Pradaxa Recall Issued

A recall has been issued for one lot of the anticoagulant Pradaxa because problems with the bottles have the potential to affect the drug’s effectiveness.  The recall was issued last week by Boehringer Ingelheim for one manufacturing lot of 75mg Pradaxa pills.  A packaging defect may allow moisture into the bottles, which could diminish the efficacy of the pills.  Fortunately, these recalled pills have not been linked to any adverse events at this time.

This is not the first time consumers have been alerted to the damage moisture could cause to the medication.  The FDA issued a drug safety communication regarding Pradaxa in March 2011, cautioning users not to remove pills from blister packages or bottles too far before taking them could impact their effectiveness.  Even when kept in the original container, the drug must be used within 60 days or it could begin to break down and lose potency.

Pharmacists have been instructed to caution all patients given 75mg Pradaxa pills from the affected lot (NDC 0597-0149-54, lot 201900) and encourage them to return the pills in exchange for a free replacement.  The expiration date on the compromised pills is January 2014.

Pradaxa (dabigitran) is a blood thinner introduced in October 2010.  It is used to prevent strokes and heart attacks in patients with atrial fibrillation, and has been touted as a superior alternative to warfarin (Coumadin) because it requires less monitoring.  However, while both drugs may present an increased risk of internal hemorrhages, warfarin bleeds can be stopped with Vitamin K and there is no reversal agent for Pradaxa internal bleeding.

Within one year of Pradaxa’s release, the FDA received roughly 2,367 adverse event reports concerning the drug, with 542 deaths reported.  In contrast, 1,106 warfarin adverse event reports were received, with 72 patient deaths reported.

Some experts suggest that Pradaxa should be recalled, because the risk of potentially fatal internal bleeding outweighs benefits the drug provides over warfarin.  While stronger warnings have been mandated for Pradaxa labels, no recall is currently predicted.

Earlier in November, the FDA released information from an ongoing evaluation of Pradaxa bleeding risks, indicating that the rate of bleeds from Pradaxa is comparable to that from warfarin.  Still, some criticize the findings because researchers did not factor the lack of a reversal agent for Pradaxa bleeds into their analysis.


Contact a Pradaxa Lawyer

Hundreds of people who have suffered severe injury or the death of a loved one due to Pradaxa side effects have filed pharmaceutical product liability lawsuits against Boehringer Ingelheim, claiming that the drug maker did not provide sufficient warning about Pradaxa risks.  If you have been harmed by Pradaxa internal bleeding, you may be able to collect substantial compensation in a dangerous drug lawsuit.  Contact a personal injury lawyer to learn more about your rights in a free legal consultation.

Nov. 13, 2012 | Tags: Dangerous Drugs, Pradaxa

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