A recent study published in JAMA Internal Medicine indicates no link between the use of acetaminophen (Tylenol) during pregnancy and an increased risk of autism spectrum disorder (ASD) or attention-deficit hyperactivity disorder (ADHD) in children. This finding contributes to a growing body of evidence supporting the safety of acetaminophen during pregnancy.
The research team from the University of Hong Kong emphasized that paracetamol (acetaminophen) continues to be a safe and necessary option for pain and fever relief during pregnancy. They noted that alternative pain relievers, such as non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, carry well-documented risks. The authors expressed concern that avoiding paracetamol unnecessarily could lead to insufficient treatment of pain and fever, or the use of riskier alternatives, both of which could endanger the pregnancy and the developing fetus.
The study utilized electronic health records from the Hong Kong Hospital Authority, identifying pregnancies where mothers received a prescription for acetaminophen. A sibling-matched cohort was created by including mothers who had more than one child.
Researchers analyzed data from 124,333 children and found no increased risk of an ASD diagnosis associated with acetaminophen exposure during pregnancy. Similarly, a review of 97,285 children showed no elevated risk of ADHD diagnosis in those born to mothers who took acetaminophen while pregnant.
While this research reinforces the safety of acetaminophen during pregnancy when used as clinically indicated, it’s important to note that the study focused on prescription acetaminophen and did not examine the use of over-the-counter Tylenol.
The authors advised that clinicians should reassure patients that paracetamol (Tylenol) is safe when used at the lowest effective dose for the shortest necessary duration, as per clinical guidance.
Acetaminophen is a widely used medication during pregnancy for managing pain and fever, partly due to limited or contraindicated alternatives. Concerns about its potential link to autism, previously raised without new evidence, have led some pregnant women to avoid it. However, subsequent research, including the Hong Kong study, has consistently found no association between maternal acetaminophen use and an increased risk of ASD or ADHD in children. This aligns with prior findings from studies conducted in Japan, Norway, Sweden, and Taiwan.
Experts also highlighted a broader issue of underfunding research into medication safety during pregnancy. They pointed out that pregnant individuals are often excluded from clinical trials, leading to a reactive approach to generating evidence on drug safety. This means crucial data is often gathered only after medications have been widely used, making it challenging to provide timely and high-quality information for clinical decision-making.