With reports of Pradaxa bleeding on the rise, regulators in Australia are now reconsidering their  recent recommendation that the blood thinner be used in that country.  According to a report from The Pharma Times, should the Pharmaceutical Benefits Advisory Committee (PBAC) rescind its recommendation, the cost of Pradaxa would no longer be covered under Australia’s government-sponsored  health insurance plan.

In March 2011, the PBAC recommended that Pradaxa be available on Australia’s Pharmaceutical Benefits Scheme for the prevention of stroke or embolism in certain groups of patients with atrial fibrillation.  The recommendation followed the Committee’s determination that it “represented a cost-effective therapy and its use could lead to reductions in morbidity,” The Pharma Times said.  But a new report from the PBAC Chairman released last week noted that use of Pradaxa in real-world settings has been different to the clinical trial evidence the Committee reviewed prior to making its 2011 recommendation.  The group now says the drug requires more study, and that “it is of a mind to rescind its March 2011 recommendation.” Boehringer Ingelheim, the manufacturer of the blood thinner, has been invited to submit new data to the committee.

Pradaxa Side Effects

Pradaxa is a direct thrombin inhibitor used to reduce the risk of stroke and embolism in patients with non-valvular atrial fibrillation.  It was approved by the U.S. Food & Drug Administration (FDA) in October 2010, and was intended to be a replacement for warfarin, a decades-old anticoagulant that requires patients to undergo frequent blood testing, and can interact dangerously with certain other drugs and foods.   Pradaxa can place patients at risk for serious internal bleeding, as can warfarin.  However, there exists no readily available antidote for Pradaxa bleeding, while hemorrhaging in warfarin patients can be stopped via the administration of vitamin K.

In December 2011, the FDA launched a safety review of Pradaxa due to concerns that the drug could cause dangerous, uncontrollable internal bleeding.  In 2011 alone, the agency had received reports of 542 deaths and 3,781 Pradaxa side-effect incidents.  The Institute of Safe Medication Practices has also reported that the medication has generated more reports of injury or death than any of the 800 drugs it monitors.

In November, the FDA issued an update stating that its review had not found evidence that Pradaxa posed a higher risk of bleeding compared to warfarin.  However, some critics complained that the agency’s review had failed to address the lack of an antidote for Pradaxa bleeding.

Just last week, the FDA issued yet another alert for Pradaxa, advising that it not be prescribed to patients with mechanical heart valves.  The alert followed the halt of the RE-ALIGN trial, which was ended because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users, the FDA said.  The drug’s  label is now being updated to reflect this new contraindication.

Pradaxa Lawsuits

Victims of alleged Pradaxa side effects have filed a number of lawsuits accusing Boehringer Ingelheim of marketing a dangerous drug.  At least 150 such claims are pending in a consolidated litigation in U.S. District Court, Southern District of Illinois (In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation – MDL No. 2385).  According to a recent report published by Bloomberg News, the blood thinner has generated more than $1 billion in sales since coming on the market.  Based on those numbers alone, some legal experts believe thousands of Pradaxa lawsuits could be filed in the coming months.

The attorneys at Bernstein Liebhard LLP are actively evaluating claims, and are offering free legal evaluations to victims of Pradaxa side effects.  To learn more about the legal options available to you, please give us a call today, at 1-877-779-1414.

Published December 26, 2012 by