Date:
November 2, 2020
Issue #:
1610
Summary:
The FDA has required a new warning in the labels of
prescription and over-the-counter products containing
nonsteroidal anti-inflammatory drugs (NSAIDs) advising
against their use during pregnancy beginning at 20
weeks’ gestation because of a risk of renal dysfunction
in the fetus that could lead to low amniotic fluid levels
(oligohydramnios) and neonatal renal impairment.
NSAID labels previously warned against use of the drugs
beginning at 30 weeks’ gestation because of a risk for
premature closure of the ductus arteriosus and persistent
neonatal pulmonary hypertension
prescription and over-the-counter products containing
nonsteroidal anti-inflammatory drugs (NSAIDs) advising
against their use during pregnancy beginning at 20
weeks’ gestation because of a risk of renal dysfunction
in the fetus that could lead to low amniotic fluid levels
(oligohydramnios) and neonatal renal impairment.
NSAID labels previously warned against use of the drugs
beginning at 30 weeks’ gestation because of a risk for
premature closure of the ductus arteriosus and persistent
neonatal pulmonary hypertension
