Is Acetaminophen During Pregnancy Safe for Children?

Acetaminophen, also referred to as paracetamol, is frequently utilized medication for alleviating pain and reducing fever. There have been theories about whether there is an increased risk of neurodevelopmental disorders in children when acetaminophen is used during pregnancy (1^✔ ✔Trusted Source
Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability

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Numerous studies by physicians and clinicians indicate that the use of acetaminophen (paracetamol) during pregnancy could potentially elevate the chances of neurodevelopmental disorders in offspring. Hence, they advise that pregnant women should avoid using acetaminophen unless there is a medical need for it.

However, these discussions could be biased due to other factors like parental health and genetics, as neurodevelopmental disorders are known to be hereditary disorders. This may confuse that the neurodevelopmental disorder is due to acetaminophen.

The other factor could be the use of other medications during pregnancy; these medications too could have caused neurodevelopmental disorders.

The earlier studies had also been constrained by small sample sizes, resulting in varying and imprecise calculations (2^✔ ✔Trusted Source
FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy

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Recently, a study was published in the journal JAMA (Journal of the American Medical Association), on 09 April, 2024, discussing the potential risk of acetaminophen on neurodevelopmental disorders in children.

The study aimed to examine the utilization of acetaminophen in pregnant women and its potential correlation with autism, ADHD (attention deficit hyperactivity disorder), and intellectual disability in children.

The study on matched full sibling pairs revealed no indication of heightened risk of autism (hazard ratio, 0.98), ADHD (hazard ratio, 0.98), or intellectual disability (hazard ratio, 1.01) linked to acetaminophen consumption.

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Details of the Study

The research study was a population-based, nationwide study, involving a large sample size of almost 2.5 million children in Sweden. The clinical diagnoses related to neurodevelopmental disorders were considered, along with sibling comparisons to address any hidden familial variables that could impact the results.

The research considered every individual live born child in Sweden from July 1, 1995, to December 31, 2019, who possessed a personal identifier that could be linked (N = 2 489 721) and was followed up until December 31, 2021.

Children were monitored from birth, utilizing the child's age as the chronological reference, until the earliest occurrence of a neurodevelopmental disorder diagnosis, death, relocation, or conclusion of the monitoring period.

The primary outcomes were neurological disorders like autism, ADHD, and intellectual disability diagnoses identified using the International Classification of Diseases (ICD) codes from the National Patient Register.

The study was conducted on two groups, and statistical data was generated. The first group included single children (without sibling control) and the other group comprised of fully matched sibling pairs (3^✔ ✔Trusted Source
Pregnancy: Does Too Much Acetaminophen Heighten Risk for Autism or ADHD?

Go to source).

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Outcome of the Study

A total of 185,909 children (7.49%) were subjected to acetaminophen while in the womb.

The data generated in this study:

1. The crude absolute risks at the age of 10 for children not exposed to acetaminophen compared to those exposed were 1.33% versus 1.53% for autism, 2.46% versus 2.87% for ADHD, and 0.70% versus 0.82% for intellectual disability.
2. In the group where sibling control was not implemented, the use of acetaminophen during pregnancy was found to be associated with a slightly increased risk of the disorders, as compared to those with no use of Acetaminophen:
• Autism (hazard ratio [HR], 1.05; risk difference [RD] at 10 years of age, 0.09%)
• ADHD (HR, 1.07; RD, 0.21%), and
• Intellectual disability (HR, 1.05; RD, 0.04%)
3. To account for unobserved factors that could influence the results, the study also examined the matched full sibling pairs. The analysis of sibling controls did not find any evidence suggesting a link between acetaminophen use during pregnancy
• Autism (HR, 0.98; risk difference [RD], 0.02%)
• ADHD (HR, 0.98; RD, −0.02%), and
• Intellectual disability (HR, 1.01; RD, 0%)

Furthermore, sibling control analyses did not reveal any indication of a dose-response pattern.

The findings of this study indicate that there is no link between the use of acetaminophen during pregnancy and the risk of autism, ADHD, or intellectual disability in children, as determined through sibling control analysis.

These results suggest that the slight rise in the likelihood of neurodevelopmental disorders in children linked to the usage of acetaminophen, as observed in statistical models without sibling control, might have been caused by factors that were not accounted for.

The findings of this investigation suggest that there is no causal link between the usage of acetaminophen during pregnancy and the occurrence of neurodevelopmental disorders.

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Constraints of the Study

Despite the strengths of this study, such as a large, nationally representative sample, thorough confounding control, and systematic, prospective recording of acetaminophen use and clinical diagnoses of neurodevelopmental disorders, there were still some constraints.

Although the diagnosis of autism condition was confirmed, the other two conditions, ADHD and intellectual disability were not authenticated

Furthermore, the assessment of exposure was not flawless. The antenatal information available in the Medical Birth Register merely indicated whether the birthing parent had used acetaminophen, without considering the specific dosage, duration, or timing.

Besides, the records of dispensing as per prescription may not accurately reflect the over-the-counter usage of acetaminophen.

US FDA Communication on Acetaminophen

The potential risks associated with the use of pain medication during pregnancy have also been thoroughly evaluated by the FDA.

The FDA recognizes the safety concerns surrounding prescription and over-the-counter (OTC) pain medications when used during pregnancy. Studies on this matter are scarce, leading the FDA to abstain from issuing precise recommendations solely relying on these studies.

It is crucial for pregnant women to seek guidance from their healthcare provider prior to consuming any prescription or over-the-counter medication. Furthermore, women who are contemplating pregnancy and are currently taking pain medication should also consult their healthcare professionals to evaluate the potential risks and advantages associated with the use of such medication. Healthcare professionals must adhere to the guidelines provided in the drug labels when prescribing pain medication to pregnant patients.

References:

1. Acetaminophen Use During Pregnancy and Children's Risk of Autism, ADHD, and Intellectual Disability - (https://pubmed.ncbi.nlm.nih.gov/38592388/)
2. FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy - (https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-has-reviewed-possible-risks-pain-medicine-use-during-pregnancy)
3. Pregnancy: Does Too Much Acetaminophen Heighten Risk for Autism or ADHD? - (https://health.clevelandclinic.org/pregnancy-does-acetaminophen-heighten-risks-for-autism-adhd)

Source-Medindia