On October 15, 2020, the U.S. Food and Drug Administration (FDA) announced mandatory labeling changes for nonsteroidal anti-inflammatory drugs (NSAID). The modified labels for these medications will warn women that if they take the drugs at 20 weeks or later in their pregnancy, their unborn babies could suffer serious kidney problems. These conditions can prompt low levels of amniotic fluid, a substance that the fetus relies on for protection. Ultimately, complications with the pregnancy might result.
How NSAIDs Can Hurt Unborn Babies
While in utero, babies depend on amniotic fluid for its protective cushioning. The fluid also facilitates the development of the baby’s lungs, muscles, and digestive system.
As the FDA’s warning explains, a fetus’s kidneys start to produce most of the amniotic fluid that surrounds them at or around 20 weeks into a pregnancy. It stands to reason, then, that if the unborn child suffers from kidney problems, this could lead to low levels of amniotic fluid.
This condition, known by the medical term oligohydramnios, manifests after weeks or even just days of a pregnant woman’s regular NSAID use—with some cases becoming detected in as few as two days after such use. The FDA also notes that typically, when the expecting mother ceases taking the NSAID, the low-amniotic-fluid-level condition correspondingly reverses.
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The Research That Prompted FDA’s Warning
Any time an individual or physician notes a negative outcome, side effect, or complication from using a medication or medical device, they can report the incident to the FDA’s MedWatch program. The FDA monitors this database and watches for trends that might require further investigation. This is what happened in the case of NSAIDs.
The FDA received incident reports about kidney problems and low amniotic fluid levels in unborn babies whose mothers had used NSAIDs while pregnant.
Specifically, the FDA found that through 2017, 35 cases of low amniotic fluid levels or kidney problems were reported prior to issuing this warning. Each of these cases indicated serious problems. Keep in mind that not every patient or doctor who experienced such medical issues reported them to the FDA, so these numbers likely underrepresent the risks.
Medical Problems Noted in FDA’s MedWatch
Reports to the FDA Adverse Event Reporting System (FAERS) database involving NSAID-related medical problems in unborn babies included the deaths of five newborns due to kidney failure. In two cases, physicians reported low amniotic fluids. In three cases, healthcare providers did not confirm low amniotic fluids.
In the cases of confirmed low levels of amniotic fluid, the condition started as soon as 20 weeks into the pregnancy. In 11 other incidents, doctors reported low amniotic fluids in which fluid levels resumed healthy levels after the patient stopped taking NSAIDs.
These reports echoed what FDA researchers noted in the medical literature on this topic. This literature showed that when pregnant women took NSAIDs, they experienced low amniotic fluids for a time span of 48 hours to several weeks. If the patient discontinued the use of the NSAID, fluid levels returned to normal within three to six days. If the patient then resumed taking NSAIDs, the condition of low fluid levels returned.
What the Warning Means for Pregnant Women Taking Prescription NSAIDs
With its mandated changes, new prescription information must convey the risk of kidney problems and low amniotic fluid that unborn babies face when a pregnant woman takes NSAID medications. The information should specifically recommend that the patient limit consumption of NSAIDs upon entering the 20- to 30-week phase of her pregnancy.
Check Drug Facts Labels
The FDA urges pregnant women to talk to their doctors about how to weigh the benefits and risks of taking NSAIDs during pregnancy. Furthermore, because so many over-the-counter drugs contain NSAIDs, the FDA stresses that pregnant women need to carefully read all Drug Facts labels in their medicine cabinets to check whether NSAIDs appear as an ingredient.
Drug facts labels for NSAIDs already warn pregnant women about the risks of taking such drugs during the final three months of pregnancy because of medical problems they might create for the child, as well as delivery complications the drugs can cause.
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Know Your NSAID Medications
The FDA’s warning touches the vast number of people who purchase NSAIDs every day as over-the-counter pain relievers. This group of drugs blocks the production of inflammation-causing chemicals in the human body.
People take these medications to relieve pain and fever, as well as to minimize inflammation from muscle strains or sprains, or arthritis. Other common ailments that the drugs treat include headaches, menstrual cramps, insomnia, pain, coughs, flu, and colds.
Recognizing NSAIDs in Your Medicine Cabinet
Popular forms of NSAIDS include the following:
- Aspirin
- Ibuprofen, such as Advil and Motrin
- Naproxen, such as Aleve and Naprosyn
According to the FDA, low-dose aspirins (81mg) do not present the same risks during pregnancy as other NSAIDs. Rather, the agency appreciates aspirin as an important treatment for many pregnant women and recommends that they continue to take it as needed under the supervision of their physicians.
Some patients receive prescriptions for other formulations of NSAIDs:
- Celecoxib (brand name Celebrex)
- Nabumetone (brand name Relafen)
- Diclofenac
With the exception of administering these medications to children and to those who suffer from heart disease, kidney disease, high blood pressure, or digestive tract bleeding, NSAIDs have long been considered safe for most people who take them.
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How This Warning Affects Healthcare Providers
Many specialty healthcare providers already know about risks to an unborn baby when a pregnant woman takes NSAIDs. The agency hopes to cast a wider net and inform all medical providers of these risks.
Minimize Dosages and Durations and Monitor
If a pregnant woman’s condition prompts her physician to believe that NSAIDs are necessary during this risky timeframe, they should ensure that the patient takes only the lowest effective dose. They should also limit usage to the shortest duration possible to achieve the desired outcome without increasing risks to the unborn baby.
If the treatment of a pregnant patient involves administering NSAIDs for a period greater than 48 hours, the FDA further suggests that the treating physician implement ultrasound monitoring of the baby’s amniotic fluid. If such monitoring indicates oligohydramnios, the medical provider should stop the NSAID treatment.
Reporting NSAID Problems
The FDA urges both patients and their healthcare providers to use the MedWatch online voluntary reporting form to alert the agency of any negative incidents, side effects, or complications they experience when using NSAIDs.
Patients who experienced these issues can also reach out to the Birth Injury Lawyers Group to review the case. There may be grounds for compensation. Reach out to our firm at (800) 222-9529 today.
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