21817 Biphosphonates and other osteoporosis drugs

Pharmacology and toxicology

Alendronate acid, clodronic acid, etidronic acid, ibandronic acid, pamidronic acid, risedronic acid, tiludronic acid and zoledronic acid arc among the osteolysis inhibitors. They are used for Morbus Paget, postmenopausal osteoporosis, and other osteolytic processes. There are no systematic studies on their use during pregnancy. Animal experiments suggest a possible placental transfer and effect on fetal skeletal development (Omoy 1998).

In one study, there was no major congenital anomaly among 24 pregnancies with pre-pregnancy or early pregnancy exposure to alendronate (Ornoy 2006). Another case report describes a healthy newborn, with normal bone structure and uneventful development until the age of 1 year, who was exposed to 10 mg per day throughout pregnancy (Rutgers Aferhagc 2003). Another report was on a woman receiving zoledronic acid during the second and third trimesters, after chemotherapy for breast cancer during the first trimester. The child was born at 35 weeks' gestation, and was followed until the age of 1 year, during which time development was normal (Andreadis 2004).

A prospective study covering 15 pregnancies where the mothers underwent biphosphonate treatment (alendronate acid, 7; etidronic acid, 5; pamidronic acid, 1; risedronic acid, 2), and where 9 of the mothers were being treated during the first trimester, resulted in 14 live births and 1 spontaneous abortion. There was no indication of developmental toxicity (Levy 2004).

There are insufficient data on the use of calcitonin, cinacalet, and raloxifen during pregnancy.

Recommendation. Biphosphonates and the other osteoporosis drugs are not indicated during pregnancy. Accidental acute use of individual doses in the first trimester does not justify either interruption of the pregnancy or additional diagnostic procedures.

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