FDA Warning: Using NSAIDs During Pregnancy Could Cause Complications

If you are pregnant or planning to become pregnant, you don’t want to miss a recent FDA warning about using nonsteroidal anti-inflammatory drugs, also known as NSAIDs, during pregnancy.  NSAIDs are commonly prescribed and are readily available over-the-counter.  But before you reach for that Aspirin or Ibuprofen, talk to your doctor about the risk of possible complications or birth injuries. 

FDA Warning about NSAID Use During Pregnancy

In October 2020, the U.S.  Food and Drug Administration (FDA) released a Drug Safety Communication recommending that NSAIDs not be used by women during pregnancy.  The FDA warning says that using NSAIDS at 20 weeks or greater gestation can cause serious kidney problems in unborn babies, which can result in low levels of amniotic fluid. 

The FDA says that after 20 weeks gestation, most amniotic fluid is produced by the infant’s kidneys.  If the infant suffers kidney problems, amniotic fluid levels can diminish, which can lead to a condition called oligohydramnios. 

In a literature review, the FDA found 35 reports of kidney problems or low amniotic fluid among women taking NSAID, such as Prozac, during pregnancy.  All reports were serious in nature, and two infants died due to kidney failure.  The FDA warns that there are likely many cases of oligohydramnios due to NSAID use that are never reported. 

The FDA is now requiring changes to prescribing guidelines and labeling for NSAIDs in an effort to reduce the risk to unborn infants.  Also, the FDA is recommending the following:

• Pregnant women should avoid using NSAIDs after 20 weeks gestation
• Healthcare providers should avoid prescribing NSAIDs during pregnancy, but especially between weeks 20 and 30. 
• If it is necessary to prescribe an NSAID, healthcare providers should prescribe the lowest effective dose for the shortest duration of time. 

In addition to these recommendations, the FDA is requiring a warning be applied to NSAID labels, warning of the possible risks of taking the drugs during pregnancy.  Most NSAID drug labels already include a warning about breastfeeding, but not about taking them while pregnant. 

What is Oligohydramnios?

Oligohydramnios is the medical term for low levels of amniotic fluid.  How oligohydramnios impacts pregnancy and the health of the infant depends largely on when it develops in the pregnancy.  At different stages, amniotic fluid is an important part of infant development.  It is instrumental in the development of:

• Muscles
• Limbs
• Lungs
• Digestive system
• Breathing and swallowing mechanisms

When oligohydramnios develops, these areas of development may be disrupted.  This can result in complications, such as:

• Compressed fetal organs resulting in birth defects
• Increased risk of miscarriage or stillbirth
• Intrauterine growth restriction (IUGR)
• Preterm birth
• Umbilical cord compression (baby squeezes or lays on the cord)
• Meconium stained fluid
• Increased risk of Cesarean delivery (c-section)

Is Oligohydramnios Treatable?

Treating oligohydramnios depends on where you are in your pregnancy and yours and the infant’s overall health.  If you are not full term and have a diagnosis of oligohydramnios, your doctor will most likely monitor you closely.  He or she will likely order tests, such as non-stress and contraction tests to monitor the infant’s activity. 

If you are close to full term, your doctor may recommend that you take no action other than delivering.  If there is reason for concern, or you are not close enough to your due date to deliver, your doctor can do the following:

• Amnio-infusion – During labor, a catheter is inserted into the uterus and fluid is added to help keep your baby protected and reduce the risk of umbilical cord problems. 
• Amniocentesis – Fluid is injected into the uterus prior to delivery.  This is a temporary solution to raise amniotic fluid levels, but can be helpful.  It allows doctors to visualize fetal develop and anatomy. 
• Maternal Re-Hydration – There is evidence to suggest that oral or IV fluids administered to the mother can help increase amniotic fluid levels. 

The type of treatment available to you will depend on various factors related to the cause of oligohydramnios, as well as your health. 

What Should Pregnant Women do to Avoid the Risk of Oligohydramnios?

According to the FDA warning, pregnant women should avoid taking prescription or OTC NSAIDs unless specifically advised by their healthcare provider to do so. 

Talk to your doctor about the risks and benefits of using NSAIDs during your pregnancy.  Read the drug facts located on any drug package to see what the possible side effects are.  If you are unsure about a medication that you are taking or have been prescribed, talk to your doctor and ask questions. 

If you need pain or fever relief, try other medicines, such as Tylenol (acetaminophen).  Tylenol is not an NSAID and does not carry the same risk of lowered amniotic fluid.  Talk to your doctor or pharmacist before taking any medication while pregnant. 

How Can I Report Complications from NSAID Use?

The FDA is asking pregnant women who experience adverse events or complications while taking NSAIDs to complete a report through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.  By reporting your experience, you are helping the FDA track potentially dangerous drugs and learn more about the side effects of the drugs millions of people rely on. 

For questions or concerns about this FDA warning, you can also call the FDA at 855-543-3784, using option 4.   

Written By Sam Uribe

Sam Uribe is a researcher and writer. She lends her expertise to the team at Birth Injury Guide to provide up-to-date and relevant content that clients can count on.