Background Alendronate, an aminobisphosphonate and a selectiveinhibitor of osteoclast-mediated bone resorption, is used totreat osteoporosis in postmenopausal women and Paget's diseaseof bone. Aminobisphosphonates can irritate the upper gastrointestinalmucosa.
Methods We describe three patients who had severe esophagitisshortly after starting to take alendronate and also analyzeadverse esophageal effects reported to Merck, the manufacturer,through postmarketing surveillance.
Results As of March 5, 1996, alendronate had been prescribedfor an estimated 475,000 patients worldwide, and 1213 reportsof adverse effects had been received. A total of 199 patientshad adverse effects related to the esophagus; in 51 of thesepatients (26 percent), including the 3 we describe in case reports,adverse effects were categorized as serious or severe. Thirty-twopatients (16 percent) were hospitalized, and two were temporarilydisabled. Endoscopic findings generally indicated chemical esophagitis,with erosions or ulcerations and exudative inflammation accompaniedby thickening of the esophageal wall. Bleeding was rare, andstomach or duodenal involvement unusual. In patients for whomadequate information was available, esophagitis seemed to beassociated with swallowing alendronate with little or no water,lying down during or after ingestion of the tablet, continuingto take alendronate after the onset of symptoms, and havingpreexisting esophageal disorders.
Conclusions Alendronate can cause chemical esophagitis, includingsevere ulcerations, in some patients. Recommendations to reducethe risk of esophagitis include swallowing alendronate with180 to 240 ml (6 to 8 oz) of water on arising in the morning,remaining upright for at least 30 minutes after swallowing thetablet and until the first food of the day has been ingested,and discontinuing the drug promptly if esophageal symptoms develop.
Source Information
From the Division of Gastroenterology (P.C.G., K.K.W.) and the Department of Medicine (D.F.L.), Mayo Clinic and Foundation, Rochester, Minn.; Merck Research Laboratories, Rahway, N.J. (L.J.H., A.D., W.S., D.F., S.P.-T.); and the Divisions of General Internal Medicine (M.J.S.) and Gastroenterology (H.P.), University of South Florida, Tampa.
Address reprint requests to Dr. de Groen at the Division of Gastroenterology, Mayo Clinic and Foundation, 200 First St. S.W., Rochester, MN 55905.
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