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New FDA Warning About Using Common Pain Relievers During Pregnancy

The US Food and Drug Administration (FDA) just issued a new warning about taking non-prescription and prescription pain relievers known as nonsteroidal anti-inflammatory agents (NSAIDS) during pregnancy. The FDA warned that using them from week 20 or later during pregnancy can cause rare, but serious, kidney complications in the unborn baby. This can lead to low levels of amniotic fluid (called oligohydramnios) surrounding the baby and possible complications.

The FDA advice is to avoid the following NSAIDs from week 20 and later of pregnancy: ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, and celecoxib (Celebrex). However, low dose (81 mg) aspirin is excluded from this warning. [See FDA warning for more information.]

The FDA had earlier warned about those same NSAIDs - cautioning to avoid taking them during pregnancy after week 30 because of heart-related risks.

The full warning and information from US FDA: FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid

Excerpts from Medscape: FDA Issues New NSAIDs Warning for Second Half of Pregnancy

The US Food and Drug Administration released new warnings today that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in an unborn children when taken around weeks 20 or later in pregnancy. 

Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.

Manufacturers of both over-the-counter and prescription NSAIDs — including ibuprofennaproxendiclofenac, and celecoxib — will be required to update their labeling with the new warning.

Low-dose (81 mg) aspirin is excluded from this warning.

Oligohydramnios can arise quickly — in as little as 2 days — or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.

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