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Published: July 1998

Alendronate and Oesophageal Ulceration

Information on this subject has been updated. Read the most recent information.

Prescriber Update 16: 32–33
July 1998

Medsafe Editorial Team

Alendronate can be associated with oesophageal ulceration when dosing instructions are not strictly adhered to. Patients should be advised to swallow alendronate tablets with > 200mL plain water after rising for the day. Food should not be eaten until 30 minutes after taking the medicine. Patients should not lie down for at least 30 minutes and not until they have eaten their first food for the day.

Alendronate sodium (Fosamax) is a bisphosphonate used for the treatment of osteoporosis in postmenopausal women and Paget’s disease of the bone. It has been found to cause severe oesophageal ulceration, particularly if it is used without strict adherence to the dosing instructions. The Centre for Adverse Reactions Monitoring holds 2 reports of oesophagitis with alendronate, and the WHO database has 330 reports of oesophagitis, 125 of oesophageal ulceration and 1 of oesophageal ulceration with haemorrhage.

Oesophagitis occurs when dosing instructions not followed

In a review1 of 199 cases of oesophagitis among 475,000 patients worldwide, 34 had oesophageal effects that were classified as serious or severe (32 were hospitalised and 2 temporarily disabled). Of 20 patients for whom information was available on the extent of the lesions, 5 had panoesophageal effects. 16/30 patients had taken the medicine with < 180 mL of water, and 18/33 had not remained upright for ≥ 30 minutes after taking the tablet. 11/28 appeared to have taken the tablet correctly, but 5 of these had other factors that may have increased the risk of oesophagitis, including a history of oesophagitis.

However, a prospective review2 of 994 patients in a clinical trial found no evidence of a difference in rate of serious or severe oesophageal effects between the alendronate and placebo groups. The important factor limiting the rate of oesophageal effects appears to have been the frequent follow-up visits and reinforcement of dosing instructions in the trial.

It is postulated that the oesophageal ulceration is caused by direct oesophageal irritation, and possibly reflux of gastric contents containing alendronate.

Tablets should be taken with > 200mL water

In order to minimise the risk of oesophageal damage, and maximise absorption, patients taking alendronate should be advised to adhere rigidly to the following dosing instructions. The instructions should be reinforced at each visit and given to the patient in writing (e.g. a copy of this article or the entry in New Ethicals Compendium).

Alendronate contraindicated with abnormalities of oesophagus

Because of the additional risk of oesophageal injury, alendronate is contraindicated in patients with abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia, or those who are unable to stand or sit upright for at least 30 minutes.

References
  1. De Groen PC, Lubbe DF, et al. Esophagitis associated with the use of alendronate. N Eng J Med 1996;335:1016-21.
  2. Liberman UA, Hirsch LJ. Esophagitis and alendronate. N Eng J Med 1996;335:1069-70.

 

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