October 23, 2020

The U.S. FDA has issued a safety communication that NSAID (nonsteroidal anti-inflammatory drug) use should be avoided in female patients who are at least 20 weeks into pregnancy. Although this is a known contraindication of NSAID use in certain medical specialties, the FDA wishes to make the information more broadly known to help educate healthcare providers and patients.

Using NSAIDs during or after Week 20 of pregnancy may cause rare, serious kidney problems in the unborn child, which can contribute to low levels of amniotic fluid in the womb. This is because the baby’s kidneys are primarily responsible for producing the amniotic fluid beginning around Week 20 of pregnancy. Amniotic fluid helps protect the baby in the womb and supports development of the lungs, digestive system, and muscles.

The safety communication applies to all NSAIDs, both prescription and over-the-count (OTC) products. In addition, the FDA is requiring updates to the prescribing information (PI) on all prescription NSAID products as well as to the Drug Facts on the labels of all OTC NSAIDs. Prescription NSAID PI, which already recommended against using NSAIDs at or beyond Week 30 due to potential for heart problems in the unborn child, will now recommend avoiding NSAIDs in pregnant women at 20 weeks or later in pregnancy. For OTC NSAIDs, the Drug Facts label will also reflect that they should not be used at or beyond Week 20 of pregnancy, a change from labeling that already advised against using the products during the final three months of pregnancy due to the potential for harm to the unborn child or complications during delivery.

According to the FDA, a low 81mg dose of aspirin is excepted from the above recommendations in certain instances, when taken under the direction of a healthcare professional to treat certain pregnancy-related conditions at any point during pregnancy.

The full safety communication can be found on the FDA’s website.

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