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Etodolac Pregnancy and Breastfeeding Warnings

Etodolac is also known as: Lodine, Lodine XL

Etodolac Pregnancy Warnings

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. Administration of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy may cause significant adverse effects, including premature closure of the fetal ductus. There are no controlled data in human pregnancy. Administration during labor and delivery is not recommended; onset of labor may be delayed and duration increased with greater bleeding tendency in mother and child. NSAIDs may impair female fertility; withdrawal of NSAID therapy should be considered in women with difficulties conceiving or who are undergoing investigation of infertility. 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.

Use should be avoided during the third trimester of pregnancy. Prior to third trimester: Use only if potential benefit justifies the potential risk to the fetus. US FDA pregnancy category: C Comments: -Avoid use during third trimester as it may cause premature closure of the ductus arteriosus. -Not recommended in women attempting to conceive as may impair female fertility.

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

References for pregnancy information

  1. "Product Information. Lodine (etodolac)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Etodolac ER (etodolac)." Taro Pharmaceuticals U.S.A. Inc, Hawthorne, NY.

References for breastfeeding information

  1. "Product Information. Etodolac ER (etodolac)." Taro Pharmaceuticals U.S.A. Inc, Hawthorne, NY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Lodine (etodolac)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

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