Unsafe to take paracetamol during pregnancy? What new study found
What's the story
Acetaminophen, or paracetamol, once considered the safest option for pregnant women to take during a bad headache or fever, may not be so safe, according to a new study.
In a small new study, researchers at the University of Washington monitored the bloodstream levels of acetaminophen in 307 Black women during their pregnancy.
They discovered that those who used acetaminophen were more than three times as likely to have children with attention-deficit/hyperactivity disorder (ADHD).
Research findings
Study details and implications
For daughters, exposure to paracetamol in the womb was associated with over six-fold increase in risk of ADHD within the first decade of life, the study, published in Nature Mental Health, said.
"This medication was... approved decades ago, and may need reevaluation by the FDA," pediatrician Sheela Sathyanarayana from UW Medicine said.
"Acetaminophen was never evaluated for fetal exposures in relation to long-term neurodevelopmental impacts," she stressed.
Reevaluation request
Calls for reevaluation of paracetamol's safety
In recent years, several epidemiology studies have linked acetaminophen usage during pregnancy to ADHD outcomes in children.
However, some experts suggest that their findings should raise awareness rather than worry.
It's also likely that the data from the recent study won't be strong enough to convince the US Food and Drug Administration (FDA), European Medicines Agency (EMA), American College of Obstetricians and Gynecologists (ACOG), Society of Obstetricians and Gynecologists of Canada, or Society for Maternal-Fetal Medicine to change their minds.
Study
FDA declared there was inconclusive evidence
All of the agencies maintain that acetaminophen poses minimal risk when used at the lowest dose required during pregnancy.
Still, lead author Brennan Baker from Seattle Children's Research Institute believes the FDA should reconsider whether acetaminophen is safe for pregnant women.
The last time the FDA did this was in 2015, when officials concluded there was inconclusive evidence linking acetaminophen usage during pregnancy to ADHD in children.
Research
Study linked acetaminophen to ASD
In 2020, two studies measured acetaminophen levels in babies and discovered that greater amounts of the painkiller were associated with ADHD in childhood.
One of the studies also discovered a correlation with autism spectrum disorder (ASD).
"We recommend that pregnant women be cautioned at the beginning of pregnancy; forego acetaminophen unless its use is medically indicated; consult with a physician or pharmacist," a team of 91 scientists, clinicians, and public health professionals wrote in for Nature Reviews Endocrinology in 2021.