Taking paracetamol during pregnancy can cause changes in the uterus and ovaries in newborn girls.
Researchers have reported that the development of female reproductive organs may be altered by exposure to paracetamol (sold in the US under the brand name Tylenol). The scientists suggest that newborn girls whose mothers used the drug during pregnancy have smaller uteruses and ovaries than those whose mothers did not take it, according to Reuters.
It remains unclear whether the differences in infants found in the Danish study are related to potential fertility consequences later in life and during menopause. Long-term follow-up will be necessary to answer this question more definitively, said study leader Margit Bystrup Fischer of Rigshospitalet in Copenhagen.
Women who took this medication during pregnancy should not be alarmed by the results, Fisher noted. In Europe, generic versions of Tylenol are usually sold under the generic name paracetamol, while in the US, the active ingredient is known as acetaminophen.
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Kenvue, the owner of the Tylenol brand, recommended that pregnant and breastfeeding women consult a doctor before using acetaminophen. The company emphasized that this medication is one of the most studied and considered the safest pain relievers during pregnancy.
Kenvue also pointed to limitations in the study's methodology and stated that its results do not support a causal link between the drug and postnatal reproductive system development. The company's shares fell more than 3%.
Fisher's team studied 302 girls aged three months, with their mothers' drug use during pregnancy being monitored beforehand. The participants did not indicate which manufacturer's product they used.
In 92 infants, exposure to the drug began before the 17th week of pregnancy, in 67, after the 17th week, and 143 girls were born to mothers who did not take the drug.
The effects of paracetamol and its branded analogues sold in Denmark were assessed using questionnaires and urine tests that women regularly completed. The dosages were relatively low; none of the participants exceeded the recommended maximum daily dose of 4000 milligrams. The medication was most commonly taken for headaches and musculoskeletal pain.
On average, girls exposed to the drug in the womb had smaller ovaries, fewer follicles (structures containing immature eggs), smaller uterine volumes, and lower levels of reproductive hormones, the researchers reported.
Scientists explained that a woman's reproductive function is formed during the prenatal period, and girls are born with a full supply of eggs.
Previous animal studies have shown that exposure to this drug, one of the most commonly used during pregnancy, can affect the fetus's egg supply and future reproductive function, but similar data in humans has not yet been available.
US President Donald Trump has previously linked the use of Tylenol during pregnancy to autism, but the medical community and major health organizations have widely refuted these claims as lacking scientific evidence.
The study found that three-month-old girls exposed to the drug in the womb had, on average, 40% smaller ovarian volume, 13% smaller uterine volume, and 23% lower follicle count.
Children exposed early in pregnancy (before 17 weeks) had lower average levels of anti-Müllerian hormone, which is used as an indicator of egg quantity and quality.
The researchers also analyzed a separate group of 1210 girls followed from infancy to adolescence, whose mothers reported taking paracetamol during pregnancy. In this group, prenatal exposure to the drug was associated with smaller uterine size during puberty and smaller ovarian size during adolescence.
Fisher emphasized that the study cannot predict the effects on a particular woman or child: many women who took the drug during pregnancy had daughters with ovarian parameters comparable to those whose mothers did not use the drug.
Current guidelines still consider paracetamol or acetaminophen safe for pain relief and fever reduction during pregnancy. However, Fisher noted, high fever or severe pain themselves can pose a risk to the mother and fetus.
In an accompanying commentary, Christian De Geyter, a specialist in reproductive medicine at the University Hospital Basel, emphasized that the study's results are in good agreement with data previously obtained in animal experiments.
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He said that monitoring of girls exposed to this widely used drug before birth should continue until menopause. He believes that recommendations for its use during pregnancy should be revised.
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