The Federal Food and Drug Administration (FDA) is concerned that nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin, ibuprofen, and naproxen may pose a danger to women who are 20 weeks or more into their pregnancy. The concern is that the NSAIDs may cause their unborn child to develop kidney problems which can result in low amounts of amniotic fluids.
According to the FDA, the kidneys of an unborn baby produce most of the amniotic fluid the baby needs. Amniotic fluid helps with the development of the lungs, muscles, and the digestive system of the baby. Analysis of the relationship between NSAIDs and pregnancy showed that “among the 35 cases of low amniotic fluid levels or kidney problems reported to FDA through 2017, all were serious.” Some newborns died. In 11 cases, stopping the NSAID helped the amniotic fluid level return to a normal level.
The FDA says that its warning applies to over the counter and prescription medications.
The FDA warning
The FDA is now:
- Requiring that the prescribing information should:
- Indicate that unborn babies may develop kidney problems and a low amniotic fluid level
- Indicate the health care professionals “should consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours”
- Recommending that pregnant women stop using NSAIDs 20 weeks or more into their pregnancy
- Informing health care physicians who recommend NSAIDs after 20 weeks, that if necessary, they should use the lowest dose level for the shortest time period
The FDA is also updating its “Drug Facts labels of OTC NSAIDs intended for use in adults.” Current labels already include other birth injury warnings – such as that NSAIDs can cause complications if used during the last three months of the pregnancy and that mothers should speak to their physicians before using an NSAID.
There is one exception, according to the FDA: using 81mg doses of NSAID aspirin for some pregnancy conditions – with the advisement of the woman’s doctor – may be acceptable.
What are NSAIDs, anyway?
NSAIDs are often used to treat pain, fever, cold, the flu, menstrual cramps, insomnia, and arthritis. The more popular brands include:
Note that the FDA has not issued a warning against any of these specific brands as opposed to other brands; the warning is for all NSAID drugs.
Pregnant women should be aware that many OTC medications do contain NSAIDs, and that should be listed on the box or bottle. Your pharmacist or doctor can tell you if your prescription medication contains an NSAID. Ask your doctor about alternative medications that can treat your symptoms. If you took a medication that did not list NSAID on its ingredient list, and your child suffered an injury or developer a birth defect as a result, you may be able to file a product liability claim against the drug manufacturer.
At Bailey & Greer, PLLC, our Memphis birth injury lawyers understand how devastating it is when a newborn dies or is born with serious health problems. Our lawyers are respected for our strong advocacy and our track record of success in handling birth injury cases. We’ve been fighting for newborns and parents for nearly 32 years. We demand compensation for the extensive medical bills and the physical, emotional, and developmental injuries medical malpractice causes. Please call 901-475-7434 or fill out our contact form to schedule a free consultation at our Memphis or Jackson office.
As founder of Bailey & Greer, R. Sadler Bailey has battled his fair share of insurance giants and wrongdoers and has achieved numerous multimillion-dollar results for the victims of catastrophic injuries and their families. What’s more, he has been involved in more than 40 appellate court decisions affecting Tennessee personal injury law, including many landmark appearances before the Tennessee Supreme Court.
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