Pradaxa Recall – Manufacturing & Packaging Defects

In November 2012, a single lot of Pradaxa (dabigatran) was recalled by Boehringer Ingelheim. This recall was not related to dangerous complications such as bleeding, that the drug may cause but was due to a manufacturing defect. Though the FDA has issued a number of warnings regarding Pradaxa, it remains on the market.

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Pradaxa is a prescription blood thinner used to prevent blood clot formation in patients with:

  • Atrial fibrillation (AF)
  • Deep vein thrombosis (DVT)
  • Pulmonary embolism (PE)

Pradaxa works by inhibiting thrombin, a clotting factor.  Unlike older anticoagulants, prior to 2015, there was no antidote for Pradaxa.  Its use has been associated with thousands of serious bleeding episodes and over 500 deaths.

Pradaxa Approval

Pradaxa was first approved by the FDA in 2010 to reduce the risk of stroke in patients with non-vascular atrial fibrillation (NVAF).  In 2015, use was expanded to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), to prevent recurrence of DVT or PE and to prevent DVT/PE in patients who undergo hip replacement surgery.  It is not approved to prevent blood clots caused by heart valve disorders or for use in patients with mechanical heart valves.

It was intended to compete with the popular blood thinner, Coumadin (warfarin) which had been in use for decades.  Within 2 years of its launch, Pradaxa was prescribed more than 3.7 million times in the U.S. Its success was largely due to its promotion as a safer and more convenient alternative, which unlike Coumadin, did not require frequent blood testing.

While the drug has helped millions, it can also cause fatal side effects. Because Pradaxa works differently, by inhibiting thrombin, its blood thinner action was not reversible by the administration of standard antidotes.  By 2012, thousands of severe bleeding events, including over 500 deaths were associated with Pradaxa treatment. Additionally, hundreds of lawsuits were filed against Pradaxa’s manufacturer, Boehringer Ingelheim.

A Pradaxa-specific antidote was not approved until 2015, when Boehringer-Ingelheim received expedited approval for Praxbind.  By that time however, many patients had already been harmed and consumer groups had advocated for its recall.

Single-Lot Pradaxa Recall

Unrelated to the possibility of serious adverse events, in November 2012, Boehringer Ingelheim voluntarily recalled a single lot of Pradaxa for manufacturing defects. According to Boehringer Ingelheim, the potential packaging defect posed a risk of compromising the integrity of the bottle, potentially exposing the drug to moisture.

Boehringer Ingelheim stated in a press release that moisture damage could pose a potential risk to patients.  Exposure to moisture may reduce the efficacy of Pradaxa and patients may not receive the full effect of a medication dose.  Pradaxa labeling states that the medication should only be dispensed in original blister-packs or manufacture’s packaging and should not be transferred to other containers.

Arguments for Pradaxa Recall

Prior to approval of reversal agent, Praxbind, consumer advocates and medical professionals had called for a Pradaxa recall.  As it works differently, standard antidotes used for Coumadin or heparin were ineffective in bleeding caused by Pradaxa.

The Journal for the American Medical Association (JAMA) prompted new discussion in favor of a Pradaxa recall in 2012. JAMA warned that FDA approval of Pradaxa may have been rushed due to the fact that severe side effects like uncontrollable bleeding were overlooked. Additionally, the Journal of Neurosurgery published a discussion on the concerns of bleeding episodes caused by Pradaxa.

Boehringer-Ingelheim had initially stated that a reversal agent was not necessary but after thousands of patients were harmed, Pradaxa was the subject of multiple lawsuits.  In 2015, Boehringer-Ingelheim received approval for a Pradaxa-specific antidote. Praxbind (idaracizumab) was approved in 2015 under the FDA’s expedited approval process. It received full approval in 2018 as a reversal agent for dabigatran in the event of life-threatening or uncontrolled bleeding or as needed for emergency surgery.

Despite the availability of Praxbind, some Pradaxa patients may still be at risk for hemorrhage or other side effects.

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