Taking NSAIDs during this time of pregnancy can cause kidney problems in unborn babies

Taking NSAIDs around 20 weeks or later in the pregnancy can cause rare but serious kidney problems in the unborn baby, which can lead to low levels of amniotic fluid, warns FDA.

The U.S. Food and Drug Administration (FDA) recently recommended changes in the labeling for nonsteroidal anti-inflammatory drugs (NSAIDs). In particular, it requires that the labeling of NSAIDs include a warning regarding the use of these medications during pregnancy.

The US drug regulator warned that taking these drugs around 20 weeks or later in the pregnancy can cause rare but serious kidney problems in the unborn baby, which can lead to low levels of amniotic fluid (the protective cushion surrounding the unborn baby) and increase the risk for pregnancy-related complications.

NSAIDs such as ibuprofen, naproxen, diclofenac, and celecoxib are widely used to relieve pain, reduce inflammation, and treat fever. There are both prescription and over-the-counter (OTC) NSAIDs.

However, these recommendations do not apply to the use of low-dose aspirin (81 mg), which is also an NSAID. Pregnant ladies, take note - Aspirin should be taken under the direction of a health care professional.

"It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy. To this end, the agency is using its regulatory authority to inform women and their health care providers about the risks of NSAIDs are used after around 20 weeks of pregnancy and beyond," said Patrizia Cavazzoni, M.D., acting director of FDA's Center for Drug Evaluation and Research, in a press release.

The FDA recommended labeling changes for NSAIDs after reviewing medical literature and cases reported to the agency about kidney problems in unborn babies associated with the use of pain and fever drugs during pregnancy.

Sife effects of taking NSAID during pregnancy

After about 20 weeks of pregnancy, the fetus's kidneys begin producing most of the amniotic fluid. Thus, kidney problems in unborn babies can cause low levels of amniotic fluid, a condition known as oligohydramnios.

According to the FDA warning, this condition may be detected as soon as two days after initiation of regular NSAID use and usually goes away if the pregnant woman stops taking the medicine.

For prescription NSAIDs, the FDA made changes to the prescribing information recommending that NSAID use between about 20 weeks to 30 weeks of pregnancy be limited because of this risk. The prescribing information already has warnings to avoid taking these drugs after about 30 weeks of pregnancy explaining that they may lead to heart issues in the unborn baby.

"If a health care provider believes NSAID use is necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible," the drug regulator noted in its release.

It asked manufacturers of OTC NSAIDs intended for adult use to make similar updates to the Drug Facts labels.

Warnings associated with NSAID use

The FDA made it compulsory that the labeling of NSAIDs contain these warnings:

• NSAIDs may increase the risk of serious stomach and bowel side effects like ulcers and bleeding. It may occur more commonly in older people and those who have a previous history of stomach ulcers or bleeding problems. The risk is also higher in people who are on blood thinners or multiple prescription/over-the-counter NSAIDs or drinking three or more alcoholic beverages per day.

The warnings for non-aspirin NSAIDs include:

• Non-aspirin NSAIDs can increase the chance of heart attack or stroke, especially in those who have heart disease or risk factors (for example, smoking, high blood pressure, high cholesterol, diabetes) for heart disease.
• Heart problems caused by non-aspirin NSAIDs can happen within the first weeks of use and may increase with higher doses or with long-term use.
• Avoid non-aspirin NSAIDs use right before or after heart bypass surgery.