The results from a few large studies on NSAIDs, including naproxen, did not show an increased chance for birth defects.
A small increased chance for heart defects has been reported in some studies looking at naproxen and other NSAIDS in early pregnancy. Other factors, such as the health condition for which naproxen was taken, could also be the cause. A small association with cleft lip and palate i. In another study where 23 pregnant women took naproxen every day to help treat lupus and arthritis, there were no birth defects seen in their children. There have been some reports that NSAID use in the 2 nd half of pregnancy might affect the kidney of the developing baby.
If there is not enough amniotic fluid called oligohydramnios other pregnancy complications, such as poor lung development and skeletal problems such as joint contractures joints can become stiff or unable to move , could happen. Oligohydramnios can also increase the chance for the need for early delivery through induction of labor or c-section. In some cases, oligohydramnios could cause fetal demise. Naproxen use later in pregnancy might also cause premature closure of the ductus arteriosus a vessel that runs from the pulmonary artery to the aorta.
Premature closure of this blood vessel can cause high blood pressure in the lungs of the developing baby called pulmonary hypertension. Talk with your healthcare provider about the benefits and risks of these medicines during pregnancy before using them.
As a result, we cannot determine how likely it is that pregnant women will experience these side effects when taking NSAIDs. You can sign up for email alerts about Drug Safety Communications on medicines or medical specialties of interest to you. We reviewed the medical literature, including case reports, randomized controlled studies, and observational studies.
Low amniotic fluid levels were detected with use of NSAIDs for varying amounts of time, ranging from 48 hours to multiple weeks. In most cases, oligohydramnios was reversible within 72 hours to 6 days following the discontinuation of the NSAID. The case reports and case series described 20 neonates exposed to NSAIDs in utero, who experienced neonatal renal dysfunction in the first days following birth. Out of 11 total deaths, eight neonates were reported to have died as a direct consequence of renal failure or due to complications from dialysis.
There were 32 cases of oligohydramnios, including eight cases of oligohydramnios and neonatal renal dysfunction, and three cases of neonatal renal dysfunction that did not report oligohydramnios. All cases reported a serious outcome. Five cases reported neonatal death, which in all cases were associated with neonatal renal failure.
All cases reported a temporal association with an NSAID and oligohydramnios or neonatal renal dysfunction, with oligohydramnios occurring as early as 20 weeks gestation. In 11 cases, a positive dechallenge was reported where the amniotic fluid volume returned to normal after the NSAID was discontinued. In all 11 cases of neonatal renal dysfunction, the neonate was born preterm before 37 weeks gestation.
Download form or call to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to FDA What safety concern is FDA announcing? What is FDA doing? What should pregnant women do? What should health care professionals do? What did FDA find? What is my risk? They are some of the most commonly used medicines for pain and fever. NSAIDs are used to treat medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu. Common side effects of NSAIDs include stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.
Additional Information for Pregnant Women. FDA is warning that using pain-relieving and fever-reducing nonsteroidal anti-inflammatory drugs NSAIDs around 20 weeks or later in pregnancy may cause kidney problems in the unborn baby, which can lead to low levels of amniotic fluid that surrounds the baby. Complications can occur with low levels of this fluid. If you are pregnant, do not use NSAIDs at 20 weeks or later in pregnancy unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby.
Talk to your health care professional or pharmacist if you have questions or concerns about NSAIDs or which medicines contain them. Additional Information for Health Care Professionals. To get relief and feel more at ease throughout your pregnancy, check out Dr. Park's recommendations for safe medications while pregnant. But note that you should avoid taking unnecessary drugs during the first trimester ; that's when fetal organs develop rapidly, making them extremely vulnerable to the potential risks of medications.
A cold compress and rest can help alleviate muscle pain and headaches during pregnancy , but if you need additional relief, your doctor may recommend acetaminophen the active ingredient in Tylenol.
Follow the dosage on the bottle you'll be okay taking Tylenol while pregnant. Other types of pain relievers—such as ibuprofen a. Motrin or Advil and naproxen a. Aleve —can trigger a decrease in amniotic fluid levels in third trimester which means less cushioning for baby and more pressure on its lifeline, the umbilical cord , says Dr.
Advil may also make a certain vessel in the baby's heart close prematurely and cause developmental issues in later stages of pregnancy. What's more, some studies suggest that taking aspirin and nonsteroidal anti-inflammatory drugs NSAIDS medications near conception or in early pregnancy may increase the risk of miscarriage and birth defects. If you're feeling a little plugged up, blame it on a surge in the hormone progesterone that slows down your smooth muscle cells so your bowel movements aren't as regular.
Or blame it on your growing uterus for pushing on your intestines! Park gives the green light for taking stool softeners and laxatives, but also try upping your fiber intake by eating more fruits and veggies and drinking plenty of fluids.
Exercise, with your doctor's approval, can also help to keep constipation at bay. If problems persist, your doctor may suggest a bulk-fiber laxative, such as Metamucil or Fiberall. Progesterone is at it again, causing heartburn by affecting your smooth muscle cells and relaxing the sphincter between your stomach and esophagus so acid comes up.
And your growing uterus is also pushing on your stomach to add to the heartburn. Learn more. He recently completed a fellowship in family practice obstetrics at Florida Hospital, Orlando.
Address correspondence to D. Ashley Hill, M. Rollins St. Reprints are not available from the authors. The authors indicate that they do not have any conflicts of interest.
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