The United States Food and Drug Administration (FDA) recently announced that they would begin updating drug labeling to discourage acetaminophen (paracetamol) use during pregnancy, citing concerns about potential links to autism and attention-deficit/hyperactivity disorder (ADHD). The announcement was accompanied by a flurry of political statements, mostly portraying neurodivergence in a negative way.
As an advocate for positive acceptance of all neuro-types, I am keen to provide a more balanced view than that implied by the FDA announcement and given by political statements. So read on for my perspective.
Different research, different outcomes
The FDA statement specifically mentions two studies, the Nurses’ Health Study II and the Boston Birth Cohort, which suggest “a correlation between acetaminophen use during pregnancy and subsequent diagnosis of conditions like autism and ADHD”. The latter study specifically concludes that “our findings support previous studies regarding the association between prenatal and perinatal acetaminophen exposure and childhood neurodevelopmental risk and warrant additional investigations.”
Another study which is commonly mentioned in the media as supporting this association is the 2025 study published by BMC Environmental Health, which analyzed 46 previous studies with over 100,000 participants. The study’s conclusion supports “evidence consistent with an association between acetaminophen exposure during pregnancy and increased incidence of NDDs [neurodevelopmental disorders]”. Given the number of previous studies analyzed, there is surely statistical power to this conclusion. And the study recommends what the FDA has just announced.
As the FDA announcement recognizes, “there are contrary studies in the scientific literature”. One of those studies analyzed nearly 2.5 million children in Sweden and was published in the Journal of the American Medical Association in 2024. When comparing siblings within the same families (one sibling exposed to paracetamol in utero and another not), the associations which had been noted initially disappeared. Sibling control studies can be considered to have increased validity as they account for shared genetic and environmental factors that could confound results. However, there could be some questions about the validity of the study for populations beyond Sweden. Another “contrary study” is a clinical perspective study published in 2025 in the official journal of the American College of Obstetricians and Gynecologists which critically reviewed nine studies with original data and three meta-analyses. The conclusion was that “the current level of evidence does not warrant changes to clinical guidelines on the treatment of fever or pain in pregnancy.”
What should we conclude?
While I am not a scientist, as far as I can tell all the studies mentioned have been conducted with scientific rigor. It’s easy to find scientific studies to support one argument or the other. However, the scientific evidence is far more nuanced than the headlines suggest. The keywords to consider in the cited studies supporting the FDA’s statement are “correlation” and “association”. None of these studies explicitly indicate a causal link, they just conclude that the two phenomena occur at the same time. In other words, the studies identified no evidence that paracetamol use during pregnancy causes autism or ADHD.
Consider the following speculative hypotheses which may explain the association:
- Women who use paracetamol during pregnancy presumably have an underlying condition (why would they take the medication otherwise?) which could itself cause neurodevelopmental conditions.
- Co-occurring mental health challenges are common in neurodivergent people and may result in the use of paracetamol. Given the genetic predisposition for neurodivergence, there would obviously then be an association between paracetamol use during pregnancy and neurodevelopmental conditions in children.
- Exposure to pollutants could lead women to use paracetamol during pregnancy. Given that certain pollutants are known to increase the risk of autism, there would naturally be an association driven by such environmental factors.
The result of any of the above hypotheses materializing? Potential statistical association without causation. Of course, causation is always a possibility, which is why research should continue.
So where do we go from here?
The FDA statement recognizes that “high fevers in pregnant women can pose a risk to their children.” It also recognizes that other over-the-counter fever-reducing medications “have well-documented adverse impacts on the fetus.” So… what exactly should pregnant women who experience fever do? The possible outcome: pregnant women may avoid medication to prevent a possibly non-existent risk, while exposing themselves to real, documented dangers. Is this evidence-based or fear-based policy?
So, does it make sense to discourage paracetamol use during pregnancy? While the scientific evidence is mixed, the prevalent medical opinion is that clinical guidelines should not be changed – see for example the recent statements from the American College of Obstetricians and Gynecologists and the United Kingdom’s Medicines & Healthcare products Regulatory Agency.
I accept that regulatory agencies typically err on the side of caution. In the end, whatever is on the label of over-the-counter medication, individual medical decisions will take into account personal beliefs and circumstances. While I question the timing and content of the FDA statement, there is another dimension which I consider much more concerning. Read on to find out…
The ethical dimension
While the FDA announcement could be classified as “well-intended but misguided”, the political and mediatic framing of autism and neurodivergence in general is shocking. Around 3% of children in the United States are diagnosed autistic, and it is thought that roughly 20% of the world’s population is neurodivergent. Autistic people have now been classified as being the result of an epidemic, living with a condition that should be eradicated as soon as possible. I am going to suggest that, like me, many autistic people feel upset about this!
I am proud to be autistic. While I know I will always struggle with certain behaviors and environments, I have now learned to thrive with who I am. I recognize of course that I am fortunate to be able to live independently (I am diagnosed with Autism Spectrum Disorder Level 1, according to the American Psychiatric Association’s DSM-5). It’s undeniable that forms of autism which limit the capability to live independently present tough challenges for individuals and their families. The research into neurodevelopmental conditions should therefore continue, including further research into causes or amplifiers of autism.
However, the assumption that autism should be eradicated reflects problematic attitudes about neurodivergence and human diversity in general. Given autism’s strong genetic predisposition, it will likely always exist as part of natural human variation. So, in parallel with research into causes, let’s focus on making the lived experience of autistic people the best it can be. This means raising awareness of our real needs, removing artificial barriers created by a neurotypical world, and accepting that we all contribute to the world in our own way. It doesn’t mean stigmatizing us and fostering fear in neurotypical people.
Instead of prevention attempts based on cherry-picking the evidence boosted by misleading political statements, how about focusing on continued research into neurodevelopmental conditions and on creating inclusive societies that support all neuro-types?
PS: I recognize that my neurodivergence probably creates an inherent bias on this topic. I welcome supporting or diverging opinions – let me know by commenting!
