Pradaxa (dabigatran etexilate mesylate) Capsules Storage Instructions From the FDA

Pradaxa (dabigatran etexilate mesylate) Capsules 

Storage Instructions From the FDA

Pradaxa capsules should only be dispensed and stored in their original bottle or blister package, and patients should follow specific handling requirements.

Facts about Pradaxa

• Pradaxa is an anticoagulant (blood thinner) known as a direct thrombin inhibitor, which prevents the formation of blood clots.
• It is used to help prevent strokes or serious blood clots in people with non-valvular atrial fibrillation (an irregular heartbeat), a condition that increases the risk of clot formation and stroke.
• Between October 2010 and January 2011, around 128,000 Pradaxa prescriptions were dispensed, with approximately 86,000 patients filling these prescriptions at outpatient retail pharmacies in the U.S.
• The Pradaxa label and Medication Guide provide information on special storage and handling requirements, but the FDA is concerned that these guidelines are not widely known or followed by Pradaxa users and pharmacies.

Many consumers use pill boxes or organizers to help them remember to take their medications. 

However, due to the risk of product degradation and potency loss Pradaxa should not be stored in any container other than its original manufacturer packaging. Keeping Pradaxa capsules in pillboxes can cause it to lose potency increasing the risk of stroke for the patients.

Pharmacists should also dispense Pradaxa capsules only in the original packaging to prevent moisture-related breakdown. Pradaxa bottles contain a 30-day supply with a desiccant (drying agent) in the cap to protect the capsules from moisture. Pradaxa capsules are also available in blister packages, which offer similar protection.

Source: FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules | FDA