Towards the end of September, the FDA issued an alert to physicians in the US that the use of acetaminophen, known as Tylenol or paracetamol, by pregnant women may be linked to an increased risk of neurological conditions, such as autism and attention-deficit/hyperactivity disorder, also known as ADHD.
It is to be noted that acetaminophen is the only over-the-counter drug approved for use to treat fevers during pregnancy, and high fevers in pregnant women can pose a risk to their children. Aspirin and ibuprofen have been documented to have adverse impacts on the fetus, as stated by the FDA.
In addition, the FDA has initiated a safety label change in the product and has asked clinicians to consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers.
The results of cohort studies, Nurses' Health Study II, published in 2019, and the Boston Birth Cohort, published in 2020, referenced by the FDA, have been found to support this association.
The Nurses' Health Study II conducted a Negative Control Exposure(NCE) analysis and evaluated 8,856 children born between 1993 and 2005 to assess whether enrolled mothers' use of acetaminophen at different times was linked to ADHD.
Out of all the children in the study, 721 or 8.1% were reported by their mothers to have been diagnosed with ADHD. NCE Analysis appeared to have a connection between acetaminophen use during pregnancy and the child being diagnosed with ADHD.
To be specific, the study evaluated the odds ratio to be 1.34, indicating the odds of ADHD in children were 34% higher if their mothers used acetaminophen during pregnancy compared to those who didn't.
The Boston Birth Cohort was done to analyze and examine the prospective associations between cord plasma acetaminophen metabolites and physician-diagnosed ADHD, ASD, and developmental disabilities in childhood.
This study tracked 996 mothers and their babies from birth as part of the Boston Birth Cohort, who enrolled between October 1998 and June 2018.
The study revealed that more acetaminophen use during pregnancy was linked to a higher risk of ADHD and ASD in the child. The risk was 2.3 to 3.5 times higher for ADHD and 1.6 to 4.1 times higher for ASD in some cases.
In addition to the research details cited by the FDA and the current precautionary measures taken by the FDA, pregnant women may consider avoiding the use of acetaminophen unless it is deemed reasonable in specific circumstances.
Meanwhile, at a press conference on September 22, President Trump commented on a relative link between acetaminophen and autism, strongly recommending pregnant women to avoid Tylenol and, if required, "tough it out" under medical guidance.
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