Avoid Use of NSAID in Pregnancy, Even before 30 Weeks, warns FDA

NSAIDs are commonly used to relieve pain and reduce fevers. They include medicines such as aspirin, ibuprofen, naproxen, diclofenac, and celecoxib.

As after around 20 weeks of pregnancy, the unborn babies' kidneys produce most of the amniotic fluid, so kidney problems can lead to low levels of this fluid.

FDA wanted to communicate these recommendations more widely to educate other health care professionals and pregnant women.

So they reviewed the medical literature and cases reported to FDA for data about low amniotic fluid levels or kidney problems in unborn babies associated with NSAID use during pregnancy. The following facts were highlighted in their findings.

· Among the 35 cases of low amniotic fluid levels or kidney problems reported to FDA^* through 2017, all were serious.

· This number includes only cases submitted to FDA, so there may be additional cases.

· Two newborns who died had kidney failure and confirmed low amniotic fluid when mothers took NSAIDs while pregnant; three other newborns who died had kidney failure without confirmed low amniotic fluid when mothers took NSAIDs while pregnant.

· The low amniotic fluid levels started as early as 20 weeks of pregnancy.

· In 11 cases where low amniotic fluid levels were detected during pregnancy, the fluid volume returned to normal after the NSAID was stopped

"In most cases, the condition was reversible within 3 to 6 days after stopping the NSAID. In many reports, the condition was reversed when the NSAID was stopped, and it reappeared when the same NSAID was started again."observed the team.

Based on such serious findings, FDA recommends "health care professionals should limit prescribing NSAIDs between 20 to 30 weeks of pregnancy and avoid prescribing them after 30 weeks of pregnancy. If NSAID treatment is determined necessary, limit use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours and discontinue the NSAID if oligohydramnios is found."

For full article follow the link: FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid. [press release]. Silver Spring, MD: US Food and Drug Administration; October 15, 2020.