Scientists at Ben-Gurion University of the Negev have released findings from two comprehensive studies examining more than 264,000 pregnancies, concluding that widely-used pain relief medications during pregnancy do not increase the likelihood of birth defects.
The research, which appeared in PLOS Medicine and Human Reproduction Open, was spearheaded by Dr. Sharon Daniel and utilized twenty years of medical data from the siPREG (Southern Israeli Pregnancy Registry), a database that monitors health outcomes for mothers and babies.
The first investigation looked at Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen medications like Advil and Nurofen, when taken during early pregnancy. Scientists analyzed 264,858 pregnancies recorded at Soroka University Medical Center from 1998 to 2018, with over 20,000 cases involving NSAID use.
While birth abnormalities seemed somewhat more frequent initially among mothers taking NSAIDs, scientists noted that this difference vanished when they accounted for variables like fever, pain conditions, inflammatory disorders, chronic health issues, and maternal demographic factors.
“The results showed that NSAID medications are safe to use during the first trimester and are not associated with the development of congenital malformations,” Dr. Daniel stated.
The companion study examined acetaminophen, commonly known as paracetamol and available under brand names like Acamol and Tylenol. Scientists looked for possible connections between pregnancy exposure and various outcomes such as birth abnormalities, stillbirth, underweight babies, poor Apgar scores, newborn kidney problems, and early closure of the ductus arteriosus.
Medical records showed paracetamol use in 15.5% of first-trimester pregnancies and 14.1% of third-trimester pregnancies. Scientists discovered no independent connection between the drug and negative pregnancy results after controlling for medical and pregnancy-related variables.
“At first glance, raw data might suggest a slight increase in birth defects among women who took these medications,” said Dr. Daniel. “However, our analysis revealed that the risk was actually tied to the mother’s underlying condition—such as a high fever, infection, or chronic illness—rather than the painkillers themselves.”
To tackle worries about unreported non-prescription medication usage, the research team performed supplementary analyses.
“We had to ensure that ‘real-world’ habits didn’t skew our results,” said co-author Dr. Ariel Hassidim. “We demonstrated that the volume of unreported use would have to be impossibly high.”
The collaborative research team consisted of scientists from Ben-Gurion University, Soroka University Medical Center, Schneider Children’s Medical Center, and Ariel University.
