, it could pose risks to foetal development. “Just follow the dose recommended by a doctor and not self-medicate,” says Dr Chatterjee.
Depending on body weight, Dr Chatterjee says paracetamol use usually varies between 2 gm and 4 gms per day for adults and one should not exceed the limit. That should be spread across doses every six hours.
For newborns and infants, dosage is based on weight, not age. “The recommended limit is 10–15 mg/kg per dose, given every 6–8 hours. Do not exceed 60 mg/kg in 24 hours in newborns and infants under three months. Always use paediatric formulations (drops/syrup) and consult a doctor before dosing,” advises Dr Jain.
