FDA Warning: NSAID Use During Pregnancy Could Cause Complications

FDA warning

The U.S. Food and Drug Administration (FDA) has released a drug safety warning about the use of nonsteroidal anti-inflammatory drugs (NSAIDs) during pregnancy.  According to the FDA warning, using NSAIDs after the 20th week of pregnancy could cause serious kidney problems in the unborn infant.  The FDA notes that healthcare providers should already be aware of the risk of NSAIDs during pregnancy, but the agency wants to make sure that consumers are also aware of the risks.

FDA Warning about Serious Kidney Problems in Infants

According to the FDA Drug Safety Communication, taking NSAIDs after 20 weeks gestation could cause kidney problems in the developing infant.  Since the majority of amniotic fluid at that stage comes from the infant’s kidneys, kidney problems could result in low levels of amniotic fluid.  As a result, the infant could experience complications.

Low amniotic fluid is also called oligohydramnios.  This condition can develop within days of taking an NSAID, but can be detected as far out as a few weeks.  Generally, the condition goes away as soon as the mother stops taking the NSAID.  Prolonged use of NSAIDs can disrupt proper fetal development.  Furthermore, low amniotic fluid can cause disruptions in the development of the baby’s lungs, muscles and digestive system.

Now, the FDA is requiring manufacturers of over-the-counter (OTC) NSAIDs to update their labels, including adding a warning for pregnant women about the risks of serious kidney problems.  NSAID labels already contain a warning about possible heart problems in infants, but do not list kidney problems.

Healthcare providers are urged to use caution when prescribing NSAIDs during 20-30 weeks gestation.  The FDA recommends healthcare providers limit prescribing of NSAIDs between 20-30 weeks.  They should also avoid prescribing NSAIDs at all after 30 weeks gestation.  Pregnant women taking NSAIDs should carefully monitor their health and report any concerns to their healthcare team.

What is Oligohydramnios?

Oligohydramnios is the medical term for low levels of amniotic fluid.  Because amniotic fluid is the cushion that protects the infant during pregnancy, low levels of fluid can compromise the infant’s overall safety.  It can also impact labor and delivery.

According to the March of Dimes, oligohydramnios can result in the following:

First and Second Trimester:

  • Birth defects
  • Miscarriage
  • Premature birth
  • Stillbirth

Third Trimester:

  • Growth restriction
  • Umbilical cord problems
  • Difficult labor and delivery
  • Increased chance of requiring a c-section

Oligohydramnios affects around 4 out of every 100 pregnant women in the U.S.  It is most common in the second and third trimesters, and in pregnancies that extend beyond the due date.  Women who develop mild oligohydramnios may not require any specific treatment, especially if it is near their due date.  However, most women who develop Oligohydramnios require additional monitoring during the prenatal period.

Many women require additional ultrasounds and measurements to check levels of amniotic fluid.  In more severe cases, amnioinfusion may be necessary.  Amnioinfusion is a procedure where a doctor administers saline solution through into the uterus through the cervix.  Adding volume to the amniotic fluid can help reduce the risk of umbilical cord problems or the infant not getting enough nutrients.

Women whose amniotic fluid drops to a dangerous level may start the labor and delivery process earlier than they expected.

What are NSAIDS?

NSAIDs are common anti-inflammatory drugs used to treat a variety of conditions – from headaches to joint pain.  Commonly used OTC and prescription NSAIDs include:

  • Aspirin
  • Ibuprofen
  • Naproxen
  • Diclofenac
  • Clecoxib
  • Meloxicam (Mobic)
  • Etodolac

NSAIDs have been used for decades to treat all sorts of ailments.  These medications are the most commonly recommended or prescribed to treat fever and pain.  NSAIDs work by blocking production of certain chemicals that cause inflammation in the body.

Generally, the risk of side effects is low.  The most commonly reported side effects include:

  • Stomach pain
  • Dizziness
  • Nausea and vomiting
  • Diarrhea
  • Constipation
  • Heartburn

However, the FDA notes that pregnant women are an exception.  The FDA says,

“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy.  To this end, the agency is using its regulatory authority to inform women and their health care providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”

FDA Warning: How to Report Side Effects of NSAIDs

The FDA is asking women who experience adverse events from taking NSAIDs during pregnancy to report their concerns.  First, contact your healthcare provider to discuss yours and your baby’s health.  Let your healthcare provider know that you have taken NSAIDs, and document the brand, type, dosage and when you took your last dose.

Next, use the FDA MedWatch reporting program to let the FDA know about your experience.  Providing information to the FDA helps them investigate side effects and make changes that will protect consumers.  To learn more about NSAIDS from the FDA, you can also visit their webpage on Nonsteroidal Anti-Inflammatory Drugs.