Safety Information

Trans-Tasman Early Warning System - Alert Communication

Pradaxa (dabigatran etexilate) and oesophageal ulcer

Products affected
Information for consumers and caregivers
Information for healthcare professionals
Data summary
What action is Medsafe taking?
How to report
Further information

Pradaxa is a ‘blood thinner’. It helps stop blood clots forming after surgery. It is also used to stop blood clots and strokes in patients with an abnormal heart beat (atrial fibrillation). Pradaxa is known to be associated with the development of ulcers in the digestive tract. However, recent case reports have highlighted that Pradaxa can also cause the development of ulcers in the oesophagus (food pipe). The risk of developing oesophageal ulcers can be minimised by always taking Pradaxa with food and a full glass of water.

Products affected

This alert applies only to Pradaxa (dabigatran etexilate) manufactured by Boehringer Ingelheim.

Information for consumers and caregivers

Always take Pradaxa with food and a full glass of water to help the capsule get to your stomach.
If you have problems swallowing the capsule or start to get heart burn after starting Pradaxa you should go back to your doctor to ask for further advice.
Do not stop taking your medicine unless advised to do so by your doctor, this will put you at risk of having a blood clot.
Make an appointment to see your doctor if you have any concerns.
Report any adverse events to the Centre for Adverse Reactions Monitoring (CARM).

Information for healthcare professionals

Advise all patients to take Pradaxa with food and a full glass of water. This minimises the risk of the capsule getting stuck in the oesophagus and causing contact ulceration.
Assess patients complaining of new onset symptoms of gastro-oesophageal reflux after starting Pradaxa to ensure they are taking Pradaxa correctly.
An alternative anticoagulant may be needed in patients with swallowing difficulties.
Pradaxa is not suitable for patients with nasogastric tubes and the capsules should not be opened.
Report any suspected adverse reactions to the Centre for Adverse Reactions Monitoring (CARM).

Data summary

Three clusters of case reports of oesophageal ulcer have been reported to Boehringer Ingelheim from around the world.

Patients experiencing swallowing difficulties or feeling that the capsule was stuck. It was noted that many of these patients had taken the capsule with very little water and/or lay down shortly after taking the capsule.
Patients who developed gastro-oesophageal reflux disease.
Incorrect administration of the capsules, in particular opening or breaking the capsule and ingestion of the pellets.

In addition, cases of positive re-challenge have been reported. Three similar cases have been reported in New Zealand to the Centre for Adverse Reactions Monitoring (CARM).

What action is Medsafe taking?

Boehringer Ingelheim has updated the data sheet for Pradaxa. Medsafe continues to monitor the safety of Pradaxa, as for all medicines.

How to report

Online	Submit a CARM report Prescribers can also submit a report using the online reporting tool available in patient management software.
Paper	Download a consumer reporting form (Word Document, 61KB, 1 page) Download a healthcare professional reporting form (PDF, 292 KB, 2 pages) Submit completed forms by emailing CARMreport@health.govt.nz or mail (Medsafe, Ministry of Health, 133 Molesworth Street, Thorndon, Wellington, 6011).
Email	CARMreport@health.govt.nz