Fri, 10/16/2020 – 15:30
FDA said Thursday that NSAID manufacturers will be required to update their labeling to warn about potential fetal risk if women take the medications at about 20 weeks or later in their pregnancy. “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 health care providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.” In its Drug Safety Communication, FDA explained the warning follows a review of the medical literature and cases reported to the agency involving 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 start producing most of the amniotic fluid, so fetal kidney problems can cause low levels of this fluid, FDA noted. For prescription NSAIDs, the prescribing information must be updated to describe the risk of kidney problems in unborn babies that result in low amniotic fluid and to recommend that NSAID use be limited between about 20-30 weeks of pregnancy due to this risk. The prescribing information already includes warnings to avoid taking NSAIDs after about 30 weeks of pregnancy, as taking these medications during this time could lead to heart issues in the unborn baby. The manufacturers of OTC NSAIDs intended for adult use must also make similar updates to the products’ Drug Facts labels.