Etidronate Pregnancy and Breast Feeding Warnings
Etidronate is also known as: Didronel, Didronel IV
Overview
It is not known if Etidronate can cause harm to the fetus. If you become pregnant while taking Etidronate contact your doctor. You will need to discuss the benefits and risks of using Etidronate while you are pregnant. It is not known if Etidronate is found in breast milk. If you are or will be breast-feeding while you are using Etidronate , check with your doctor. Discuss any possible risks to your baby.
Etidronate Pregnancy Warnings
Etidronate has been assigned to pregnancy category C by the FDA. Etidronate has been shown to cause skeletal abnormalities in rats when given at oral dose levels of 300 mg/kg (15 to 60 times the human dose). Other effects on the offspring (including decreased live births) are at dosages that cause significant toxicity in the parent generation and are 25 to 200 times the human dose. There are no controlled data in human pregnancy. Etidronate is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
Bisphosphonates are incorporated into the bone matrix, from where they are gradually released over periods of weeks to years. Therefore, there is a theoretical risk of fetal harm if a woman becomes pregnant after completing a course of bisphosphonate therapy. Animal studies using oral doses up to 100 mg/kg failed to reveal evidence of teratogenicity. However, at doses of 300 mg/day, skeletal malformations were noted in the offspring of rats. Skeletal effects are thought to be due to the pharmacological effect of the dug on bone. Doses 25 to 200 times the recommended human dose resulted in maternal toxicity and decrease in number of live births. There are no controlled animal pregnancy data with IV etidronate.
Etidronate Lactation Warnings
There are no data on the excretion of etidronate into human milk. The manufacturer recommends that caution be used when administering etidronate to nursing women.
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