Bisphosphonates

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Chapter: Pharmacovigilance: Gastrointestinal ADRs

The bisphosphonate group of drugs is used for the management of disorders typified by enhanced bone resorption such as Paget’s disease and osteoporosis.


BISPHOSPHONATES

The bisphosphonate group of drugs is used for the management of disorders typified by enhanced bone resorption such as Paget’s disease and osteoporosis. Alendronate, a drug that is indicated for the treatment of osteoporosis, has been associated with adverse oesophageal and gastric events. Case reports of oesophagitis, oesophageal ulcer and oesophageal stricture have been reported (Manconi and Bianchi Porro, 1995; Abdelmalek and Douglas, 1996; Colina et al., 1997, de Groen et al., 1996; Liberman and Hirsch, 1996; Naylor and Davies, 1996; Rimmer and Rawls, 1996; Kelly and Taggart, 1997; Levine and Nelson, 1997). Pamidronate also has been asso-ciated with oesophagitis (Lufkin et al., 1994).

In addition to causing oesophageal injury, it has been shown in endoscopic studies in volunteers that alendronate, and likely risedronate, can cause acute gastric mucosal damage and gastric ulceration (Graham, 2000). The incidence of adverse gastro-intestinal events in users of alendronate was assessed from computerised pharmacy claims of the United Health Group-affiliated health plans in the United States (Park et al., 2000). Over 1400 persons who received alendronate prescriptions were identified. Amongst those who had no prior oesophageal or gastric diagnoses, the cumulative incidence of upper gastrointestinal events was 3.3% in females, 2% in males and 3% overall. This included 22 patients with oesophagitis, 2 with oesophageal ulcer, 1 with gastric ulcer and 15 with gastritis/duodenitis.

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