Fosamax

[Alendronate]

The adverse experience profile was similar for the 401 patients treated with either 5 or 20 mg doses of FOSAMAX in the United States and Multinational studies. The adverse experience profile for the 296 patients who received continued treatment with either 5 or 10 mg doses of FOSAMAX in the two-year extension of these studies (treatment years 4 and 5) was similar to that observed during the three-year placebo-controlled period.

During the extension period, of the 151 patients treated with FOSAMAX 10 mg/ day, the proportion of patients who discontinued therapy due to any clinical adverse experience was similar to that during the first three years of the study. In a one-year, double-blind, multicenter study, the overall safety and tolerability profiles of once weekly FOSAMAX 70 mg and FOSAMAX 10 mg daily were similar. The adverse experiences considered by the investigators as possibly, probably, or definitely drug related in 1% of patients in either treatment group are presented in the following table.

Text Continues Below

---

Men

In a two-year, placebo-controlled, double-blind, multicenter study, discontinuation of therapy due to any clinical adverse experience occurred in 2.7% of men treated with FOSAMAX 10 mg/ day and 10.5% of men treated with placebo. The adverse experiences considered by the investigators as possibly, probably, or definitely drug related in 2% of patients treated with either FOSAMAX 10 mg/ day or placebo are presented in the following table.

Prevention of osteoporosis in postmenopausal women The safety of FOSAMAX 5 mg/ day in postmenopausal women 40-60 years of age has been evaluated in three double-blind, placebo-controlled studies involving over 1,400 patients randomized to receive FOSAMAX for either two or three years. In these studies the overall safety profiles of FOSAMAX 5 mg/ day and placebo were similar. Discontinuation of therapy due to any clinical adverse experience occurred in 7.5% of 642 patients treated with FOSAMAX 5 mg/ day and 5.7% of 648 patients treated with placebo. In a one-year, double-blind, multicenter study, the overall safety and tolerability profiles of once weekly FOSAMAX 35 mg and FOSAMAX 5 mg daily were similar.

Page:  << Prev | 1 | 2 | 3 | 4 | Next >>