FDA expands pregnancy complications warning on common pain relievers
Women who are 20 weeks pregnant must exercise caution before taking pain relievers as it could lead to kidney-related complications for the unborn.
The Food and Drug Administration (FDA) has expanded its warnings on common pain relievers concerning pregnancy complications. The agency required labeling changes for a number of nonsteroidal anti-inflammatory drugs (NSAIDs).
In a press release, the FDA announced labeling changes that would include an explanation that if pregnant women would take these medications at 20 weeks of their pregnancy or later, it could possibly lead to health problems for the unborn baby. One possible complication is a rare but serious kidney problem, which can lead to low amniotic fluid levels. The amniotic fluid is the protective cushion that protects the baby in the tummy. Warnings for other potential pregnancy-related complications must be included as well.
NSAIDs that were included in the FDA warning were ibuprofen, diclofenac, naproxen, and celecoxib. For a long time, people have relied on these medicines to reduce pain by blocking the production of chemicals that cause inflammation. These medicines are both over-the-counter and prescription. The release emphasised though that the recommendation does not apply to the usage of low-dose aspirin at 81 mg. For some women, low-dose aspirin could be an important treatment for as long as it could be taken upon doctor's advice.
In the Drug Safety Communication, it was noted that the warning came following a review made by the FDA of cases that were reported to the agency concerning low amniotic fluid, as well as kidney problems in babies who are still in the womb.
The agency revealed that after approximately 20 weeks, the unborn baby's kidneys start producing most amniotic fluid. Fetal kidney problems could hamper the levels of amniotic fluid at this stage. Oligohydramnios, is a condition wherein there is a low level of amniotic fluid and is often detected after days or weeks of taking NSAIDs. It is also possible for the condition to be detected two days after use. When the pregnant woman stops taking this medication, the condition would also go away.
FDA required prescription NSAIDs to describe the risk of kidney problems in the unborn, which could result in low amniotic fluid. It also must warn of limited usage only between 20 to 30 weeks of pregnancy due to the attached risk. Prior to the expansion, there are already warnings on taking NSAIDs at more than 30 weeks of pregnancy as it could lead to heart-related problems in the unborn.
Dr Patrizia Cavazzoni, FDA's Center for Drug Evaluation and Research acting director said that it is important for women to understand the risks and benefits of the medications that they are taking while pregnant. The agency is using its authority to better inform women and health care providers of the risks of using NSAIDs during 20 weeks of pregnancy and beyond.
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