Blood-Thinner Report Contested by Manufacturers

In February, a report issued by AdverseEvents, a healthcare information organization, evaluated the risk of bleeding problems with Pradaxa, Xarelto, and Eliquis. It compiled its data based on adverse events reported to the FDA on all three drugs. The results of the report indicated that Eliquis, a relatively new anticoagulant medication, appears to be safer than Pradaxa and Xarelto. Eliquis is manufactured by Pfizer, while Pradaxa and Xarelto are manufactured by Boehringer Ingelheim and Johnson & Johnson with Bayer, respectively. Now, these three manufacturers are taking issue with the results of that report.

All three of these medications are blood-thinners, or anticoagulants. They are typically prescribed to treat atrial fibrillation, pulmonary embolism, deep vein thrombosis (DVT) and similar disorders. They work by reducing the blood’s ability to clot.

Older generations of oral anticoagulants such as Coumadin (warfarin), as well as antiplatelet agents like aspirin and clopidogrel (Plavix) have been available to consumers for decades and boast extensive safety studies. The new orally active anticoagulants (NOACs) such as apixaban (Eliquis), rivaroxaban (Xarelto), and dabigatran (Pradaxa) have been under fire in recent years for safety concerns, such as life-threatening bleeding problems due to Pradaxa.

Manufacturers cite faulty methodology

The AdverseEvents report analyzed the safety of these medications using multiple analysis methods, including RxFilter and the RxScore system, to sort through adverse events reported to the FDA. Despite these safeguards in place to ensure accuracy of the data, the manufacturers of Pradaxa and Xarelto are claiming that the information is unreliable and unscientific. They base their claims on the supposition that voluntary adverse event reports are a small percentage of the actual events experienced by patients.

The manufacturers also claim that the study is unfairly biased against their medications. This is likely because Eliquis is a relatively new anticoagulant drug and a mere 435,000 prescriptions have been written for it. In comparison, about eight million prescriptions have been written for Pradaxa since October 2010 and 5.4 million prescriptions have been written for Xarelto. The comparatively small number of prescriptions written for Eliquis and its recent introduction to the market may account for the smaller number of adverse events associated with it.

Significant bleeding problems with Pradaxa reported

Regardless of whether the AdverseEvents report is based on flawed or biased methodology, other independent organizations have verified the significant number of adverse events associated with Pradaxa. In fact, the Institute for Safe Medication Practices (ISMP), a highly regarded independent consumer advocacy organization, noted that out of all the drugs available to consumers in 2011, Pradaxa had the most number of adverse event reports. In 2013, the ISMP warned that bleeding problems with Pradaxa can be up to five times more likely to take the life of a patient, as compared to bleeding events that occur with warfarin.

The severe complications associated with Pradaxa have prompted over 2,000 lawsuits from patients and their families, who claim that they were never properly warned of the risk of life-threatening bleeding. In particular, these Pradaxa lawsuits make note of the lack of a reversal agent for the drug, which could have saved hundreds of lives.