Alendronate Sandoz Use In Pregnancy & Lactation

Pregnancy: There are no or limited amount of data from the use of alendronate in pregnant women.
Studies in animals have shown reproductive toxicity. Alendronate given during pregnancy in rats caused dystocia related to hypocalcaemia (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions). Alendronate should not be used during pregnancy.
Breast-feeding: It is unknown whether alendronate/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Alendronate should not be used during breastfeeding.
Fertility: Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. The amount of bisphosphonate incorporated into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the dose and duration of bisphosphonate use (see PHARMACOLOGY: Pharmacokinetics under Actions). There are no data on foetal risk in humans. However, there is a theoretical risk of foetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on the risk has not been studied.