FDA Labeling Announcement for NSAIDS – What does this mean for pregnancy?
Recently the Food and Drug Administration (FDA) announced that it is requiring labeling
changes for nonsteroidal anti-inflammatory drugs (NSAIDs). TEF thought we might answer
some questions about what the announcement means for use in pregnancy (Found at:
Note: This does not serve as medical advice for pregnant women, merely provides information and resources for those interested in this “tox” topic in the news.
What are some examples of drugs that might be included in the NSAIDs category?
Aspirin, Ibuprofen, Naproxen, Diclofenac, Celecoxib
Why is the FDA requiring this?
Some studies in the scientific literature connect maternal exposure to NSAIDs with a rare but serious kidney problem in the unborn baby. This problem can cause low levels of amniotic fluid, which is needed, to protect and cushion the environment where the baby grows. Low levels of amniotic fluid, known as oligohydramnios, can: affect normal lung and skeletal development, lead to an early delivery, and/or fetal death.
When, during pregnancy, is taking NSAIDs a problem?
In the past, the use of NSAIDS in the third trimester was not advised as it can cause a serious heart and lung problem for the baby called premature closure of the ductus arteriosis. The concern noted in the latest FDA announcement specifies that NSAIDS should not be taken after 20 weeks of pregnancy due to the kidney problems outlined above. However, taking a drug at any time during pregnancy should be in consultation with a woman’s healthcare provider to assess risk vs. benefit.
How much of a risk is taking NSAIDs during pregnancy?
NSAIDs have been used, in the past, for safe and effective pain control and as an anti-inflammatory for various medical conditions. In pregnancy, low levels of amniotic fluid may occur with short or long-term use of NSAIDs; and, therefore use of these drugs should be done in consultation with a healthcare provider. The FDA announcement describes this risk as “rare,” but more research is needed to know how often these kidney problems might occur.
Low dose aspirin (typically 81 mg/day), which can be used for a variety of health conditions during pregnancy, has not been associated with the same risks. However, a pregnant woman should still check with a healthcare provider before using.
What if a pregnant woman needs to take NSAIDs for a medical condition?
NSAIDs use may be indicated by a healthcare provider during pregnancy, if benefits outweigh risks to mother and baby. It is important that a pregnant woman speak about the risk vs. benefits of NSAIDs in pregnancy with her healthcare provider, prior to ingesting them, especially after gestational week 20. A healthcare provider can help guide and monitor use in pregnancy for the lowest effective dose in the shortest time period, considering the medical condition.
Where can a person get more information on this topic?
Resources
Center for Better Beginnings, https://betterbeginnings.org/
Mother to Baby Fact Sheets:
Ibuprofen: https://mothertobaby.org/fact-sheets/ibuprofen-pregnancy/
Low Dose Aspirin: https://mothertobaby.org/fact-sheets/low-dose-aspirin/
Naproxen: https://mothertobaby.org/fact-sheets/naproxen/
Select References for Further Review:
Dathe, K. Hulzsch, S. Pritchard, L.W., & Schaefer C. (2019). Risk estimation of fetal adverse
effects after short-term second trimester exposure to non-steroidal anti-inflammatory
drugs; a literature review, European Journal of Clinical Pharmacology, 75 (10); 1347-
1353.https://doi.org/10.1007/s00228-019-02712-2.
Antonucci, R., Zaffanello, M., Puxeddu, E. Porcella, A. Cuzzolin, L., Dolores Pilloni, M.,
Fanos, V. (2012). Use of Non-steroidal Anti-inflammatory Drugs in Pregnancy:
Impact on the Fetus and Newborn; Current Drug Metabolism, 13 (4); 474-490.
