FDA Issues Warning about Nonsteroidal Anti-inflammatory Drugs for Pregnant Women
The Federal Food and Drug Administration (FDA) recently posted an updated warning on its website about the risk of taking nonsteroidal anti-inflammatory drugs (NSAIDs) during pregnancy. In order to reach the wider medical community, they publicly announced that pregnant women taking NSAIDs during the third trimester, or at any point from week 20 and later, may cause kidney damage in the fetus and reduced levels of amniotic fluid. This class of drugs has been deemed a risk for pregnancy in its later stages, having been associated with a serious condition known as oligohydramnios and other birth complications.
What are NSAIDs?
Some people swear by them; others claim they do more harm than good. NSAIDs, or nonsteroidal anti-inflammatory drugs, are pain and fever relievers commonly sold over the counter in lower doses than prescription versions. Over the counter, they go by such common names as Advil, Aleve, Bayer, Excedrin, Motrin, and Midol, to name a few. Examples of NSAIDs include aspirin, ibuprofen, diclofenac, celecoxib, and naproxen, that relieve cold and flu symptoms, such as cough, headaches, and fever, as well as provide relief for arthritis pain or insomnia. While over the counter NSAIDs like Advil and Motrin are used for everyday colds, flus, aches and pains, Midol is marketed as pain reliever for menstrual cramps, capitalizing on these drugs’ capacity to reduce inflammation. However, stronger Ibuprofen, the primary ingredient in these brand names, may be prescribed for arthritis, headaches, or severe pain from injuries.
Although NSAID products are so popular that they line the shelves of most pharmacy aisles in supermarkets and drug stores, some people may experience side effects from NSAIDs, such as gas, diarrhea, constipation, stomach pain, heartburn, nausea, dizziness, and vomiting. For those who do not, these drugs can provide much needed relief for momentary, as well as chronic conditions that cause pain or discomfort.
What is the Connection between NSAID Drugs and Infant Complications?
While the kidney problem referred to as oligohydramnios is rare, it does occur, often resulting in serious complications. Fluid in the amniotic sac is necessary for the growing fetus’s protection, along with growth of the lungs and digestive system. The fluid is made by the fetus’s lungs and kidneys. Past five months, the developing baby’s kidneys increase amniotic fluid production, so reduced kidney function results in less amniotic fluid, which could lead to severe health issues. The FDA cites studies confirming the correlation between NSAIDs and low amniotic fluid, serious kidney failure, and fetal death. Specifically, all subjects of one study had low amniotic fluid that recovered after NSAIDs were stopped. However, not all oligohydramnios is reversible. The dangers of low amniotic fluid to the fetus in the third trimester are varied but may include slowed fetal lung development, possibly causing other complications. The potential results of low amniotic fluid include:
- Birth defects
- Kidney failure
- Lifelong respiratory disabilities
- Umbilical cord problems
- Intrauterine growth restriction (IUGR)
- Labor and delivery complications
- Premature birth
- Increased likelihood of cesarean section birth
- Miscarriage and infant death
In addition to frequent monitoring and fluid measurement, a severe case of oligohydramnios may require amnioinfusion, by which saline solution is injected into the uterus via the cervix in order to increase the quantity of amniotic fluid.
What is being done about NSAIDs during Pregnancy?
As a result of this newly announced warning, the FDA has implemented changes in the warning labels of NSAIDs to include the kidney danger to developing fetuses if used at twenty weeks or later. Labels already include the warning label language about NSAID use at 30 weeks or later, which may lead to heart problems in unborn babies. The FDA now also recommends that doctors avoid prescribing NSAIDs to pregnant women in their third trimester, but if they must prescribe them for longer than 48 hours, to monitor their patients’ amniotic fluid by ultrasound. Over the counter NSAIDs bear the warning that use during pregnancy in the last trimester can lead to birth complications. They further advise pregnant and breastfeeding women to consult with their doctors before using them. To be safe, acetaminophen is an alternative to unmonitored and uncontrolled use of NSAIDs. Also, since many pain relievers and other medications contain NSAID compounds, it is important to read labels for anything taken while pregnant. It is likewise imperative for doctors to inform patients of which drugs are safe, to monitor women taking any medications while pregnant, and to rapidly identify warning signs that something is amiss for the mother or her child.
What if my Doctor Failed to Warn me about Taking NSAIDs during Pregnancy?
Pregnancy represents one of the many conditions that comes with minor and major discomfort, from cramping and swelling to headaches and nausea. Nonetheless, it has long been held that NSAIDs are not good for the developing fetus in pregnant women during the last trimester. Doctors should be aware of this. If your physician prescribed NSAIDs in your last trimester, you might want to investigate whether they negligently caused your baby’s kidney damage and resulting treatment. Even if your doctor did not know of the specific risk of kidney failure, they should know that these drugs risk harm to the unborn child. With so many ways to avoid using nonsteroidal anti-inflammatory drugs or using them unsafely, you wonder how you could have avoided your baby’s harm. Had your doctor diligently monitored your use of NSAIDs in your third trimester, treated oligohydramnios, or refrained from prescribing a dangerous drug in the first place, you may rightfully wonder if despite their negligence, your baby might not have been injured.
You trust in your medical care and never suspect that an avoidable error could lead to devastating consequences, and then it does. If your child experienced oligohydramnios, kidney complications, or other birth injuries, find out what you may be able to do to ensure that your baby’s future medical and therapeutic costs are covered. Contact a knowledgeable New Jersey pregnancy malpractice attorney who can examine your case, evaluate your possible claim for compensation, advise you about what to do next, and vigorously represent your family’s interests. Call (866)-708-8617 for a free consultation today.
- FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications
- FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid
- Oligohydramnios, Merck Manual, Gynecology and Obstetrics
- Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Cleveland Clinic