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Celecoxib Pregnancy and Breastfeeding Warnings

Celecoxib is also known as: Celebrex

Celecoxib Pregnancy Warnings

Celecoxib has been assigned to pregnancy category C for the first 30 weeks of gestation and category D from week 30 forward by the FDA. Animal studies have revealed evidence of teratogenicity. Nonteratogenic effects in animal studies included pre-and post-implantation losses and reduced embryo/fetal survival. There are no controlled data in human pregnancy. Celecoxib is only recommended for use during pregnancy when benefit outweighs risk. The manufacturer recommends that celecoxib be avoided in late pregnancy (third trimester) due to the risk of premature closure of the ductus arteriosus.

Celecoxib Breastfeeding Warnings

Limited data show celecoxib is excreted into human milk in small amounts. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Celecoxib was measured in the milk of a 40-year-old woman after four doses of celecoxib 100 mg. She withheld breast-feeding her baby for 48 hours. Plasma concentrations from this woman predicted that nearly all of the drug would be eliminated from the breast milk within 24 to 36 hours (approximately 5 half-lives) after the mother had finished taking celecoxib. A report of two breastfed infants 17 and 22 months of age did not show any adverse events.

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