The Food and Drug Administration has issued a warning to both health care professionals and women on the risks of using prescription and over-the-counter NSAIDs (non-steroidal anti-inflammatory drugs) in pregnant women, starting at 20 weeks of pregnancy.
The FDA warning states that NSAID use around 20 weeks or later in pregnancy may cause serious kidney damage in unborn babies, leading to low levels of amniotic fluid and possible complications. After roughly 20 weeks of pregnancy, amniotic fluid is largely produced by the unborn baby. Fetal kidney problems can lead to low levels of this critical fluid, which is needed in the development of fetal lungs, digestive system, and muscles. The FDA is now requiring manufacturers of prescription and over-the-counter NSAIDs (such as ibuprofen, naproxen, diclofenac, celecoxib, and others) to update their warning labels immediately to include language on potential fetal risk in women using the medications 20 weeks or later in their pregnancies. Low-dose aspirin is exempt from the required label change. “Warnings to avoid taking NSAIDs after about 30 weeks of pregnancy are already included in the prescribing information because taking these medications during this time may lead to heart issues in the unborn baby,” said the FDA in their release.
The FDA based these recommendations on an evaluation of the listed cases reported to the FDA Adverse Event Reporting System [FAERS]1 database of patients having, “low amniotic fluid levels or kidney problems in unborn babies associated with NSAID use during pregnancy.” Among the 35 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.” These numbers can be inconclusive as there might be more cases that were not reported to the database.
NSAIDs are often used in spondyloarthritis as a first line of treatment or in combination with other treatments. If deemed necessary, the FDA recommends the use of the low 81-mg dose of the NSAID aspirin for certain pregnancy-related conditions at any point in pregnancy under the direction of a health care professional.
[1] FDA Adverse Event Reporting System [FAERS] database – The FDA Adverse Event Reporting System is a computerized information database designed to support the U.S. Food and Drug Administration’s post marketing safety surveillance program for all approved drug and therapeutic biologic products, to monitor for new adverse events and medication errors that might occur with these products.
References:
Center for Drug Evaluation and Research. (2020, October 5). NSAIDs may cause rare kidney problems in unborn babies. Retrieved January 12, 2021, from https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-avoiding-use-nsaids-pregnancy-20-weeks-or-later-because-they-can-result-low-amniotic
Stott, R. (2020, October 15). FDA warns of possible fetal risk linked to NSAIDs. Retrieved January 12, 202, from https://www.healio.com/news/rheumatology/20201015/fda-warns-of-possible-fetal-risk-linked-to-nsaids
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