Etodolac Pregnancy and Breastfeeding Warnings

Brand names: Lodine, Lodine XL

Etodolac Pregnancy Warnings

NSAIDs should be avoided at 20 weeks gestation and later

US FDA pregnancy categories:
-Capsules and extended-release tablets: Not assigned.
-Immediate-release tablets: C

Risk Summary: Nonsteroidal anti-inflammatory drugs (NSAIDs) use in pregnant women at 30 weeks gestation and later may cause premature closure of the fetal ductus arteriosus; NSAID use at 20 weeks gestation or later may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Comments:
-NSAID use in pregnancy prior to 20 weeks gestation should be based on a benefit-risk assessment; some authorities recommend avoiding NSAIDs throughout pregnancy whenever possible.
-If NSAID use is necessary between 20- and 30-weeks' gestation, limit use to the lowest effective dose for the shortest duration possible; ultrasound monitoring of amniotic fluid should be considered if NSAID use extends beyond 48 hours; if oligohydramnios occurs, discontinue NSAID and treat appropriately.

Animal studies have revealed evidence of skeletal anomalies (i.e. polydactyly, oligodactyly, syndactyly, unossified phalanges, and synostosis of metatarsals), however, a direct drug or dose response relationship could not be established. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

US FDA pregnancy category Not Assigned: 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 prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Etodolac Breastfeeding Warnings

Use should be avoided.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

Since no information is available regarding use of this drug during breastfeeding, other agent may be preferred, especially while nursing a newborn or preterm infant.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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