By Robert Preidt
The U.S. Food and Drug Administration warned on Thursday that taking these widely used painkillers — which include Advil, Motrin, Aleve and Celebrex — at 20 weeks or later in a pregnancy could raise the risk of complications.
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 resolve if a pregnant woman stops taking an NSAID, according to the FDA.
The agency said it has ordered that NSAID labeling warns women and their health care providers about this risk.
NSAIDs are prescription and over-the-counter (OTC) drugs that include ibuprofen, naproxen, diclofenac and celecoxib, which are taken to treat pain and fever. Aspirin is also an NSAID, but the new labeling rules don’t apply to the use of low-dose aspirin.
“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Dr. Patrizia Cavazzoni, acting director of FDA’s Center for Drug Evaluation and Research, said in an agency news release.
One ob-gyn noted that over-the-counter NSAIDs may pose the greatest danger to pregnant women.
“Many female patients use ibuprofen regularly for headaches and menstrual cramps,” said Dr. Jennifer Wu, from Lenox Hill Hospital in New York City. “It is very important that these patients realize that ibuprofen and other NSAIDs pose a unique danger to pregnant patients.
“The majority of patients get these medications over the counter and may even be using them at the prescription-strength level,” Wu added. “While many prescription drugs come with the oversight of the pharmacist and a warning label, the over-the-counter medications lack all this. Patients also often assume that over-the-counter necessarily means safe.”
The FDA’s warning comes 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.
For prescription NSAIDs, the new FDA warning recommends limiting 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 are 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.
Makers of OTC NSAIDs intended for adults will also make similar updates to their labeling, according to the agency.