FDA Warns Against Repackaging Anticoagulant

April 5, 2011
Laura Enderle Associate Editor

Pharmacists should take careful note of handling guidelines for Boehringer Ingelheim's new blood thinner Pradaxa.

Pharmacists should take careful note of handling guidelines for Boehringer Ingelheim’s new blood thinner Pradaxa.

A warning from the FDA regarding Boehringer Ingelheim’s Pradaxa (dabigatran etexilate mesylate) may prompt questions from patients about the drug’s proper storage and handling. According to the agency, Pradaxa should be kept in its original manufacturer bottle or blister pack to protect it from breakdown caused by exposure to moisture.

The anticoagulant was approved on October 19, 2010, and is indicated for the reduction of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Between October 2010 and January 2011, US retail pharmacies filled approximately 86,000 prescriptions for the drug, according to the FDA.

Although Pradaxa’s product label and medication guide communicates the special handling requirements, FDA officials expressed concern that best practices are not widely known or followed by patients and pharmacists. In the safety alert issued Tuesday, March 29, 2011, FDA provided the following dos and don’ts to ensure product integrity:

DO:

  • Dispense and store Pradaxa capsules only in their original blister pack or manufacturer bottle with dessicant cap
  • Use Pradaxa capsules within 60 days after the bottle is open
  • Report adverse events or safety concerns to the FDA’s MedWatch Reporting Program

DON’T:

  • Repackage Pradaxa capsules in standard amber vials
  • Store or place Pradaxa capsules in a pill box, travel container, or other medication organizer
  • Open more than 1 bottle of Pradaxa capsules at a time

The recommendation to use the drug within 60 days differs from the drug’s original limit of 30 days. The longer period is based on new trial 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,” FDA wrote.

For more information on Pradaxa, including information on its pharmacology and pharmacokinetics, clinical trials, dosing and precautions, view the drug’s in-depth profile, published in the December 2010 issue of Pharmacy Times, at http://phrmcyt.ms/dVAfZp.

For other articles in this issue, see:

  • New Online Home for Pharmacists Goes Live at PharmacyTimes.com
  • Quick Treatment Critical for Kids With Pneumonia
  • Drug Shortages Hurt Hospitals, Undermine Care