Fosamax

[Alendronate]

Maternotoxicity (late pregnancy deaths) occurred in the female rats treated with 15 mg/ kg/ day for varying periods of time ranging from treatment only during pre-mating to treatment only during early, middle, or late gestation; these deaths were lessened but not eliminated by cessation of treatment. Calcium supplementation either in the drinking water or by minipump could not ameliorate the hypocalcemia or prevent maternal and neonatal deaths due to delays in delivery; calcium supplementation IV prevented maternal, but not fetal deaths. There are no studies in pregnant women.

FOSAMAX should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Nursing Mothers

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It is not known whether alendronate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FOSAMAX is administered to nursing women.
Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Of the patients receiving FOSAMAX in the Fracture Intervention Trial (FIT), 71% (n= 2302) were 65 years of age and 17% (n= 550) were 75 years of age. Of the patients receiving FOSAMAX in the United States and Multinational osteoporosis treatment studies in women, the osteoporosis study in men, glucocorticoid-induced osteoporosis studies, and Paget's disease studies (see CLINICAL PHARMACOLOGY, Clinical Studies), 45%, 50%, 37%, and 70%, respectively, were 65 years of age or over. No overall differences in efficacy or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

SEE SIDE EFFECTS AND DRUG INTERACTIONS SECTION ALSO

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