ESOPHAGITIS ASSOCIATED WITH THE USE OF ALENDRONATE

Background Alendronate, an aminobisphosphonate and a selective inhibit or of osteoclast-mediated bone resorption, is used to treat osteoporos is in postmenopausal women and Paget's disease of bone. Aminobisphosph onates can irritate the upper gastrointestinal mucosa. Methods We desc ribe three patients who had severe esophagitis shortly after starting to take alendronate and also analyze adverse esophageal effects report ed to Merck, the manufacturer, through postmarketing surveillance. Res ults As of March 5, 1996, alendronate had been prescribed for an estim ated 475,000 patients worldwide, and 1213 reports of adverse effects h ad been received. A total of 199 patients had adverse effects related to the esophagus; in 51 of these patients (26 percent), including the 3 we describe in case reports, adverse effects were categorized as ser ious or severe. Thirty-two patients (16 percent) were hospitalized, an d two were temporarily disabled. Endoscopic findings generally indicat ed chemical esophagitis, with erosions or ulcerations and exudative in flammation accompanied by thickening of the esophageal wall. Bleeding was rare, and stomach or duodenal involvement unusual. In patients for whom adequate information was available, esophagitis seemed to be ass ociated with swallowing alendronate with little or no water, lying dow n during or after ingestion of the tablet, continuing to take alendron ate after the onset of symptoms, and having preexisting esophageal dis orders. Conclusions Alendronate can cause chemical esophagitis, includ ing severe ulcerations, in some patients. Recommendations to reduce th e risk of esophagitis include swallowing alendronate with 180 to 240 m l (6 to 8 oz) of water on arising in the morning, remaining upright fo r at least 30 minutes after swallowing the tablet and until the first food of the day has been ingested, and discontinuing the drug promptly if esophageal symptoms develop. (C) 1996, Massachusetts Medical Socie ty.