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Dabigatran (Pradaxa®) and oesophageal injury

Date: 26 October 2015

Dabigatran is an oral anticoagulant. Dabigatran is used for thrombosis and thromboprophylaxis after total hip or knee replacement, as well as the prevention of strokes and thrombosis in patients with atrial fibrillation. Esophagitis is a known adverse drug reaction (ADR) of dabigatran. Lareb has received several reports of esophagitis and esophageal ulcer. Recently, several cases of dabigatran-induced esophagitis have been published in literature.

Dabigatran capsules contain a tartaric-acid core. It has been suggested that this core can cause local tissue damage after prolonged contact with the esophagus. In literature it is suggested that patients should be instructed to take dabigatran with sufficient water and remain in upright position after ingestion. Elderly patients are at higher risk for developing dabigatran-induced esophagitis and esophageal ulcer, because of less fluid intake, hyposalivation and being often in supine position. This increases the change of prolonged contact between the drug and the esophagus. The patient information leaflet recommends that the capsule should be swallowed whole with a glass of water, to ensure delivery to the stomach.

If a patient suffers from heartburn, upper abdominal pain or odynophagia during treatment with dabigatran, it should be recommended to see a doctor.

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