NSAIDs During Pregnancy | RxWiki Leave a comment


(RxWiki News) Pregnancy is a very special time in a woman’s life. However, because some medications are safe during pregnancy and others are not, it can also be a confusing time.

To help clear up some of the confusion, the US Food and Drug Administration (FDA) recently issued a safety communication about the use of a common prescription and over-the-counter (OTC) fever and pain medication during pregnancy.

This warning was for nonsteroidal anti-inflammatory drugs (NSAIDs), which include ibuprofen (Advil, Motrin), naproxen (Aleve), aspirin (Excedrin), diclofenac and celecoxib (Celebrex).

However, the agency stated that these recent recommendations do not apply to low-dose aspirin (81 mg).

This new safety communication detailed the potential risks of using NSAIDs at 20 weeks or later in pregnancy.

The FDA noted that it will require new labeling for certain NSAIDs that may pose risks. The new labeling is to include and explain the risk for rare but serious kidney problems in the unborn baby if an NSAID is taken around 20 weeks or later in pregnancy. These kidney problems can lead to low levels of amniotic fluid and result in complications.

After around 20 weeks, the baby’s kidneys produce most of the amniotic fluid. And the amniotic fluid not only serves as a protective cushion for the baby, but also helps with the development of the baby’s organs. With low levels of this fluid, there is a risk for complications.

A warning about the use of NSAIDs at 30 weeks is already included on the prescription label. Now, the prescription label will include the 20-week time threshold for prescription NSAIDs.

The manufacturers of OTC NSAIDs will make similar updates to the Drug Facts labels. The Drug Facts label, typically found on the back of the box or bottle, already warns against the use of NSAIDs during the last three months of pregnancy due to the possibility of complications. However, with this recent FDA safety communication, the label will need to reflect the new recommendation about the 20-week mark.

The FDA recommended the following for women who are pregnant:

  • Do not take NSAIDs at 20 weeks or later unless specifically advised to do so by your health care professional.
  • Before taking any prescription or OTC medication or nutritional or herbal supplement, speak with your pharmacist or obstetrician. Not all medications are safe to take during pregnancy.
  • When looking at OTC medications, always look at the drug label to determine what the ingredients are. Many ingredients may not be immediately obvious. Many cold, cough, pain and insomnia medications contain NSAIDs.
  • Speak with your health care professional or pharmacist if you have questions or concerns about NSAIDs or which medicines contain them.


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