October 18, 2022

FDA Advises Against NSAID Use in Pregnant Women at 20 Weeks and Later

The FDA is warning that use of nonsteroidal anti-inflammatory drugs (NSAIDs) around 20 weeks or later in pregnancy may cause rare but serious kidney problems in unborn babies, which can lead to low levels of amniotic fluid surrounding the baby and possible complications.

NSAIDs are commonly used to relieve pain, and they are regularly used in workers’ comp. Common NSAIDs include aspirin, ibuprofen, naproxen, diclofenac, and celecoxib. As women make up roughly half of the workforce and a significant portion of workers’ comp claims, the potential for pregnant women to be taking medications for workers’ comp claims makes this announcement noteworthy.

After around 20 weeks of pregnancy, the kidneys of unborn babies produce most of the amniotic fluid, and kidney problems can lead to low levels of this fluid. Amniotic fluid provides a protective cushion and helps the unborn babies’ lungs, digestive system, and muscles develop.

Although this safety concern is well known among certain medical specialties, it is important to communicate this recommendation more widely to educate other health care professionals and pregnant women. This issue affects all NSAIDs, including those available by prescription and those that can be bought over-the-counter (OTC) without a prescription.

The FDA plans to update the Drug Facts labels of NSAID products, as those labels currently recommend against using NSAIDs only in the last three months of pregnancy. The FDA also states that if deemed necessary by a health care professional, use of NSAIDs between 20 and 30 weeks of pregnancy should be limited to the lowest effective dose for the shortest duration.

Other medicines, such as acetaminophen, are recommended to treat pain.

For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.

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