NSAIDs

THE SAFETY OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:
Nonsteroidal anti-inflammatory drugs should be avoided during the first and third trimesters since these medications may be harmful to the developing baby. It is important to weigh the risks versus benefits of taking nonsteroidal anti-inflammatory drugs while nursing an infant.

What are nonsteroidal anti-inflammatory drugs?

Nonsteroidal anti-inflammatory drugs (NSAIDs) are used to relieve pain, fever, and inflammation. Pain and inflammation can be caused by many different factors. Types of NSAIDs that are available include aspirin, diclofenac (Cambria, Voltaren), ibuprofen (Advil), ketorolac (ReadySharp Ketorolac, Acular, Acuvail), and naproxen (Aleve). Of the available NSAIDs, aspirin, naproxen, and ibuprofen can be purchased without a prescription. 

What are nonsteroidal anti-inflammatory drugs used to treat?

Nonsteroidal anti-inflammatory drugs are used to manage symptoms of pain associated with conditions such as ankylosing spondylitis, migraine, osteoarthritis, menstrual cramps, post-surgical pain, tendonitis, bursitis, and rheumatoid arthritis in children, adolescents, and/or adults. In addition to relief of pain and fever, aspirin is used to prevent heart attacks and aspirin has many off-label uses including treatment of preeclampsia, blood clot prevention, heart disease prevention, and cancer prevention. High doses of aspirin are required to produce an anti-inflammatory effect, while low doses act as a blood thinner to prevent blood clots. 

What is pain and inflammation?

Pain is an uncomfortable feeling often caused by an injury. Injury stimulates pain receptors throughout the body that then communicate with the spinal cord and brain. Pain intensity and duration can vary among individuals as can how well a person deals with the pain. Inflammation is caused by the release of chemicals in the body that stimulate heat and swelling. Inflammation can occur due to an acute injury or it can be a chronic condition in the body. 

How do nonsteroidal anti-inflammatory drugs work?

NSAIDs inhibit enzymes in the body that are responsible for producing chemicals called prostaglandins that cause pain and inflammation. NSAIDs are most effective when taken every 4 hours for pain relief or once a day for heart disease and blood clot prevention. These medications start working quickly, and pain relief lasts a few hours, requiring frequent dosing for pain relief.

If I am taking a nonsteroidal anti-inflammatory drug, can it harm my baby?

The FDA has stated that the use of prescription nonsteroidal anti-inflammatory drugs during the first half of pregnancy may increase the risk of miscarriage. In the third trimester of pregnancy, aspirin and NSAIDs should be avoided due to an increased risk to the baby of premature closure or non-closure of the ductus arteriosus (an artery that should remain open to bypass the undeveloped lungs in utero, but close after birth to allow for oxygenation of the blood), infection/inflammation of the intestines, low amniotic fluid levels, kidney injury, and bleeding in the brain.

Evidence:

Birth Defects

The National Birth Defects Prevention Study concluded that the use of nonsteroidal anti-inflammatory drugs during early pregnancy is not a major risk factor for birth defects in babies; however, the study did report small increases in oral cleft, brain and spinal cord, limb, and eye defects with exposure to naproxen, aspirin, and ibuprofen during early pregnancy.

Miscarriage

Exposure to NSAIDs close to the time of conception has been associated with miscarriage. A study in 1055 pregnant women found that more than 1 week of prenatal nonsteroidal anti-inflammatory drug or aspirin use was associated with an increased risk of miscarriage.  A Danish study evaluated women who suffered miscarriages to determine if nonsteroidal anti-inflammatory drug use during pregnancy contributed to the miscarriage. While there was no increase in the risk of birth defects or premature delivery, the use of these medications was associated with an increased risk of miscarriage. 

Prematurity and spontaneous abortion

A recent study in pregnant women in Quebec who were exposed to nonsteroidal anti-inflammatory drugs in late pregnancy (within 3 months of delivery) found an increase in premature delivery. In the Quebec Pregnancy Registry, any non-aspirin nonsteroidal anti-inflammatory drug use during pregnancy was associated with an increased risk of spontaneous abortion (miscarriage). A study in 4500 Israeli women exposed to nonsteroidal anti-inflammatory drugs during pregnancy found no increase in risk of spontaneous abortion. The Right From the Start Study found no increase in the risk of spontaneous abortion in pregnant women exposed to over-the-counter nonsteroidal anti-inflammatory drugs during the first trimester of pregnancy. 

