Experts ask to investigate the impact of acetaminophen on fetal development

Covid-19 causes global increase in pregnancy problems 0:38

(CNN) - 

An international group of 13 scientists issued a statement calling on the healthcare community to carefully consider the use of acetaminophen (APAP) during pregnancy until the possible impact of the painkiller on the development of the painkiller is fully investigated. fetus in the womb.

Outside of the United States, acetaminophen is known as acetaminophen.

According to the statement published Thursday in the journal Nature Reviews Endocrinology, a growing body of research shows that "prenatal exposure to APAP may alter the development of the fetus, which could increase the risks of some neurodevelopmental, reproductive and urogenital disorders."

The statement is not a health guide, but it urges health care providers and regulators to take action.

"The authors do not recommend anything contrary to what OB-GYNs already do when they prescribe acetaminophen for a given clinical condition," said Dr. Christopher Zahn, vice president of practice activities for the American College of Obstetricians and Gynecologists (ACOG, for his acronym in English), who did not participate in the statement.

"However, as always, any medication taken during pregnancy should be used only when necessary, in moderation and after the pregnant patient has consulted with her doctor," he added.

"For medical indications"

The statement, signed by 91 scientists from Australia, Brazil, Canada, Europe, Israel, Scotland, the United Kingdom and the United States, calls for pregnant women to be warned to "stop using" paracetamol during pregnancy "unless their use is indicated by a physician. "

Even after obtaining physician approval, according to the statement, women should "minimize exposure by using the lowest effective dose for the shortest time possible."

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"There are good medical reasons for pregnant women to use APAP, after consulting doctors or pharmacists, and it is for fever and severe pain," said David Kristensen, associate professor of cell biology and physiology at the University of Copenhagen. and one of the 13 co-authors of the statement.

High fever is a known risk for multiple fetal disorders, "including neural tube defects and subsequent cardiovascular disorders," the statement states.

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However, studies show that only a third of pregnant women use acetaminophen to treat fever, the statement adds.

Instead, the most common reasons for use were "headache, muscle pain, back pain, and infection."

"The data suggests that more than 50% of women around the world use APAP during their pregnancies," Kristensen said.

"Many of these women don't see APAP as a true drug that can have potential side effects."

"It is those women who do not consider it to be a true drug that we are trying to reach and we want them to reflect for a moment on its use," he added.

Limited options

Acetaminophen has been the only pain reliever considered generally safe for use during pregnancy, leaving expectant mothers with few medical options if it is shown to be harmful to the fetus.

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"Ibuprofen has already been linked to birth defects and damage to the baby's heart and blood vessels," while high doses of aspirin have been linked to "brain bleeds and birth defects," said pediatrician Leonardo Trasande, director. Pediatric Environmental Officer at NYU Langone Health, which was not involved in creating the statement.

"The research on acetaminophen shows that this is an emerging area of ​​concern," Trasande said.

"I will always say that more research is needed to understand the mechanisms and control other exposures. But the fact is, there is substantial evidence to suggest that, at the very least, it is a danger to the fetus."

Melissa Muñoz, director of media relations for Johnson & Johnson, told CNN in an email that "the label on our TYLENOL® adult products, the active ingredient of which is acetaminophen, says: 'If you are pregnant or in lactation period, consult a health professional before use. '"

"Current evidence does not support a causal relationship between acetaminophen use during pregnancy and the risk of adverse neurological, urogenital and reproductive outcomes. Consumers with medical concerns or questions about acetaminophen should contact their healthcare professional. ".

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In their analysis of existing research on acetaminophen, the authors of the statement found that short-term use, two weeks or less, posed the least risk.

"It is among women who report longer duration use, of about two weeks or more during pregnancy, that the strongest associations are found," Kristensen said.

These results suggest that "short-term use may be less risky, giving healthcare professionals and pregnant women reassuring leeway for occasional APAP use," said Jane Houlihan, research director for Healthy Babies. Bright Futures, an alliance of nonprofit organizations that tracks babies' exposure to toxic chemicals that damage brain development.

Reproductive and neurological impact

Scientists have long studied the possible impact of acetaminophen on the developing fetus.

One reason is the similarity between APAP and a group of synthetic chemicals called phthalates, which are found in hundreds of auto, home, food, and personal care items.

"The chemical structure of acetaminophen and the way it breaks down appear to have a similar backbone to phthalates," says Trasande of New York University, who investigates the impact of chemicals on babies.

There have been laboratory studies, animal research and 29 studies on the use of acetaminophen in 220,000 mother-child pairs, according to the statement, including two studies that found acetaminophen in umbilical cord blood and in meconium, the first stool. of the baby.

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"There is now a significant body of evidence to suggest that APAP disrupts the reproductive development of animals and humans," said co-author Shanna Swan, professor of Environmental Medicine and Public Health at the Icahn Mount Sinai School of Medicine in New York. York.

"There is enough evidence to find an increased risk of undescended testes and a shortening of the ano-genital distance, which is a predictor of the subsequent decline in sperm count and fertility," Swan said.

"We also see a decline in ovarian function that has consequences for later fertility, although women have been less studied."

Twenty-six of the mother-child studies found a link between paracetamol exposure during pregnancy and certain neurodevelopmental effects, the statement noted.

"The disorders identified were primarily attention deficit hyperactivity disorder, or ADHD, and behavioral abnormalities related to ADHD, which also include autism spectrum disorder, language delays, decreased IQ, and conduct disorders. "said co-author Ann Bauer, a postdoctoral fellow and researcher at the UMass Lowell Center for Autism Research and Education.

More research is needed

ACOG's Zahn disagrees with the statement's findings.

"This consensus statement, and the studies that have been conducted in the past, do not show any clear evidence to show a direct relationship between the prudent use of acetaminophen during any trimester and fetal development problems," said Zahn of ACOG .

"Neurodevelopmental disorders, in particular, are multifactorial and very difficult to associate with a single cause," Zahn continued.

"The brain does not stop developing until at least 15 months of age, which leaves room for children to be exposed to a number of factors that could cause these problems."

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According to the statement, there are many areas that need to be studied further, which is why the group calls for a massive research effort, while warning pregnant women not to use acetaminophen without medical supervision.

"The ideal human study has not been done," Swan said, adding that more objective measures of timing of pregnancy and the length of exposure of the baby are needed.

"And then we have to follow up on these children, and look not only at their general development at birth and at one year of age, but also how their neurological development was over time. Only then would we clear up a lot of these uncertainties."

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