| Theme | Progress in the management of phosphorus in chronic kidney disease | |
|---|---|---|
| Title | Side effects and safety usage of sevelamer hydrochloride | |
| Publish Date | 2004/10 | |
| Author | Satoshi Kurihara | Kasukabe Naika Clinic |
| [ Summary ] | Sevelamer hydrochloride is a polycation polymer, free of both calcium and aluminum. This agent is used as a new type of phosphate binder with minimal side effects. In Japanese clinical studies (Phases I, II, and III), adverse events were seen in 229 of 343 patients (66.8%). The most frequent adverse events were gastrointestinal disturbances (205/343 subjects, 59.8%), abnormal changes in laboratory and physiological data (39/343, 11.4%), along with metabolic and nutritional disturbances (23/343, 6.7%). The most prevalent gastrointestinal disturbances, included constipation (38.2%), abdominal pain (16.6%), abdominal fullness (14.6%), nausea (7.3%), etc. These gastrointestinal events usually were noted during the first 4 weeks from the start of administrafion, and the frequency of the events depended on dosage. More recent research, conducted after the market release of sevelamer hydrochloride (from June to December, 2003) identified a high frequency of ileus (16 subjects) and perforations of the intestinal tract (8 subjects), an extremely serious gastrointestinal disorder. These gastrointestinal symptoms are caused by the expansion of the sevelamer as it adsorbs water in the intestinal tract. We should carefully watch for these gastrointestinal symptoms and administer prompt treatment if they are observed. |
|