February 2, 2021

FDA Warns NSAID Use in Second Half of Pregnancy Could Cause Complications

The Food and Drug Administration (FDA) recently issued a Drug Safety Communication changing the labeling of NSAIDS, a class of painkillers, to warn that NSAIDS can cause a rare but serious kidney problem in unborn babies. According to the FDA, “These changes include new labeling to explain that if women take the medications around 20 weeks or later in their pregnancy, the drugs 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 the potential for pregnancy-related complications.”

What Is an NSAID?

NSAID stands for NonSteroidal Anti-Inflammatory Drugs. NSAIDs are prescribed to treat pain and fever for many conditions. Some commmonly used NSAIDs are aspirin, ibuprophen (Motrin, Advil), naproxin (Aleve, Naprosyn) and celecoxib (Celexa). The FDA is now requiring a change to the warning label about the risk of kidney problems in unborn babies between 20-30 weeks of pregnancy.

Oligohydramnios and Fetal Injury

An unborn baby is enveloped in amniotic fluid, mostly water, from their mother from the beginning. But at 20 weeks the unborn baby’s kidneys begin to take over producing amniotic fluid. NSAIDs can cause a rare but serious kidney problem in the unborn baby, called oligohydramnios. Very simply, oligohydramnios is low levels of amniotic fluid in the baby.

Oligohydramnios can develop within days of taking an NSAID, but may be detected as far out as two weeks later. Once the mother stops taking NSAIDS, the conditition usually goes away.

FDA Warns About Serious Kidney Problems In Unborn Babies

The new warning label, approved by the FDA on October 15, 2020, recommends that pregnant women not use NSAIDs at 20 weeks or later in their pregnancies. It recommends that medical professionals also do not prescribe NSAIDs at this time in the pregnancy. If NSAID treatment is absolutely necessary, the FDA recommends prescribing the lowest possible effective dose for the shortest duration possible. If NSAIDs are prescribed for more than 48 hours at 20 weeks or later, monitoring of amniotic fluid should be considered.

NSAIDs already had a warning label against taking them after 30 weeks gestation, because of the risk of possible heart problems in the baby.

What Medical Conditions Can Low Amniotic Fluid Cause?

The FDA warns that low amniotic fluid (oligohydramnios) caused by taking NSAIDs during week 20 and after of pregnancy may cause the baby to suffer renal (kidney) damage or failure, and possibly death. Taking those drugs can also cause other serious pregnancy complications, including the development of the baby’s lungs, the muscles, and the digestive system.

What Can You Do?

If you took NSAID during weeks 20 and later of your pregnancy, and your baby suffered from or was lost to kidney, lung, muscle or digestive system damage, you may have a claim for damages. Contact the attorneys at Thornton Law Firm for a free, thorough evaluation of your legal rights at 1-888-491-9726. Or tell us your story using our online contact form. Like all lawsuits, birth defect claims related to NSAID use must be filed within short time limits. Seek legal advice as soon as possible to protect you and your baby’s rights.

Contact Us