Health
FDA warns against pregnant NSAIDs after 20 weeks
FDA Drug safety communication For the use of non-steroidal anti-inflammatory drugs (NSAIDs) during pregnancy, the product label requires that the product label include a warning about the risk of rare but serious kidney complications in infants.
The use of over-the-counter or prescription analgesics such as aspirin, ibuprofen, naproxen, diclofenac, and celecoxib after 20 weeks of gestation can cause fetal nephropathy, reduced amniotic fluid levels, and pregnancy complications. Said.
Current prescription drug labeling does not currently recommend the use of NSAIDs after 30 weeks of gestation due to the high risk of fetal heart problems, but the FDA recommends for drugs from 20 weeks. Said to expand labeling.
Authorities have identified 35 reports of babies with low amniotic fluid or kidney problems after their mothers took NSAIDs during pregnancy. This included two babies with both renal failure and decreased amniotic fluid levels, and three babies who died with renal failure but low amniotic fluid levels.
Eleven babies with low amniotic fluid had improved water levels after their mother stopped taking NSAIDs. In most cases, the detrimental condition of the fetus returned to normal 3 to 6 days after the mother stopped using the drug.
The fetus begins to produce most amniotic fluid about 20 weeks after pregnancy. Oligohydramnios (low fetal amniotic fluid levels) may be detected after taking NSAIDs for days or weeks, but can be noticed after just two days of use.
“It’s important to understand the benefits and risks of drugs that women may take during pregnancy,” said Patrizia Cavazzoni, MD, Deputy Director of the FDA’s Center for Drug Evaluation and Research. statement.. “For this purpose, authorities are using regulators to inform women and their healthcare providers about the risks of using NSAIDs after the 20th week of pregnancy.”
For prescription drugs, the FDA is requesting changes to prescribing information that recommends prescribing to pregnant people during the 20th to 30th week of pregnancy. Manufacturers of off-the-shelf NSAIDs should make similar label changes for adults.
Aspirin is an NSAID, but low-dose aspirin (81 mg) is an exception to these recommendations as it is an important treatment for pregnant women. The FDA recommended prescribing the lowest effective dose in the shortest possible time if the healthcare provider believes that the use of NSAIDs is absolutely necessary after 20 weeks of gestation.
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