PREGNANCY SUMMARY

No reports describing the use of ibandronate in human pregnancy have been located. In one animal species, the drug caused growth restriction at doses ≤10 times the human dose, but maternal deaths at these doses also were observed. The lack of human pregnancy experience with ibandronate and the very limited human data for the bisphosphonate class prevent further assessment of the risk. The amount of drug retained in bone and eventually released back into the systemic circulation is directly related to the dose and duration of treatment. Because ibandronate probably crosses the placenta, treatment of the mother before conception could result in continuous exposure of the embryo and fetus to an unknown amount of drug. Moreover, animal data suggest that fetal bone has a greater uptake of bisphosphonates than maternal bone. Therefore, the use of ibandronate is not recommended in women who may become pregnant or during pregnancy. There is a theoretical risk of fetal harm (e.g., skeletal and other abnormalities) (1), but the magnitude of this risk cannot be estimated. Infants exposed in utero to ibandronate should be monitored for hypocalcemia during the first few days after birth.