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Micromedex(tertiary source) http://www.thomsonhc.com/micromedex2/librarian/ND_T/evidencexpert/ND_PR/evidence xpert/CS/5D394E/ND_AppProduct/evidencexpert/DUPLICATIONSHIELDSYNC/D25953/ND_P G/evidencexpert/ND_B/evidencexpert/ND_P/evidencexpert/PFActionId/evidencexpert.Inte rmediateToDocumentLink?docId=2038&contentSetId=51&title=BISPHOSPHONATES&service sTitle=BISPHOSPHONATES&topicId=clinicalEffectsSection BISPHOSPHONATES Gastrointestinal SUMMARY A) The most common adverse effects reported with bisphosphonate therapy are gastrointestinal disturbances (nausea, diarrhea, abdominal pain, and taste perversion). Potentially more serious effects have included ulcerations of the gastrointestinal tract. 3.8.2) CLINICAL EFFECTS A) GASTROINTESTINAL COMPLICATION 1) WITH THERAPEUTIC USE a) Gastrointestinal adverse effects are commonly reported following bisphosphonate therapy. Effects can include: nausea, diarrhea (etidronate), and gastrointestinal (esophageal, duodenal, and stomach) ulcers with second and third generation bisphosphonates. Other symptoms may include: abdominal pain, vomiting, and esophagitis/gastritis. b) In a review of adverse effects reported following bisphosphonate use, the incidence of corrosive esophagitis is low; however, when complications occur they tend to be severe(Lanza, 1998). RISK FACTORS : Patient's with a history of chronic reflux esophagitis, Barrett's mucosa, and patients with motility or stricture disease should avoid therapy with bisphosphonates . Also, patients that are debilitated or bedridden may be at greatest risk for gastrointestinal complications following therapy. (Lanza, 1998). c) ALENDRONATE In clinical studies adverse experiences were similar for patients taking alendronate 40 mg/day (Paget's disease) and 10 mg/day (postmenopausal women) except for upper gastrointestinal adverse effects (17.7% with alendronate and 10.2% placebo)(Prod Info FOSAMAX(R) oral tablets, solution, 2010) . PUBMED (secondary source) http://www.ncbi.nlm.nih.gov/pubmed/11048968 Alendronate-related oral mucosa ulcerations. Gonzalez-Moles MA, Bagan-Sebastian JV. Abstract Alendronate is widely used in the treatment of osteoporosis and other bone diseases. Although it is considered a well-tolerated drug, there are numerous reports of adverse effects on the mucosa in the upper aerodigestive tract, with oesophagitis as the most common complication. The strict regulations for the proper administration of the drug indicate that these side effects might well be the result of a direct, irritant mechanism on the upper aerodigestive tract. We present two clinical cases of patients who developed extensive palatal ulcers as a result of taking alendronate. We discuss possible mechanisms implicated in the production of the ulcers and some clinical factors of interest. Keyword: bisphosphonate and ulcer Google search Upper Gastrointestinal Adverse Reactions FOSAMAX, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when FOSAMAX is given to patients with active upper gastrointestinal problems (such as known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis,duodenitis, or ulcers). Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophagealstricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates including FOSAMAX. In some cases these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue FOSAMAX and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates including FOSAMAX and/or who fail to swallow oral bisphosphonates including FOSAMAX with the recommended full glass (6-8 oz) of water, and/or who continue to take oral bisphosphonates including FOSAMAX after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient [see DOSAGE AND ADMINISTRATION]. In patients who cannot comply with dosing instructions due to mental disability, therapy with FOSAMAX should be used under appropriate supervision. There have been post-marketing reports of gastric and duodenal ulcers with oralbisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials http://www.rxlist.com/fosamax-drug/warnings-precautions.htm Key word: alendronate/esophagitis alendronate administration via oral route can local irritation of the upper gastrointestinal mucosa. The most common adverse effects reported with bisphosphonate therapy are nausea,vomiting, diarrhea and abdominal pain. Potentially more serious effects have included ulcerations of the gastrointestinal tract such as esophagitis.