The U.S. Food and Drug Administration (FDA) announced that it is requiring labeling changes related to pregnancy for nonsteroidal anti-inflammatory drugs (NSAIDs), according to a press release. These changes include new labeling to explain that if women take the medications around 20 weeks or later in their pregnancy, the drugs can cause rare but serious kidney problems in the unborn baby, which can lead to low levels of amniotic fluid (the protective cushion surrounding the unborn baby) and the potential for pregnancy-related complications.
NSAIDs include medicines such as ibuprofen, naproxen, diclofenac, and celecoxib. People have taken these drugs for decades to treat pain and fever from many medical conditions. There are both prescription and over-the-counter (OTC) NSAIDs. The medications work by blocking the production of certain chemicals in the body that cause inflammation. Aspirin also is an NSAID; however, these recommendations do not apply to the use of low-dose aspirin (81 mg). Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional.
“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” said Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”
As noted in the Drug Safety Communication, the warning follows the FDA’s review of the medical literature and cases reported to the agency about low amniotic fluid levels or kidney problems in unborn babies associated with NSAID use during pregnancy.
After about 20 weeks of pregnancy, the unborn baby’s kidneys begin producing most of the amniotic fluid, so fetal kidney problems can cause low levels of this fluid. Low levels of amniotic fluid, a condition known as oligohydramnios, may be detected after taking the medicine for days or weeks, but it may be detected as soon as two days after initiation of regular NSAID use. This condition usually goes away if the pregnant woman stops taking the NSAID.
