Arcoxia Use In Pregnancy & Lactation

PREGNANCY: The use of ARCOXIA, 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 ARCOXIA. Studies in animals have shown reproductive toxicity. The potential for human risk in pregnancy is unknown. ARCOXIA, as with other medicinal products inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester. ARCOXIA is contraindicated in pregnancy. If a woman becomes pregnant during treatment, ARCOXIA must be discontinued.
Cases of fetal renal dysfunction that have resulted in reduction of amniotic fluid volume (oligohydramnios) have been reported in pregnant women treated with non-steroidal anti-inflammatory drugs (NSAIDs) at 20 weeks of gestation or later. In some cases, this may result in neonatal renal dysfunction. Such effects may occur shortly after NSAID treatment initiation; oligohydramnios is often reversible after treatment discontinuation. Use of ARCOXIA is not recommended in pregnancy from 20 weeks of gestation onwards.
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.
NURSING MOTHERS: 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.