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Side Effects & Drug Interactions
ADVERSE REACTIONS
Osteoporosis: ACTONEL has been studied in over 5700 patients enrolled in the Phase 3 glucocorticoid-induced osteoporosis clinical trials and in postmenopausal osteoporosis trials of up to 3-years duration. The overall adverse event profile of ACTONEL 5 mg in these studies was similar to that of placebo. Most adverse events were either mild or moderate and did not lead to discontinuation from the study. Text Continues Below
The incidence of serious adverse events in the placebo group was 24.9% and in the ACTONEL 5-mg group was 26.3%. The percentage of patients who withdrew from the study due to adverse events was 14.4% and 13.5% for the placebo and ACTONEL 5-mg groups, respectively. Table 5 lists adverse events from the Phase 3 osteoporosis trials reported in treated patients than placebo-treated patients. Adverse events are shown without attribution of causality. 
Duodenitis and glossitis have been reported uncommonly (0. 1% to 1%). There have been rare reports (< 0. 1%) of abnormal liver function tests. Laboratory Test Findings: Asymptomatic and small decreases were observed in serum calcium and phosphorus levels. Overall, mean decreases of 0.8% in serum calcium and of 2.7% in phosphorus were observed at 6 months in patients receiving ACTONEL. Throughout the Phase 3 studies, serum calcium levels below 8 mg/ dL were observed in 18 patients, 9 (0. 5%) in each treatment arm (ACTONEL and placebo). Serum phosphorus levels below 2 mg/ dL were observed in 14 patients, 11 (0. 6%) treated with ACTONEL and 3 (0. 2%) treated with placebo. Endoscopic Findings: ACTONEL clinical studies enrolled over 5700 patients, many with pre-existing gastrointestinal disease and concomitant use of NSAIDs or aspirin. Investigators were encouraged to perform endoscopies in any patients with moderate-to-severe gastrointestinal complaints, while
maintaining the blind. These endoscopies were ultimately performed on equal numbers of patients between the treated and placebo groups [75 (14.5%) placebo; 75 (11.9%) ACTONEL]. Across treatment groups, the percentage of patients with normal esophageal, gastric, and duodenal mucosa on endoscopy was similar (20% placebo, 21% ACTONEL). The number of patients who withdrew from the studies due to the event prompting endoscopy was similar across treatment groups. Positive findings on endoscopy were also generally comparable across treatment groups. Page: 1 | 2 | 3 | 4 | 5 | Next >>
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