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.

See references