Can the use of indomethacin be used during pregnancies?
NSAIDs should not be used during the last 20 weeks of a pregnant woman's life because of the risk of premature birth.If NSAID use is necessary between 20- and 30-weeks' gestation, limit use to the lowest effective dose for the shortest duration possible.
Pre- and post-implantation loss has been shown in animal studies to be caused by prostaglandin synthesis.Data from observational studies is not conclusive regarding embryofetal risks.Epidemiological studies show an increased risk of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor.The absolute risk for cardiovascular malformation increased from less than 1% to 1.5 %, and this risk is believed to increase with dose and duration of therapy.NSAID use during the third trimester of pregnancy increases the risk of premature fetal ductus arteriosus.There are no controlled data in human pregnancies. The FDA is requiring a new warning be added to NSAID labeling to describe the risk of fetal kidney problems that may result in lowamniotic fluid.The FDA does not recommend NSAID use for pregnant women.The FDA has received 35 reports of lowamniotic fluid levels in mothers who took NSAIDs while pregnant.Five newborns died, two had confirmed lowamniotic fluid and three had no confirmation at all.The lowamniotic fluid began as early as 20 weeks of pregnancy.After the NSAID was stopped there were 11 reports of lowamniotic fluid levels.The medical literature has reported lowamniotic fluid levels with use of NSAID for varying amounts of time.Leg contractures and delayed lung maturation can be caused by long-term oligohydramnios.In some cases, transplant procedures were required.In some cases, the condition could be reversed within 3 to 6 days of stopping the NSAID.The withdrawal of NSAID therapy should be considered in women with difficulties in conception or who are undergoing investigation of infertility.The effects may be reversed in the future.The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescriptions.The categories A, B, C, D, and X are being phased out.
According to some manufacturers, use is not recommended due to low levels of breastmilk and therapeutic administration directly to infants.The average concentration of breast milk in a small study where 11 out of 15 women received doses ranged from 75 to 300 calories per day was 0.21% of the maternal weight adjusted dose.One study reported a blood level of 47 mcg/L in 1 infant 1.2 hours after the end of breastfeeding in a mother who received a daily dose of 2.94 g/d.Maternal and infant levels of this drug were not measured.It was thought that this drug may have caused the seizures, however, later studies and established therapeutic use in newborns makes it unlikely.Other agents may be preferred due to lack of published clinical experience.
The benefit should outweigh the risk when it comes to human milk.The benefits of breastfeeding should be considered along with the mother's clinical need for this drug; other agents with more published information may be preferable, especially when nursing a newborn or preterm infant.
To ensure the information on this page applies to your personal circumstances, always consult your healthcare provider.