The United States (U.S.) Food and Drug Administration (FDA) has warned that taking nonsteroidal anti-inflammatory drugs (NSAIDs) for aches and pains at 20 weeks or later in a pregnancy could raise the risk of complications. Specifically, the agency alerted that taking widely used painkillers can cause rare but serious kidney problems in the unborn baby, which could lead to low levels of amniotic fluid, increasing the potential for pregnancy complications. NSAIDs are prescription and over-the-counter (OTC) drugs that include ibuprofen, nanproxen, diclofenac and celecoxib, which are taken to treat pain and fever.
The ‘WebMD’ reported that after about 20 weeks of pregnancy, the fetus’s kidneys begin producing most of the amniotic fluid, so kidney problems can cause low levels of this protective fluid. Low levels of amniotic fluid usually result if a pregnant woman stops taking an NSAID, according to the FDA.
The FDA’s warning came after a review of 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. The agency said it had ordered that NSAID labeling warns women and their health care providers about this risk. Acting Director of FDA’s Centre for Drug Evaluation and Research, Dr. Patrizia Cavazzoni said: “It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy.” For prescription NSAIDs, the new FDA warning recommended limiting its use between about 20 weeks to 30 weeks of pregnancy. A warning to avoid taking NSAIDs after about 30 weeks of pregnancy was already included in prescribing information due to a risk of heart problems in unborn babies.
If a health care provider believes NSAIDs were necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest possible dose and shortest possible length of time, the FDA said.