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Previous Volume 335:1016-1021 October 3, 1996 Number 14 Next

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ABSTRACT

Background Alendronate, an aminobisphosphonate and a selective inhibitor of osteoclast-mediated bone resorption, is used to treat osteoporosis in postmenopausal women and Paget's disease of bone. Aminobisphosphonates can irritate the upper gastrointestinal mucosa.

Methods We describe three patients who had severe esophagitis shortly after starting to take alendronate and also analyze adverse esophageal effects reported to Merck, the manufacturer, through postmarketing surveillance.

Results As of March 5, 1996, alendronate had been prescribed for an estimated 475,000 patients worldwide, and 1213 reports of adverse effects had 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 serious or severe. Thirty-two patients (16 percent) were hospitalized, and two were temporarily disabled. Endoscopic findings generally indicated chemical esophagitis, with erosions or ulcerations and exudative inflammation 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 associated with swallowing alendronate with little or no water, lying down during or after ingestion of the tablet, continuing to take alendronate after the onset of symptoms, and having preexisting esophageal disorders.

Conclusions Alendronate can cause chemical esophagitis, including severe ulcerations, in some patients. Recommendations to reduce the risk of esophagitis include swallowing alendronate with 180 to 240 ml (6 to 8 oz) of water on arising in the morning, remaining upright for 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.

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.

Full Text of this Article

Related Letters:

Esophagitis and Alendronate
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N Engl J Med 1996; 335:1069-1070, Oct 3, 1996. Correspondence

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