Reproduction studies performed in mice at oral doses up to 5,000 times (20 mg/kg/day) and in rats and rabbits at oral doses up to 2,500 times (10 mg/kg/day) the human topical dose have revealed no evidence of teratogenicity due to Voltaren despite the induction of maternal toxicity and fetal toxicity. In rats, maternally toxic doses were associated with dystocia , prolonged gestation, reduced fetal weights and growth, and reduced fetal survival. Voltaren has been shown to cross the placental barrier in mice and rats. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
In an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at mg/kg/day (94 times the human systemic exposure following topical ophthalmic administration of bimatoprost % to the cornea or conjunctival sac bilaterally once daily , based on AUC. The No Observed Adverse Effect Level (NOAEL) for abortion was mg/kg/day (estimated at 47 times the human systemic exposure following topical ophthalmic administration of bimatoprost % to the cornea or conjunctival sac bilaterally once daily based on AUC). No abnormalities were observed in rat fetuses at doses up to mg/kg/day.
The data described below reflect exposure to AzaSite in 698 patients. The population was between 1 and 87 years old with clinical signs and symptoms of bacterial conjunctivitis. The most frequently reported ocular adverse reaction reported in patients receiving AzaSite was eye irritation. This reaction occurred in approximately 1-2% of patients. Other adverse reactions associated with the use of AzaSite were reported in less than 1% of patients and included: burning, stinging and irritation upon instillation, contact dermatitis, corneal erosion, dry eye, dysgeusia, nasal congestion, ocular discharge, punctate keratitis, and sinusitis.