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Rofecoxib Pregnancy and Breastfeeding Warnings

Rofecoxib is also known as: Vioxx

Rofecoxib Pregnancy Warnings

Merck pharmaceuticals encourages healthcare providers to report any prenatal exposure to rofecoxib by calling the Pregnancy Registry at (800)-986-8999. The registry has been created to monitor the pregnancy outcomes of women exposed to rofecoxib while pregnant.

Rofecoxib has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity. Data from human pregnancy studies are not available. Rofecoxib should only be given during pregnancy when benefit outweighs risk. The manufacturer recommends that rofecoxib be avoided in late pregnancy (third trimester) due to the risk of premature closure of the ductus arteriosus.

Rofecoxib Breastfeeding Warnings

There is no data on the excretion of rofecoxib into human milk. 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.

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