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Etidronate Pregnancy and Breastfeeding Warnings

Etidronate is also known as: Didronel, Didronel IV

Etidronate Pregnancy Warnings

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 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.

Etidronate Breastfeeding 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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