Prevent oesophagitis when using dabigatran

Oesophagitis is a known adverse drug reaction (ADR) of the direct acting oral anticoagulant dabigatran (Pradaxa®). The Netherlands Pharmacovigilance Centre Lareb has received 33 reports of oesophageal complaints. In some of these reports it was mentioned that the complaints occurred, also when dabigatran was taken as advised together with water. It seems that this instruction is insufficient to prevent oesophagitis and related complaints. The literature advices that dabigatran should be taken with plenty of water and that the patient remains in standing or sitting position for at least 30 minutes. 

Medication induced oesophagitis can be caused by pill retention in the oesophagus and direct contact with the mucosa. Dabigatran capsules contain dabigatran etexilate (pro-drug) pellets with a core of tartaric acid that can cause local irritation of the oesophageal mucosa. 

The treatment of dabigatran induced oesophagitis consists of withdrawing the dabigatran and add a proton-pump inhibitor to the treatment. After dabigatran withdrawal, the complains will usually resolve within 7-10 days. The prognosis is good, 92% of the cases described in the literature recovered. 

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