Actonel

[Risedronate]

There was a higher number of reports of mild duodenitis in the ACTONEL group, however there were more duodenal ulcers in the placebo group. Clinically important findings (perforations, ulcers, or bleeding) among this symptomatic population were similar between groups (51% placebo; 39% ACTONEL).

Once-a-week Dosing: In a 1-year, double-blind, multicenter study comparing ACTONEL 5-mg daily and ACTONEL 35-mg once a week in postmenopausal women, the overall safety and tolerability profiles of the 2 oral dosing regimens were similar. Table 6 lists the adverse events in 2% of patients from this trial. Events are shown without attribution of causality.

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Paget's Disease:

ACTONEL has been studied in 392 patients with Paget's disease of bone. As in trials of ACTONEL for other indications, the adverse experiences reported in the Paget's disease trials have generally been mild or moderate, have not required discontinuation of treatment, and have not appeared to be related to patient age, gender, or race.

In a double-blind, active-controlled study, the adverse event profile was similar for ACTONEL and Didronel: 6.6% (4/ 61) of patients treated with ACTONEL 30 mg/ day for 2 months discontinued treatment due to adverse events, compared to 8. 2% (5/ 61) of patients treated with Didronel 400 mg/ day for 6 months.

Three patients who received ACTONEL 30 mg/ day experienced acute iritis in 1 supportive study. All 3 patients recovered from their events; however, in 1 of these patients, the event recurred during ACTONEL treatment and again during treatment with pamidronate. All patients were effectively treated with topical steroids.

Drug Interactions:

No specific drug-drug interaction studies were performed. Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (Cytochrome P450).

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