Pradaxa Recall Issued Over Defective Bottles, Effectiveness Concerns

Boehringer Ingelheim has issued a recall for one lot of the blood thinner Pradaxa, due to problems with the bottles, which may impact the effectiveness of the popular anticoagulant. 

The recall was issued earlier this week for one manufacturing lot of Pradaxa 75mg. The defective bottles have a packaging defect that could damage the pill’s quality, but there have been no reported adverse events associated with the recalled Pradaxa tablets.

According to the manufacturer, damaged bottles could let in moisture that may make the pills less effective.

In March 2011, the FDA issued a safety communication warning users not to take Pradaxa pills out of the bottles or their blister packages until they are ready to use the pill. The agency warned that taking the pills out early and placing them in a pill box or organizer may impact the effectiveness.

The drug has the potential to break down and lose potency, and must be used within 60 days even when kept in the original container without any defect.

The Pradaxa recall includes one manufacturing lot of 75mg pills *NDC 0597-0149-54, lot 201900), with an expiration date of January 2014. Boehringer Ingelheim has instructed pharmacists to contact patients who have the defective bottles and return them to the pharmacy for a free replacement.

Lawsuits Have Alleged a Recall for all Pradaxa Should Be Issued

Pradaxa (dabigitran) is an anticoagulant that was introduced by Boehringer Ingelheim in October 2010 for prevention of strokes in patients with atrial fibrillation.

The medication has been promoted as a superior alternative to warfarin (Coumadin), because it is easier to take and requires less monitoring.  However, it has been linked to a number of reports of severe bleeds and hemorrhages, as there is no antidote or reversal agent available to quickly stop the blood thinning effects of the medications.

Within the first year Pradaxa was on the market there were at least 2,367 adverse event reports submitted to the FDA involving bleeding problems among users of the medication, with 542 reports of death. By comparison, warfarin was linked to 1,106 adverse event reports, including 72 patient deaths.

As a result of the inability to stop bleeding that may develop, some have suggested that a Pradaxa recall should be issued, since the risks may outweigh the benefits provided over warfarin. However, there is no indication that U.S. regulators will remove the drug from the market, instead requiring stronger warnings about the risk of severe bleeding events.

Earlier this month, the FDA released an update to their ongoing investigation into the bleeding risk with Pradaxa, indicating that the rate of bleeds does not appear to be any higher than with warfarin. However, that finding has been criticized based on the methodology used and the failure to take into account the lack of an antidote to reverse bleeding that may occur while using the drug.

Boehringer Ingelheim currently faces more than 120 Pradaxa bleeding lawsuits filed in courts throughout the United States that allege the drug maker failed to adequately warn doctors and consumers about the risk of severe and uncontrollable bleeding.