Impairment of Fertility: Atomoxetine hydrochloride did not impair fertility when administered to rats from 10 days of age through adulthood at oral doses up to 50 mg/kg/day (up to 7 times the maximum recommended daily oral dose in children and 4 times the maximum recommended daily oral dose in adults, on a mg/m2 basis). In addition, there was no evidence of impaired fertility in two studies in adult rats given atomoxetine in the diet at time-weighted average doses up to 57 mg/kg/day in males and 46 mg/kg/day in females (up to 6-8 times the maximum recommended daily oral dose in children and 4 times the maximum recommended daily oral dose in adults, on a mg/m2 basis).
Use in Pregnancy - Pregnancy Category B3: Pregnant rabbits were treated orally with up to 100 mg/kg/day atomoxetine throughout the period of organogenesis. At this dose, a decrease in live foetuses and/or an increase in early resorptions were observed, along with evidence of slight maternal toxicity. Slight increases in the incidences of major blood vessel variations were observed in 1 of 3 studies; the no-effect dose for the cardiovascular findings was 30 mg/kg/day. The 100 mg/kg/day dose is 14 times the maximum human dose on a mg/m2 basis; exposure (plasma AUC) to active moiety (atomoxetine + 4-hydroxyatomoxetine) at this dose is estimated to be less than that in EMs or PMs receiving the maximum human adult dose.
Rats were treated with up to 57 (males) and 46 (females) mg/kg/day of atomoxetine (4 times the maximum human adult dose on a mg/m2 basis) in the diet from 2 (females) or 10 (males) weeks prior to mating through the periods of organogenesis and lactation. In one study, decreases in fetal and pup body weight and fetal skeletal anomalies were seen at 41-98 mg/kg/day (3-7 times the maximum tolerated human adult dose on a mg/m2 basis) along with maternal toxicity and incisor overgrowth/teeth clipped was seen at 7 mg/kg/day or greater. In a second study, decreases in pup weight were seen at 46-70 mg/kg/day (4-5 times the maximum human adult dose on a mg/m2 basis) and reduced pup survival at 23-39 mg/kg/day (2-3 times the maximum adult dose on a mg/m2 basis) along with maternal toxicity. No adverse fetal effects were seen when pregnant rats were treated with up to 150 mg/kg/day (11 times the maximum human dose on a mg/m2 basis) by gavage during the period of organogenesis only.
No adequate and well-controlled studies have been conducted in pregnant women. Strattera should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus.
Labour and Delivery: Parturition (gestational length or live birth indices) in rats was not affected by atomoxetine. The effect of Strattera on labour and delivery in humans is unknown.
Use in Lactation: Atomoxetine and/or its metabolites are excreted in the milk of rats. It is not known if atomoxetine is excreted in human milk. Treatment of rats with atomoxetine prior to mating through the periods of organogenesis and lactation was associated with adverse effects on pups (see Use in Pregnancy & Lactation). Caution should be exercised if Strattera is administered to a nursing woman.