Dabigatran (Pradaxa) storage issues

Published in Health News and Evidence

Date published: About this date

Clinical content may change after this date. This information is not intended as a substitute for medical advice from a qualified health professional. Health professionals should rely on their own expertise and enquiries when providing medical advice or treatment.

Prescribers and pharmacists are reminded that dabigatran (Pradaxa) capsules should be dispensed and stored in the manufacturer’s original packaging to protect from moisture.1–3 Repackaging dabigatran capsules increases the risk of exposure to moisture or humidity, causing product breakdown and loss of potency.

A US FDA Drug Safety Communication published in 20111 reinforces the issue in relation to adherence aids. Many consumers and dispensers use pill organisers to assist in ensuring medicines are taken on the correct days.  These should not be used to dispense dabigatran unless this can be achieved without removing the capsule from its original blister pack.

Pradaxa is currently supplied in blister packs or bottles. Ensure patients are advised that they should not take Pradaxa capsules after the expiry date printed on the packaging or if the packaging is torn or shows signs of tampering. For capsules supplied in bottles, once opened the bottle must be used within 4 months and kept tightly closed.

Capsules must also not be opened, chewed or crushed, as this may increase the oral bioavailability by as much as 1.8-fold (+75%), increasing the bleeding risk.3

For more information about dabigatran read the NPS RADAR articles on Dabigatran (Pradaxa) for preventing venous thromboembolism after hip or knee replacement surgery

and Dabigatran (Pradaxa) for stroke prevention in patients with non-valvular atrial fibrillation

  1. US Food and Drug Administration. FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules. 2011. http://www.fda.gov/Drugs/DrugSafety/ucm248746.htm (accessed 10 May 2013).
  2. Boehringer Ingelheim Pty Limited. Pradaxa capsules (dabigatran). Comsumer medicine information  2013. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2009-CMI-01176-3 (accessed 10 May 2013).
  3. Boehringer Ingelheim Pty Limited. Pradaxa (dabigatran etexilate) Product information. 2013. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2009-PI-01177-3 (accessed 10 May 2013).