Other potential complications

A Norwegian study in over 6,000 pairs of women and children exposed to nonsteroidal anti-inflammatory drugs during pregnancy found no increase in the risk of birth defects; however second and third trimester use of these medications was associated with an increased risk of low birth weight, child asthma, and maternal bleeding. In Project Viva, early pregnancy use of nonsteroidal anti-inflammatory drugs for fever relief was associated with an increased risk of early childhood asthma. A study in 399 women who developed preeclampsia during pregnancy and who were treated with nonsteroidal anti-inflammatory drugs found no increased risk of persistent postpartum high blood pressure. Another study analyzed babies born with persistent pulmonary hypertension of the newborn (PPHN, defined as high blood pressure in the arteries of the lungs) and maternal use of nonsteroidal anti-inflammatory drugs during pregnancy. The study found no association between PPHN and the use of non-aspirin nonsteroidal anti-inflammatory drugs anytime during pregnancy or use of ibuprofen during the third trimester of pregnancy. An increased risk of pulmonary hypertension or high blood pressure in the arteries of the lungs has been reported in infants exposed to diclofenac. Ketorolac has been associated with PPHN in newborns as well as poor blood flow to the baby and inhibition of uterine contractions that support the recommendation to avoid ketorolac during labor and delivery. The use of nonsteroidal anti-inflammatory drugs such as naproxen to suppress premature labor has been associated with premature closure or non-closure of the ductus arteriosus (an artery that should remain open to bypass the undeveloped lungs in utero, but close after birth to allow for oxygenation of the blood), infection/inflammation of the intestines, and bleeding in the brain. 

Bottom line: Nonsteroidal anti-inflammatory drugs should be avoided during early pregnancy or close to/during labor and delivery. When taken during pregnancy, nonsteroidal anti-inflammatory drugs have been associated with complications in newborns.

If I am taking a nonsteroidal anti-inflammatory drug and become pregnant, what should I do?

If you are taking a nonsteroidal anti-inflammatory agent and become pregnant, you should contact your doctor immediately. While many studies have failed to show an increased risk of birth defects with nonsteroidal anti-inflammatory drugs, there is an increased risk of miscarriage and other potential complications including PPHN and childhood asthma. Your doctor may decide to discontinue your NSAID until after your delivery to ensure the safety of your baby.

If I am taking a nonsteroidal anti-inflammatory drug, can I safely breastfeed my baby?

There is very little data available on the effects of nonsteroidal anti-inflammatory drugs on the breastfed baby. The evidence that is available s
uggests that these medications do not cause harm to the baby. Breastfeeding is thought to be compatible with NSAID use. If nonsteroidal anti-inflammatory drugs are continued while breastfeeding, they should be used sparingly. Other medications, such as acetaminophen, may be safer. Ask your medical practitioner to help you decide.

Bottom line: It is important to weigh the risks versus benefits of continuing nonsteroidal anti-inflammatory drug therapy while nursing an infant.

If I am taking a nonsteroidal anti-inflammatory drug, will it be more difficult to get pregnant?

Nonsteroidal anti-inflammatory drugs and aspirin have been associated with decreased fertility and early pregnancy loss. [6]
 

If I am taking a nonsteroidal anti-inflammatory drug, what should I know?

Nonsteroidal anti-inflammatory drugs are not recommended in early pregnancy or close to labor and delivery. If you are planning to become pregnant, you should contact your doctor to discuss your pregnancy plans. There has been some evidence that nonsteroidal anti-inflammatory drugs can increase the risk of miscarriage and harm to the developing baby. If you need a nonsteroidal anti-inflammatory drug for pain relief during pregnant, your doctor can determine which one is the safest and the dose and duration of the medication that will minimize the risk of negative side effects.

Despite the absence of studies, nonsteroidal anti-inflammatory drugs are considered safe while breastfeeding babies. Caution is advised in women who continue breastfeeding infants while taking nonsteroidal anti-inflammatory drugs.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of NSAIDs during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert reports about the individual medications used to treat pain here,  our report about pain here, and our report about fever here.   Additional information can also be found in the resources below. 

For more information about nonsteroidal anti-inflammatory drugs during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:

UpToDate: NSAIDs: Pharmacology and mechanism of action

Merck Manuals: Overview of Pain

Johns Hopkins:  Understanding Inflammation

US Food and Drug Administration: FDA Drug Safety Communication

Read the whole report
Last Updated: 03-04-2019
General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.