FDA issued a Drug Safety Communication recommending against non-steroidal anti-inflammatory drug (NSAID) use in pregnant women at 20 weeks or later due to serious and rare kidney complications in an unborn baby. NSAIDs are used to relieve pain and reduce fevers due to short- or long-term medical conditions. Common NSAIDs include aspirin (Zorprin), diclofenac (Cambia), ibuprofen (Advil), naproxen (Aleve), and celecoxib (Celebrex). FDA based its update on FDA adverse events reporting system (FAERS) database and medical literature review.
Analysis of FAERS database found 35 cases of kidney dysfunction or decreased amniotic fluid while the mother was using NSAIDs. Five cases resulted in death due to kidney dysfunction alone (3 cases) or kidney dysfunction and low amniotic fluid (2 cases). Low amniotic fluid levels were reported as early as 20 weeks of pregnancy and in patients taking NSAIDS for as little as 48 hours. In most cases, the levels returned to baseline after 3 to 6 days following discontinuation and returned after rechallenging.
A review of literature through 2017 was performed and identified 20 patients from case reports and case series with NSAID exposure in utero and experienced kidney dysfunction following birth. Eleven cases resulted in death, with 8 cases directly attributed to neonatal kidney failure or dialysis complications. Kidney problems can lead to lower levels of amniotic fluid and complications to the babies’ lung, digestive system, and muscle development.
FDA is changing all prescribing information for NSAIDs and Drug Facts Label of over-the-counter (OTC) NSAIDS for adult use. Limit prescribing of NSAIDs between 20 – 30 weeks of pregnancy and avoid after 30 weeks. If NSAID use is necessary, prescribe the smallest effective dose for the shortest amount of time possible. Consider monitoring amniotic fluid with ultrasound imaging if NSAID use exceeds 48 hours.
As a patient, avoid NSAID use at 20 weeks of pregnancy or later. Many OTC medications contain NSAID components. Ask your pharmacist or healthcare provider for help if unsure. Notable exceptions include NSAIDs administered directly to the eye and low-dose aspirin (81 mg) if advised by a healthcare provider. Acetaminophen is an alternative to relieve pain and reduce fevers during pregnancy. Talk to your healthcare provider or pharmacist for help when deciding on an appropriate product.
Additional information on FDA safety communication and adverse event reporting are available below.
- FDA Drug Safety Communication
- Online MedWatch Reporting or call 1-800-332-1088
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