Arthoxib-120 Use In Pregnancy & Lactation

Pregnancy: The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive.
No clinical data on exposed pregnancies are available for etoricoxib. Studies in animals have shown reproductive toxicity. The potential for human risk in pregnancy is unknown. Etoricoxib, as with other medicinal products inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester. Etoricoxib is contraindicated in pregnancy. If a woman becomes pregnant during treatment, Etoricoxib must be discontinued.
Reproductive studies conducted in rats have demonstrated no evidence of developmental abnormalities at doses up to 15 mg/kg/day (approximately 1.5 times the human dose (90 mg) based on systemic exposure). At doses approximately 2 times the adult human exposure (90 mg) based on systemic exposure, a low incidence of cardiovascular malformations and increases in post-implantation loss were observed in etoricoxib-treated rabbits. No developmental effects were seen at systemic exposure of approximately equal to or less than the daily human dosage (90 mg). However, there was a decrease in embryo/foetal survival at exposures greater than or equal to 1.5 times the human exposure. Animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women.
Lactation: It is not known whether etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use etoricoxib must not breast feed.