In its Drug Safety Communication, dated 10/15/2020, the Food and Drug Administration (FDA) announced that manufacturers of nonsteroidal anti-inflammatory drugs (NSAIDs) will be required to update their labeling to include warnings about potential fetal risk if women take the medications at about 20 weeks or later in their pregnancy.
This is of special concern to dentistry since the use of NSAIDs like ibuprofen and naproxen in the management of acute dental pain is well documented. Non-opioid analgesics, like NSAIDs and acetaminophen, are considered the mainstay of dental pain management, as an alternative to, and especially to reduce the frequency of use of, opioid analgesics, during this period of opioid overuse, misuse, dependence and addiction, both in the United States and throughout the world.
The FDA explained the warning follows a review of the medical literature and cases reported to the agency involving rare but serious kidney problems in unborn babies associated with NSAID use during pregnancy. After about 20 weeks of pregnancy, the unborn baby’s kidneys start producing most of the amniotic fluid, so fetal kidney problems can cause low levels of this fluid, a condition known as oligohydramnios. Oligohydramnios may be detected after taking the medicine for days or weeks, but it may be detected as soon as two days after initiation of regular NSAID use.
A search of the FDA Adverse Event Reporting System found that oligohydramnios associated with NSAID use during pregnancy was identified in 35 cases. Neonatal death was reported in 5 of these cases. However, in 11 of these cases, amniotic fluid volume returned to normal after the NSAID was discontinued.
For prescription NSAIDs, the prescribing information must be updated to describe the risk of kidney problems in unborn babies that result in low amniotic fluid and to recommend avoiding the use of NSAIDs in pregnant women at 20 weeks or later. The prescribing information already includes warnings to avoid taking NSAIDs after about 30 weeks of pregnancy, as taking these medications during this time could lead to heart issues in the unborn baby. The manufacturers of OTC NSAIDs intended for adult use must also make the required updates to their labeling. Interestingly, the recommendation does not apply to low-dose aspirin (81mg), which has been prescribed for certain conditions in pregnancy.
The FDA stated that if treatment with NSAIDs during pregnancy is deemed medically necessary, it recommends that the use of NSAIDs should be limited to the lowest effective dose and shortest duration possible. The FDA added that although certain health care providers treating pregnant women generally know about the risk of low levels of amniotic fluid, the Agency is communicating this information more broadly to educate other health care professionals and pregnant women, especially since NSAIDs are available by prescription as well as over-the-counter.
FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications, Drug Safety Communication, US Food and Drug Administration; October 15, 2020. https://www.fda.gov/news-events/press-announcements/fda-warns-using-type-pain-and-fever-medication-second-half-pregnancy-could-lead-complications. Accessed 10/18/20.
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