United Kingdom. Sucralfate, a complex of aluminium hydroxide and sulfated sucrose, is used in the treatment of duodenal and gastric ulcer and chronic gastritis. The suspension formulation (Antepsin Suspension) is also used in the prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients.

Seven reports have been received worldwide of bezoar (an insoluble mass formed within the gastric lumen) associated with sucralfate use in intensive care patients, including premature infants. In addition, a publication from a French study in newborn infants who received sucralfate revealed that 73% developed severe digestive problems and 36% presented with an occlusive syndrome requiring medical treatment.

Doctors should be aware of the risks of bezoar formation and potential intestinal obstruction with sucralfate in seriously ill patients, especially those receiving concomitant enteral feeds or who have predisposing conditions such as delayed gastric emptying. Sucralfate is not recommended for premature infants.

References:

1) Current Problems in Pharmacovigilance Vol. 25, March 1999.
2) XXXI Congress of the Paediatrics Association of French Speaking Language, Paris, 1-4 May 1996. Le Boude S. Proceedings and Abstracts. Archives de Pédiatrie: 3 Suppl 1: 1s-448s (1996).