Federal drug regulators are warning women to avoid common, over-the-counter painkillers, such as Aleve and Motrin, during the second half of their pregnancy, due to the risk of kidney injuries to the unborn child and other complications.
The FDA issued a drug safety communication on October 15, indicating nonsteroidal anti-inflammatory drugs (NSAIDs) should not be used after 20 weeks or later into a pregnancy.
The warning indicates these drugs, including Motrin (ibuprofen), Aleve (naproxen) as well as Celebrex (celecoxib) and diclofenac, block the production of certain chemicals in the body, which can result in rare, serious kidney problems in the unborn child.
The agency indicates these kidney problems can cause low levels of amniotic fluid and pregnancy-related complications. It is requiring changes to the prescribing information of all NSAIDs, which will include a recommendation that use of NSAIDs be limited during the 20th and 30th weeks of pregnancy and should be avoided entirely after that, due to additional risks to the unborn baby’s heart.
If NSAIDs are required during those periods of pregnancy they should be limited to the lowest effective dose and shortest duration possible, according to the FDA’s warning.
In addition, over-the-counter NSAIDs, like Motrin and Aleve, will carry similar warnings on their Drug Facts labels.
“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 the FDA’s Center for Drug Evaluation and Research, said in a press 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.”
The agency issued the warning following a review of media literature and cases which were reported directly to the agency. The reports found that NSAIDs led to fetal kidney problems which led to low amniotic fluid levels, known as oligohydramnios. The condition can occur as little as two days after starting regular NSAID use, but usually goes away if the pregnant woman stops taking the drugs, according to the warning.
The FDA noted that some health care providers are already aware of the problem, and made the move to more broadly warn the medical community and pregnant women of the potential risks.
The agency noted the warning does not apply to low doses of aspirin of 81 mg or less.
The FDA is calling on health care professionals and patients to report any side effects from NSAIDs to the FDA MedWatch adverse event reporting program.