[FDA Drug Safety Communication, October 15, 2020] – The U.S. Food and Drug Administration (FDA) is warning that use of NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) around 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
Oligohydramnios is often, but not always, reversible with treatment discontinuation.
Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some post-marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
NSAIDs are commonly used to relieve pain and reduce fevers. They include medicines such as aspirin, ibuprofen, naproxen, diclofenac, and celecoxib. 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. Amniotic fluid provides a protective cushion and helps the unborn babies’ lungs, digestive system, and muscles develop.
What should pregnant women do?
Pregnant women should not use NSAIDs at 20 weeks or later unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby. Talk with your health care professional about the benefits and risks of these medicines during pregnancy before using them, especially at 20 weeks or later. Because many OTC medicines contain NSAIDs, it is important to read the medication labels to find out if the medicines contain NSAIDs. If you are unsure if a medicine contains NSAIDs, ask a pharmacist or health care professional for help.
Other medicines, such as paracetamol, are available to treat pain and fever during pregnancy. Talk to your pharmacist or health care professional for help deciding which might be best.
What should health care professionals do?
FDA recommends that 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.
As currently described in the NSAID labels, avoid prescribing NSAIDs at 30 weeks and later in pregnancy because of the additional risk of premature closure of the fetal ductus arteriosus.
The above recommendations do not apply to low-dose 81 mg aspirin prescribed for certain conditions in pregnancy.