Naproxen, Aspirin Linked To Birth Defects

A new study has found that Naproxen is linked to birth defects and that expectant mothers taking over-the-counter (OTC) painkillers early on in their pregnancies have a slightly raised risk of giving birth to babies with some rare birth defects. The study is published in the American Journal of Obstetrics and Gynecology.

In some cases, babies born of women who took aspirin or Aleve (naproxen) experienced a three-fold likelihood of being born with no eyes or with abnormally small eyeballs, which often causes blindness, said Reuters. Also there was a three-fold risk for babies being born with amniotic band syndrome, which causes a number of malformations, including clubfoot.

It remains unclear if the painkillers caused the deformities. “These are pretty rare birth defects, so the effect is small,” said Dr. Eva Pressman, who was not involved in the research, but who studies maternal-fetal medicine at the University of Rochester Medical Center, she told Reuters Health. “A two-fold increase is still rare in the big picture,” she added. Meanwhile, Pressman said women who took NSAIDs during their first trimester shouldn’t be concerned; however, to be safe, she said she recommends avoiding NSAIDS during pregnancy, wrote Reuters.

The U.S. Centers for Disease Control and Prevention (CDC) explained that the eye defects—anophthalmia and microphthalmia—take place in one of 5,300 births in the U.S.; about one of 10,000 babies are born with amniotic band syndrome, Reuters explained. The new findings appear in the American Journal of Obstetrics and Gynecology and are based on data derived from the National Birth Defects Prevention study, which involved an interview of American women. The women were asked about the drugs they took during their first trimester of pregnancy, such as if they took common painkillers—nonsteroidal anti-inflammatory drugs or NSAIDs—that include aspirin, Aleve (naproxen) and Advil (ibuprofen), said Reuters.

The team looked at painkiller use in 15,000 women whose babies were born with birth defects and women whose babies were born without birth defects. “Of the 29 different defects we examined, we were happy that a vast majority were not tied to NSAIDs,” said study co-author Martha Werler, who studies birth defects at Boston University, according to Reuters.

Some birth defects were slightly increased in babies whose mothers said they took an NSAID when pregnant, however, said Reuters. In those cases, cleft palate risks increased by 30 – 80% and spina bifida risks increased by 60%, said Reuters. Although the research does not prove painkillers are the culprit, said Werler, they do point to the need for additional research and they are a warning sign, wrote Reuters. “Until we know more information, women should consult with their doctor to weigh risks and benefits of taking pain medication,” Werler told Reuters Health.

We recently wrote about a study that found that taking a nonaspirin NSAID in early pregnancy can double the risk of miscarriage. In addition to ibuprofen and naproxen, nonaspirin NSAIDs (non-steroidal anti-inflammatory drugs) include medications like the Cox-2 inhibitor Celebrex, which are generally used to treat inflammation, mild to moderate pain caused by headaches, arthritis, injuries and menstrual cramps, as well as fever. It is estimated that 30 million Americans take NSAIDS everyday and are among the drugs most frequently taken by pregnant women.

“Given that the use of nonaspirin NSAIDs during early pregnancy has been shown to increase the risk of major congenital malformations and that our results suggest a class effect on the risk of clinically detected spontaneous abortion, nonaspirin NSAIDs should be used with caution during pregnancy” the team from the prior research wrote.

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