New FDA Recommendation to Limit Over-the-Counter Pain Relief in Pregnancy

In mid-October, the United States Food and Drug Administration (FDA) issued a drug safety communication entitled “FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid.” In this blog post, we’ll unpack what it means for you and your pregnancy.

The first thing to know is that you’re likely not taking nonsteroidal anti-inflammatory drugs (NSAIDs) already. Examples of NSAIDs include ibuprofen, marketed as Advil and Motrin, naproxen, marketed as Aleve, and aspirin. Most care providers recommend that you avoid these drugs other than very occasional use because of possible risks to the fetus or risks to you during labor and birth. That said, some care providers do advise that infrequent use of these drugs in the first and second trimester is safe, which is different than the FDA’s new recommendation. If you’ve taken any of these drugs or any prescription NSAIDs and have concerns, talk to your doctor or midwife about them.

In issuing these new drug safety guidelines, the FDA is responding to a review of scientific evidence and 35 case reports about pregnancies affected by low amniotic fluid and babies with kidney problems. The FDA reports that these 35 cases were serious. Five newborns whose mothers took NSAIDs during pregnancy had kidney failure, accompanied in at least two of the cases by low amniotic fluid.

During the first 20 weeks of pregnancy, the gestating parent’s body makes the amniotic fluid that cushions the baby in the womb, but for the second half of pregnancy, the growing baby takes over amniotic fluid production. The baby’s kidneys are responsible for making this fluid, and the kidneys are particularly affected by NSAID use. According to the FDA, in 11 cases where amniotic fluid levels were low during pregnancy and the parent was taking NSAIDs, when they stopped taking the NSAID, the amniotic fluid levels recovered. Published research also demonstrates that NSAID use for as few as 48 hours can lower amniotic fluid levels, which usually return to normal within a week of stopping the NSAID.

In a press release that the FDA put out along with the drug safety communication, Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research, spoke to the benefits and risks of medications taken pregnancy. “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,” she said.

It’s unlikely that you would have taken NSAIDs after this point in pregnancy because, as discussed above, it was already known that these drugs could have an impact on you or baby when you’re further along or during birth. Most pregnant people are advised by their care providers to take acetaminophen (marketed as Tylenol) for pain relief instead of NSAIDs. Because acetaminophen works through a different pathway in the body, it is generally considered to be safe during pregnancy. If you are at risk for preeclampsia or gestational hypertension, it’s also possible that your care provider has suggested that you take a low-dose aspirin during pregnancy, which is also generally believed to be safe after the first trimester.

If you are experiencing any kind of pain during pregnancy, it can be tough to figure out what is safe to do to help alleviate it. Your midwife or doctor is always available as a resource—take advantage of their expertise. But you can also try things on your own, including:

Heating pad or rice sock: sometimes warmth (not too hot!) can help an aching back or head. Try relaxing as you apply heat to whatever part of your body hurts.

Water: can you go swimming or float in the tub? Water helps relieve the pressure of gravity on your joints, which can feel especially lovely as baby grows and you feel more and more pregnant. Just don’t soak or swim in water that’s too hot—pools and warm (not hot) baths are likely okay; hot tubs are not.

Stretching: doing a bit of prenatal yoga or basic stretching on your own is good way to help work out any kinks you might be feeling. It is easy to over stretch during pregnancy, thanks to the hormone relaxin, which literally relaxes your connective tissues, so just pay attention to your body and don’t overdo it.

Abby Olena
Dr. Abby Olena has a PhD in Biological Sciences from Vanderbilt University. She lives with her husband and children in North Carolina, where she writes about science and parenting, produces a conversational podcast, and teaches prenatal yoga.

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