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Reproduction toxicity studies with pamidronate.

P Graepel1, P Bentley, H Fritz

  • 1Ciba-Geigy Limited, Pharmaceuticals Division, Basel, Switzerland.

Arzneimittel-Forschung
|May 1, 1992
PubMed
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Pamidronate (disodium 3-amino-1-hydroxypropylidene-1,1-bisphosphonate pentahydrate) use in pregnancy is not advised due to risks of difficult labor and fetal skeletal issues, despite no teratogenic effects observed.

Area of Science:

  • Pharmacology and Toxicology
  • Reproductive Toxicology
  • Developmental Toxicology

Background:

  • Pamidronate is a bisphosphonate used to treat bone diseases.
  • Understanding its reproductive and developmental toxicity is crucial for patient safety.

Purpose of the Study:

  • To evaluate the reproductive and developmental toxicity of pamidronate in rats and rabbits.
  • To assess the effects of both oral and intravenous administration routes.

Main Methods:

  • Conducted Segment I, II, and III reproduction toxicity studies in rats and Segment II studies in rabbits.
  • Administered pamidronate orally and intravenously.
  • Monitored maternal toxicity, parturition, pup viability, and fetal development.

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Main Results:

  • Oral absorption of pamidronate was low (approximately 2%).
  • Maternal toxicity, including parturition difficulties and reduced pup viability, was observed in rats at high doses.
  • Fetal skeletal retardation and underdevelopment occurred in both species at doses ~10x human therapeutic levels.
  • No teratogenic effects or impact on reproductive performance were noted.

Conclusions:

  • Pamidronate use in pregnancy should be avoided due to potential adverse effects on parturition and fetal bone.
  • The drug crosses the placenta and binds to fetal bone, necessitating caution.
  • Use is only recommended when medically essential and no safer alternatives exist.