NSAIDs must display warning about pregnancy complications, FDA says

The FDA now requires the bottle labeling or prescribing information for nonsteroidal anti-inflammatory drugs to disclose the risks associated with their use in people who are pregnant, the agency announced Oct. 15.

NSAIDs treat pain and fever by preventing the body’s formation of certain chemicals that cause inflammation. Some NSAIDs are over-the-counter, and others require a prescription. Commonly taken NSAIDs include ibuprofen (often sold under the brand names Advil and Motrin), naproxen (often sold under the brand names Aleve and some forms of Midol) and diclofenac (often sold under the brand names Voltaren and Cambia).

The agency stipulated the labeling changes must explain that taking the medication around 20 weeks of later in a pregnancy could cause critical kidney problems in the fetus, potentially leading to low levels of amniotic fluid that could cause further complications in utero.

“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, the acting director of the FDA’s Center for Drug Evaluation and Research, said in a news release. “To this end, 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.”

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