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

 

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary

 

Safety Announcement

[03-29-2011] The U.S. Food and Drug Administration (FDA) is alerting the public to important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate) capsules. Due to the potential for product breakdown from moisture and loss of potency, Pradaxa capsules should only be dispensed and stored in the original bottle or blister package and patients should be aware of the specific handling requirements.

 

Facts about Pradaxa
  • An anticoagulant (or blood thinner) medication known as a direct thrombin inhibitor. It works by preventing the formation of blood clots. 
  • Used to help prevent strokes or serious blood clots in people who have non-valvular atrial fibrillation (irregular heart beat), a condition that increases the chance of clots forming in the body, which can lead to a stroke.1
  • From October 2010 through January 2011, approximately 128,000 Pradaxa prescriptions were dispensed and approximately 86,000 patients filled Pradaxa prescriptions from the outpatient retail pharmacies in the U.S.2 

The Pradaxa label and Medication Guide contain information about these special storage and handling requirements, but FDA is concerned that these requirements are not commonly known and are not being followed by Pradaxa users and by pharmacies. 

We are aware that many consumers use pill boxes or pill organizers to aid them in remembering to take their medications. However, because of the potential for product breakdown and loss of potency, consumers should not store Pradaxa in any container other than the original manufacturer packaging. Additionally, pharmacists should only dispense Pradaxa capsules in the original manufacturer packaging. Using the manufacturer packaging will minimize product breakdown from moisture. Pradaxa is packaged in a bottle containing a 30-day supply with a desiccant (drying agent) in the cap to help keep moisture away from the capsules. Pradaxa capsules are also available in a blister package which protects from moisture.

Although the current Pradaxa label states that the product should be discarded 30 days after the original bottle is opened, data currently under review by the FDA indicate that the product maintains 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.

 

Additional Information for Patients

  • 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.
    • Remove only one capsule from the bottle at the time of use. The bottle should be immediately closed tightly.
    • Date the bottle to expire 60 days after opening.
  • 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 using the information in the "Contact Us" box at the bottom of the page.

 

Additional Information for Healthcare Professionals

 

  • Tell patients it is important to follow the special storage and handling requirements for Pradaxa.
  • Tell patients that Pradaxa must be kept in the original bottle or blister package to protect from moisture. The bottle contains a dessicant in the cap and the blister package protects unopened pills from moisture.
  • Tell patients that Pradaxa capsules must not be stored in pill boxes or pill organizers.
  • Pharmacists should only dispense Pradaxa in the original manufacturer bottle with the original dessicant cap. Do not repackage Pradaxa capsules in standard amber pharmacy vials.
  • Pharmacists should not open the Pradaxa bottle when dispensing. When more than one bottle is dispensed, tell the patient to only open one bottle at a time.
  • Pharmacists should place an auxiliary expiration label on the bottle and instruct the patients to date the bottle to expire 60 days after opening.
  • Pharmacists can also number the bottles (e.g., bottle #1 and bottle #2) when dispensing multiple bottles so the patient can keep track of which bottle they opened.3
  • Report adverse events involving Pradaxa to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

 

Data Summary

 

Pradaxa was approved by the FDA on October 19, 2010, with special storage and product handling requirements. Pradaxa capsules will hydrolyze over time when exposed to humidity, causing a breakdown of active ingredient, and rendering the medication less effective. As a result, Pradaxa was packaged in a 30-day supply bottle with a desiccant cap or in unit-of-use blister packaging to minimize product breakdown from moisture. The approved Pradaxa label states that once opened, the product must be used within 30 days. FDA is currently reviewing data that indicate no significant loss of potency up to 60 days after the bottle is opened as long as Pradaxa is stored in the original bottle and the handling requirements are met. The current Pradaxa label and Medication Guide contains information about these special storage and product handling requirements.

FDA is concerned that these special storage and handling requirements are not commonly known and are not being followed by Pradaxa users and by pharmacies. Boehringer Ingelheim Pharmaceuticals, Inc., the manufacturer of Pradaxa, has started a campaign to educate healthcare professionals (prescribers and pharmacists) about these requirements. FDA is emphasizing that healthcare professionals must also reinforce the importance of following these special storage and handling requirements to their patients.

 

References

  1. U.S. National Library of Medicine. National Institutes of Health. Drugs & Supplements monograph. Available at http://www.nlm.nih.gov/medlineplus/druginfo/meds/a610024.html Accessed March 8, 2011.
  2. SDI, Vector One®: National (VONA) and Total Patient Tracker (TPT). October 2010 to January 2011. Extracted 3-8-2011.
  3. Pradaxa capsules have short expiration date after bottle opened. ISMP Medication Safety Alert Acute Care. Volume 16, Issue 4; February 24, 2011.

 

 

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