Csm advice

The Committee on Safety of Medicines (CSM) received 116 spontaneous reports of 197 adverse reactions between September 1995 and March 1996. Ten of these reactions involved the oesophagus: oesophageal reflux (4), oesophagitis (4), and oesophageal ulceration (2). Adverse gastrointestinal reactions are more common when this drug is used in conjunction with aspirin and NSAIDs.

The CSM recommend that the risk of oesophageal reactions should be minimised by:

• taking a full glass of plain water after taking the alendronate sodium
• patients taking alendronate sodium should not lie down for at least 30 minutes after taking tablets and until they have consumed the first meal of the day.
• patients should not take the medication before getting up in the morning or at bedtime.

Alendronate sodium should not be given to patients with:

• abnormalities of the oesophagus, or,
• factors that delay oesophageal emptying

Cautious use of alendronate sodium is required for patients with upper gastrointestinal problems.