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FDA – October 15, 2020 – According to a press announcement from the U.S. Food and Drug Administration, published a new Drug Safety Communication requiring labeling revisions for all nonsteroidal anti-inflammatory drugs (also known as NSAIDs). These label modifications will include a new warning to pregnant women alerting them of a severe kidney condition that may develop in […]
Nsaid oligohydramnios fetal injury
FDA – October 15, 2020 – According to a press announcement from the U.S. Food and Drug Administration, published a new Drug Safety Communication requiring labeling revisions for all nonsteroidal anti-inflammatory drugs (also known as NSAIDs). These label modifications will include a new warning to pregnant women alerting them of a severe kidney condition that may develop in their unborn babies when taking NSAIDs during pregnancy. The kidney condition might cause low levels of amniotic fluid (the fluid that protects the unborn baby) and an increased risk for pregnancy complications, injuries, stillbirth, or fetal death.
Nonsteroidal anti-inflammatory drugs (NSAIDs) include:
NSAIDs come in both over-the-counter (OTC) NSAIDs and prescription-only NSAIDs. These medications function by obstructing the creation of specific chemicals inside the body that create inflammation. Aspirin is classified as an NSAID. *But the FDA’s warning and recommendations do not pertain to low-dose aspirin (81 mg) usage. Low-dose aspirin is often used as an important treatment for certain conditions during pregnancy. Low-dose aspirin should only be taken by pregnant women as indicated by their doctor.
Patrizia Cavazzoni, M.D., the acting director of FDA’s Center for Drug Evaluation and Research, stated that the FDA is using “its regulatory authority to inform women and their health care providers about the risks of NSAIDs are used after around 20 weeks of pregnancy and beyond.”
As stated in the FDA’s Drug Safety Communication, the FDA’s warning to patients and medical professionals reflects the FDA’s evaluation of the cases reported to the FDA and medical literature concerning fetal low amniotic fluid levels and kidney issues connected to NSAID use during pregnancy.
An unborn baby’s kidneys start producing most of the amniotic fluid after about 20 weeks of pregnancy. If the unborn baby begins to have kidney complications after 20 weeks, the unborn baby may not produce enough amniotic fluid levels. Low levels of amniotic fluid is a medical condition called Oligohydramnios. Oligohydramnios is detectable after taking NSAIDs a few days or weeks after the pregnant mother begins taking a regular regimen of NSAID. Fortunately, Oligohydramnios typically disappears quickly after the pregnant patient discontinues taking the NSAID.
In the case of prescription NSAIDs, the FDA now requires revisions to the prescribing notice that will now warn pregnant women of the potential risks of kidney problems in unborn babies resulting in low amniotic fluid. The new labeling will also advise women to limit their use of NSAIDs between about 20 weeks to 30 weeks of pregnancy due to the risk of Oligohydramnios. Currently, there are existing warnings about taking NSAIDs after about 30 weeks of pregnancy. This warning is already included in the prescribing information since NSAIDs can lead to heart problems in unborn babies during this period of development. The FDA notice also recommends that health care providers who believe NSAID use is required within the 20 and 30 weeks of pregnancy, the medical professionals should restrict the NSAID dosage to the lowest effective dose and for the “shortest duration possible.” According to the Drug Facts labels, all over-the-counter NSAID manufacturers will update their labeling on their adult NSAID products.
If you or a loved one has lost your unborn baby to NSAID complications, contact Parker Waichman LLP for your free initial case review. Call 1-800-YOURLAWYER (1-800-968-7529) for your free consultation.
More on NSAIDs and various side effects:
NSAID Use in Pregnancy: Dangers and Legal Recourse