The U.S. Food and Drug Administration (FDA) announced that it is requiring labeling changes for nonsteroidal anti-inflammatory drugs (NSAID). The October 15, 2020, announcement notified consumers and medical providers that taking NSAID around 20 weeks (and further) into a pregnancy could cause serious kidney damage in unborn babies. The drugs can also create pregnancy complications.
Consumers count on NSAIDs to relieve the most common of ailments—pain, headaches, coughs, colds, menstrual cramps, and flue symptoms. These drugs, which can be purchased over the counter (OTC) and via prescription, work by blocking the body’s production of inflammation-causing chemicals.
Many OTC brands are familiar to most consumers. They include various ibuprofen brands, like Motrin and Advil; brands of naproxen, including Aleve and Naprosyn; as well as various brands of aspirin. Prescription formulations of NSAIDs include Celecoxib (known by the brand name Celebrex); Nabumetone (known by the brand name Relafen); and diclofenac.
Although NSAIDs have for many years been approved as safe for most people, medical specialists have known for some time that the drugs present dangerous risks if taken late in a pregnancy. The FDA aims with this announcement to inform a broader audience of the risks associated with taking these medications at the 20+ week mark of a pregnancy.
NSAIDs’ Impact on Unborn Babies
While babies develop in utero, amniotic fluid provides a protective cushion that protects the fetus. This fluid also helps with the development of the baby’s muscles, lungs, and digestive system. Around 20 weeks into a pregnancy, the unborn baby’s kidneys begin to produce most of the surrounding amniotic fluid. When the baby’s kidneys do not function properly, these fluid levels can drop to dangerous levels.
This is what happens when pregnant women ingest NSAIDs around 20 weeks into their pregnancy. The baby’s kidneys become damaged, and the level of amniotic fluids surrounding the fetus drop. This condition is known as oligohydramnios. It can begin within days after the expecting mother begins taking an NSAID. For other mothers, it can take weeks for the condition to arise.
Research Confirms the Effects
The FDA keeps close watch on reports submitted via its MedWatch program. Gradually, the agency noted a trend that connected oligohydramnios and kidney problems in babies with mothers having taken some type of NSAID.
Thirty-five cases of kidney problems and low amniotic fluids in unborn babies were reported to MedWatch through 2017. Adverse incidents reported included the deaths of five newborns due to kidney failure. In cases where low amniotic fluids were reported, these conditions ceased after patients stopped taking NSAIDs. If the patient resumed taking the medications, the oligohydramnios also resumed.
Reporting NSAID Problems
In order to help the FDA further assess the dangers of NSAIDs, the agency urges patients and healthcare providers to report any adverse outcomes resulting from use of the drugs.
Furthermore, if you have taken NSAIDs, talk to your physician about replacing the drugs with some other form of treatment.