PDR Health Blog

For those of you out there that have spent weeks, months, or years slaves to routine INR testing and all of the Coumadin “rules,” you must be breathing a huge sigh of relief with the recent approval of Pradaxa.

In late 2010, the FDA approved Pradaxa capsules for the prevention of stroke and blood clots in people with an abnormal heart rhythm known as atrial fibrillation. For years, Coumadin was the drug of choice for people with atrial fibrillation and required routine monitoring. Unlike its predecessor, Pradaxa does not require periodic monitoring.

As a result of the potential for product breakdown from moisture and loss of potency, the FDA recently issued a safety alert for people taking Pradaxa regarding important special storage and handling instructions:

• Pradaxa capsules should only be dispensed and stored in the original manufacturer bottle or blister package
• Patients should not store Pradaxa in any other container, such as a pill box
• Pradaxa should  be stored at room temperature

For Pradaxa bottles:

• When more than one bottle is dispensed, open only one bottle of Pradaxa at a time
• Remove only one capsule from the bottle at a time and immediately close tightly
• After opening, use Pradaxa within 30 days
• Date the bottle with a 30 day expiration date
• Safely discard any unused Pradaxa after 30 days

For Pradaxa blisters:

• Blisters should be stored and dispensed in original package
• Only remove capsule from blister at time of use
• Do not open or puncture blister earlier than time of use

The Bottom Line about Pradaxa

• Pradaxa is for the prevention of stroke and blood clots in people with atrial fibrillation
• The most common side effects are gastritis-like symptoms (upset stomach, stomach pain, nausea, heartburn, bloating) and bleeding
• Pradaxa is available in 75 mg and 150 mg capsules
• Pradaxa is manufactured by Boehringer Ingelheim Pharmaceuticals