Ganirelix acetate Pregnancy Warnings
Use is contraindicated
AU TGA pregnancy category: D
US FDA pregnancy category: X
Comments: Alterations in hormonal levels caused by this drug could result in fetal loss and therefore, this drug is contraindicated in pregnant women.
Administration to rats and rabbits from day 7 to near term at doses approximately 0.4 to 3.2 times the human dose based on body surface area, increased the incidence of litter resorption. No increase in fetal abnormalities and no treatment-related changes in fertility, physical, or behavior characteristics were observed in the offspring of female rats during pregnancy and lactation. 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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
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