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The makers of Pradaxa and Xarelto are pushing back against a new report that claims Pfizer’s Eliquis may be the safest of the new breed of anticoagulants, which have been linked to reports of uncontrollable bleeding.
Last month, the healthcare information company AdverseEvents published a report (PDF) that examined the comparative safety of blood thinners such as Pradaxa, Xarelto, and Eliquis.
According to the findings of the study, Eliquis appeared to be the safest of a class of drugs, known as direct factor Xa inhibitors. Other types of blood thinners were examined as well.
The findings were based on an analysis of adverse event reports submitted to the FDA. However, the manufacturers of Pradaxa and Xarelto say the report is unfair to their products and that analysis of FDA adverse event reports is unscientific and unreliable given the randomness of the voluntary reports, which many experts say only represent a fraction of the actual incidents linked to a particular product.
Pradaxa is manufactured and distributed by Boehringer Ingelheim, and Xarelto by Johnson & Johnson and Bayer. Both drugs have been approved by the FDA for multiple uses and are prescribed to far more patients; Pradaxa has had 8 million U.S. prescriptions since its approval in October 2010, and Xarelto has been prescribed 5.4 million times.
Eliquis is approved for only a single use and has only a small share of the new blood thinner market, with just 435,000 prescriptions. Its competitors point out that this means there are far, far fewer people to report problems compared to Pardaxa and Xarelto.
According to the Institute for Safe Medication Practices (ISMP), Pradaxa had the most adverse event reports of any drug in 2011 and in 2012 the number of reports submitted continue to be alarmingly high. A 2013 ISMP report suggested that bleeding problems with Pradaxa may be five times more likely to result in death for a patient when compared to those associated with the use of warfarin, highlighting the impact of the lack of a reversal agent.
All three drugs are designed to prevent stroke in patients with atrial fibrillation and were meant to replace warfarin, also sold under the brand name Coumadin.
All blood thinners are linked to an increased risk of bleeding events, which can be life-threatening if uncontrolled. However, warfarin has an antidote, vitamin K, which can quickly counteract its anticoagulant effects. There are no approved reversal agents for the newer drugs.
Xarelto and Pradaxa Lawsuits
Boehringer Ingelheim currently faces more than 2,000 Pradaxa lawsuits filed by individuals who say the company failed to warn the medical community that there was no reversal agent.
Since August 2012, the federal Pradaxa litigation has been consolidated as part of an MDL, which is centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts. The company also faces Pradaxa lawsuits in state courts in Illinois, California and Connecticut.
As part of the coordinated management of the cases in the federal court system, Judge Herndon has scheduled a series of early trial dates in the Pradaxa MDL, known as bellwether cases. These trials are set to begin between August 2014 and February 2015, with the outcomes designed to help the parties gauge how juries are likely respond to certain evidence and testimony that may be repeated throughout a large number of cases.
Last month, what is believed to be the first Xarelto lawsuit brought against Johnson & Johnson and Bayer was filed in the Philadelphia County Court of Common Pleas, raising similar allegations.