Zirgan Pregnancy Warnings
This ophthalmic gel should be used during pregnancy only if the benefit outweighs the risk to the fetus; according to some experts, this drug should not be used unless there are no alternatives.
AU TGA pregnancy category: D
US FDA pregnancy category: C
Comments (UK):
-Women of childbearing age should use contraception.
-Men using this drug should be advised to use local contraceptive measure (i.e., condom) during therapy and for up to 3 months after the last dose.
Animal studies have revealed evidence of embryofetal toxicity, embryolethality, and teratogenicity after IV administration; fetal resorptions occurred in at least 85% of rabbits and mice administered 60 mg/kg/day and 108 mg/kg/day (10,000 times and 17,000 times the human ocular dose), respectively, assuming complete absorption. Fetal growth retardation, embryolethality, teratogenicity (including cleft palate, anophthalmia/microphthalmia, aplastic organs [kidney, pancreas], hydrocephaly, brachygnathia), and maternal toxicity were observed in rabbits; maternal/fetal toxicity and embryolethality were observed in mice, with hypoplasia of the testes and seminal vesicles and pathologic changes in the nonglandular region of the stomach occurring at 90 mg/kg/day IV (14,000 times the human ocular dose). There are no controlled data in human pregnancy.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
See references
