NSAIDs May Cause Low Amniotic Fluid Risks to Unborn Babies and NSAID Manufacturers Failed to Warn Pregnant Mothers Not to Take NSAIDs at 20 Weeks and Later
U.S. FDA – January 11, 2021 – The U.S. Food and Drug Administration has updated its warning letter and its Drug Safety Communication concerning the risk of taking nonsteroidal anti- inflammatory drugs (NSAIDs) at 20 weeks of pregnancy or later.
If a pregnant woman takes an NSAID after 20 weeks of pregnancy, her unborn baby is at risk for developing a rare and potentially dangerous kidney complication. This kidney complication can lead to dangerously low levels of amniotic fluid around the unborn baby, which could cause serious complications.
NSAIDs are typically purchased over-the-counter (OTC) and are used to relieve fever, swelling, and pain. These medications are commonly referred as aspirin, celecoxib, diclofenac, ibuprofen, and naproxen. NAIDs are also used in many common cold and flu medications.
At approximately 20 weeks of pregnancy, the baby’s kidneys begin to produce the most amount of amniotic fluid throughout the entire pregnancy. At this crucial time, the baby’s kidneys must produce enough amniotic fluid to protect the unborn baby and help its lungs, muscles, and digestive system develop properly. If the unborn baby suffers kidney problems, the baby’s kidney will not produce enough amniotic fluid. Low amniotic fluid (also known as Oligohydramnios) during pregnancy can lead to severe injuries to the unborn child and cause several developmental issues.
The FDA recommends that pregnant women avoid taking NSAIDs at 20 weeks or later in pregnancy. The current NSAID prescribing information states that pregnant women should not take NSAIDs after 30 weeks of pregnancy due to heart-related risks to an unborn baby. However, the FDA states that if NSAIDs are necessary between 20 and 30 weeks of pregnancy, the dose should be limited to the lowest effective dose for the shortest duration. In addition to setting the lowest possible dose, health care professionals should perform ultrasound monitoring of amniotic fluid when NSAIDs are taken beyond a 48 hours period.
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