November 22, 2013

By Kathryn Doyle
NEW YORK (Reuters Health) Nov 22 - Frequent use of acetaminophen in pregnancy may be
linked to poorer language skills and behavior problems in offspring, according to a new study.
As the most popular over-the-counter drug in the U.S., acetaminophen has been extensively
studied in relation to premature birth and miscarriage, with no connections found.
But its maker Johnson & Johnson periodically comes under fire for the drug's small therapeutic
index. So interest in investigating the drug persists.
The new study is the first to look at young children whose mothers took acetaminophen while
pregnant.
"Our findings suggest that (acetaminophen) might not be as harmless as we think," Ragnhild Eek
Brandlistuen said. She led the study at the School of Pharmacy at the University of Oslo in
Norway.
She and her coauthors studied 48,000 Norwegian children whose mothers answered survey
questions about their medication use at weeks 17 and 30 of pregnancy, and again six months
after giving birth.
Mothers filled out a follow-up questionnaire about their child's developmental milestones three
years later.
Close to 4% of women took acetaminophen for at least 28 days total during pregnancy.
Their children seemed to have poorer motor skills than kids whose mothers had taken the drug
fewer times or not at all. Acetaminophen-exposed kids also tended to start walking later, have
poorer communication and language skills and more behavior problems.
It's difficult to define risks for pregnant women and their children, since rigorous tests and
controlled studies of drug exposure aren't ethical, Brandlistuen said. All researchers can do is
closely observe women in the real world.
But this study, published online October 24 in the International Journal of Epidemiology,
involved a large number of women, and researchers also looked for any link to ibuprofen.
They found no development problems tied to ibuprofen.
"Long-term use of (acetaminophen) increased the risk of behavior problems by 70% at age
three," Brandlistuen said. "That is considerable."
Heavy users most often reported taking the drug for five to seven days in a row a few times
during pregnancy, she said.
"Sixty-five percent of women will take this drug at some point during pregnancy," said Ann Z.
Bauer, a doctoral candidate at the School of Health and Environment at the University of
Massachusetts Lowell.
Bauer was not involved in the new research but has studied acetaminophen and autism risk.
"Some people just pop Tylenol when they have a headache," said Dr. Martha Herbert, an autism
researcher at Massachusetts General Hospital in Boston.
The developmental problems seen in this study align with symptoms of autism spectrum
disorder, though the children had not been diagnosed at age three. Herbert has been studying the
possible link between acetaminophen and the disorder for several years.
"I don't think it's a done deal," she told Reuters Health. She doesn't like to pin "the cause of
autism" on any one thing, as many factors are likely involved.
"But for those people who wish to take precautions, this is something they can do," Herbert said,
referring to pregnant women cutting down on acetaminophen use or choosing ibuprofen instead.
In a statement to Reuters Health, Jodie Wertheim a spokesperson for Johnson & Johnson, said
the drug "has an exceptional safety profile. As the authors note in the study, there are no
prospective, randomized controlled studies demonstrating a causal link between acetaminophen
use during pregnancy and adverse effects on child development."
Wertheim continued, "We always recommend that consumers carefully read and follow label
instructions when using any over the counter medication. In addition, our label notes if pregnant
or breast-feeding, ask a health professional before use. Consumers who have medical concerns or
questions about acetaminophen should contact their health care professional."
The developmental effects Brandlistuen's team noted at age three could manifest differently or
disappear with age, but only future studies can answer that question, she said.
"Since this is the only study to show this, there is a need for further research to confirm or refute
these results before too many implications are made," she said.
SOURCE: http://bit.ly/18zAkej
Int J Epidemiol 2013.

Reuters Health Information 2013
Cite this article: Acetaminophen in Pregnancy Could Affect
Development. Medscape. Nov 22, 2013.