Pradaxa FDA Warning – Bleeding Complications & Legal Claims

Multiple FDA warnings have been issued against blood-thinner Pradaxa (dabigatran). Pradaxa is an anticoagulant medication, used to prevent the formation of blood clots, which works by inhibiting the clotting enzyme, thrombin. It was approved in 2010 and was designed to be a safer alternative to the 60-year old drug, Coumadin (warfarin), which requires frequent blood testing. By 2012, Pradaxa had already been linked to over 500 deaths from uncontrolled bleeding.

Approval of Pradaxa

Pradaxa was approved by the Food and Drug Administration (FDA) in October of 2010. The drug was touted as a revolutionary replacement for Coumadin (warfarin). Coumadin had been in use for nearly 60 years to prevent strokes for patients with atrial fibrillation and other conditions.

Pradaxa was said to offer an advantage over Coumadin as patients do not need to be monitored as closely for diet and drug interactions and are not required to undergo frequent laboratory testing.  Pradaxa’s efficacy and convenience helped it to become very successful and by 2012, sales had already reached the $1 billion mark for manufacturer, Boehringer Ingelheim.

Pradaxa Bleeding Complications

Despite its commercial success, shortly after Pradaxa’s approval, serious concerns began to emerge about the drug’s safety.  In 2011, the FDA received 3,781 reports of serious adverse events due to excessive bleeding in Pradaxa patients, including 542 deaths.  These events were complicated by the lack of an available antidote.

Other anticoagulants like Coumadin, work differently and can be treated with reversal agents.  At the time of Pradaxa’s approval, the company had determined that an antidote would not be necessary.  Recommendation for treatment of Pradaxa-associated hemorrhage included only hemodialysis to filter the drug from the patient’s bloodstream.  Patients who could not undergo hemodialysis were simply monitored until the drug had naturally cleared from the body.

FDA Safety Warning

In June of 2011, the first FDA notice was issued for Pradaxa.  A public alert notified healthcare professionals and the public about specific storage requirements, stating that Pradaxa should only be dispensed and stored in the original prescription container or blisterpak packaging.  The notice stated that improper storage or exposure to moisture could contribute to product breakdown and reduced efficacy.

Due to the number of serious adverse event reports, in December 2011, the Food and Drug Administration issued the first of several warning notices regarding the safety of Pradaxa.  The first warning only notified healthcare practitioners and the public that numerous bleeding events had occurred and were being evaluated by the agency. In November of 2012, the FDA issued an update to this warning, stating that recommendations regarding Pradaxa had not changed but indicating that a large study was underway to evaluate bleeding events.

In March of 2012, a report published in the Journal of the American College of Cardiology indicated that evaluation of 30,000 patients showed an increased risk of heart attack when compared to Coumadin.  No changes were made to labeling as a result of this study however in December 2012, a new and separate safety warning was issued stating that Pradaxa should not be used in patients with mechanical prosthetic (artificial) heart valves.  After a clinical study in Europe was halted, the FDA required that prescribing information include a contraindication against use in patients with artificial heart valves

In April of 2013, Pradaxa’s manufacturer Boehringer Ingelheim, announced that they were adding a “black box warning” to the prescribing information.  Information regarding an increased risk of clot formation and stroke when medication is suddenly discontinued was added to the top of prescribing information, enclosed in a black box.  This boxed statement warning was similar to that included on other anticoagulants.

In May of 2014, the FDA issued another alert which warned that though elderly Pradaxa patients had a lower risk of stroke, cerebral bleeding, and death than similar Coumadin patients, the risk of major gastrointestinal bleeding was increased.  The Medicare study used to provide this data also showed the two drugs had a similar heart attack risk. Again, no changes were required to be made to Pradaxa prescribing information.

Despite continuing reports of adverse events, Pradaxa was approved in November of 2015, to treat additional conditions including prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with hip replacements.

Pradaxa Antidote Approval

In October 2015, the FDA approved an antidote to Pradaxa through its fast-track “accelerated approval” pathway.  Praxbind (idarucizumab) works to reverse Pradaxa’s anticoagulant effects by binding to the drug and its metabolites.  It is given in emergency situations when bleeding cannot be controlled due to Pradaxa use. Though older medications like Coumadin already had antidotes, Pradaxa is the first of the “new” anticoagulants that can now be reversed.

Full approval for Praxbind was granted in April 2018, after final results from safety studies showed no unexpected results.  Most patients show complete reversal of blood thinning effect within 4 hours of Praxbind administration after emergency bleeding event.  Healthcare practitioners are advised to resume anticoagulant therapy when appropriate according to patient’s medical status.

Pradaxa Lawsuits

Thousands of patients have experienced serious complications including hemorrhage and death after using Pradaxa.  Over 4,000 Pradaxa lawsuits were settled in 2014 but some lawsuits remain in federal, state and local courts. If you or a loved one have experienced severe side effects while using Pradaxa, have your case evaluated by legal experts.