Important safety information regarding Pradaxa (dabigatran)

 

Important safety information was released recently by the US Food and Drug Administration (FDA) regarding Pradaxa (dabigatran), a drug used to prevent blood clots in people with atrial fibrillation, a type of abnormal heart rhythm. The consumer alert notified patients who are taking this drug to be aware of its special storage and handling needs.

Pradaxa capsules are only to be dispensed and stored in the original bottle (with a desiccant-drying agent in the cap) or blister package. The reason for this precaution is that Pradaxa is made from substances that easily absorb and retain moisture. If not stored properly, this drug will easily breakdown and loose its potency, making the drug less effective.

The FDA reported concerns that these special storage requirements are not commonly known and are not being followed by Pradaxa users and by pharmacies. This means pharmacists may unknowingly dispense Pradaxa in generic vials or consumers may use pill storage containers to store separate pills. It is important for those who use this drug to be alerted to this important safety need.

The FDA is also alerting consumers that although the current Pradaxa label states that the product should be discarded 30 days after the original bottle is opened, recent data suggests the product can maintain its potency longer. The FDA indicates the product can maintain its potency up to 60 days after bottle opening as long as it is stored in the original bottle and the handling requirements are met--including that the cap is closed tightly after each use and the bottle is kept away from excessive moisture, heat, and cold. The manufacturer is gathering more information on whether the product can be used after 60 days and this information will be added to the Pradaxa label when FDA's review is complete.

The FDA offers the following suggestions for consumers taking Pradaxa: 

  • Store Pradaxa in the original bottle or blister package to protect from moisture.
  • Do not store or place Pradaxa capsules in any other container, such as pill boxes or pill organizers.
  • For Pradaxa bottles: 
  • Open only one bottle of Pradaxa at a time. Once the bottle is opened, the product must be used within 60 days. *the current label states 30 days, but an extension to 60 days is expected shortly.
  • Remove only one capsule from the bottle at the time of use. The bottle should be immediately closed tightly.
  • Bottles should note that the capsules should not be used beyond 60 days.
  • For Pradaxa blister packages:
  • Open the blister package at time of use. Do not open or puncture the blister any earlier than the time of use.
  • Discuss any questions or concerns about Pradaxa with your healthcare professional.
  • Read the Medication Guide for Pradaxa each time you get your prescription refilled.
  • Report any side effects you experience to the FDA MedWatch  program.                               
Created on March 30, 2011

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