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Pamidronate Pregnancy and Breastfeeding Warnings

Pamidronate is also known as: Aredia

Pamidronate Pregnancy Warnings

Pamidronate has been assigned to pregnancy category D by the FDA. Animal studies using bolus intravenous pamidronate revealed evidence of maternal toxicity and embryo/fetal effects when administered during organogenesis at doses 0.6 to 8.3 times the highest recommended human dose for a single IV infusion. Pamidronate crosses the placenta in animals and has produced nonteratogenic effects. There are no controlled data in human pregnancy. Pamidronate is considered contraindicated during pregnancy.

Animal studies using oral pamidronate doses of 25 to 100 mg/kg failed to reveal evidence of fetotoxicity or teratogenicity. Daily oral doses of 60 to 150 mg/kg increased the length of gestation and parturition, causing an increase in pup mortality.

Pamidronate Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

A 2000 study demonstrated that pamidronate 30 mg intravenously produced very low levels in breast milk, so absorption by a breastfed infant is unlikely. Withholding nursing for 12 to 24 hours after a dose should ensure little or no exposure of the breastfed infant to pamidronate.

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