Xobix - Teratogenic effects in Pregnancy
Xobix (Meloxicam) caused an increased incidence of septal defect of the heart, a rare event, at an oral dose of 60 mg/kg/day (64.5-fold the human dose at 15 mg/day for a 50 kg adult based on body surface area conversion) and embryo lethality at oral doses 5 mg/kg/day (5.4-fold the human dose, as noted above) when rabbits were treated throughout organogenesis.
Xobix (Meloxicam) was not teratogenic in rats up to an oral dose of 4 mg/kg/day (approximately 2.2-fold the human dose, as noted above) throughout organogenesis. An increased incidence of stillbirths was observed when rats were given oral doses 1 mg/kg/day throughout organogenesis. Xobix (Meloxicam) crosses the placental barrier. There are no adequate and well-controlled studies in pregnant women. Xobix (Meloxicam) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing mothers
Studies of Xobix (Meloxicam) excretion in human milk have not been conducted; however, Xobix (Meloxicam) was excreted in the milk of lactating rats at concentrations higher than those in plasma. Because of the potential for serious adverse reactions in nursing infants from Xobix (Meloxicam), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients under 18 years of age have not been established.
