Product News and Recalls

Real World Data Shows Stark Safety Contrast Between Xarelto and Pradaxa

real world numbers show xarelto dangers“A recent study indicated…” The phrase is used to introduce countless articles that report on the medical industry. This blog is no exception. Savvy consumers always have to be aware, however, of how those studies came to be. Who funded them? What was the exact question they sought to answer? What, if any, possible ulterior motives could exist for the creation of such a study? Information is there to be consumed but it must be consumed critically.

However, one type of data is very hard to manipulate, and that is real-world data sets. Real world numbers are effective because, at their most pure, there are limited ways to slice them. You take a population and you count the number of occurrences, or lack thereof, of a particular event within that population. The end result of the counting gives you your answer.

Such is the case with the latest look at the likelihood of bleeding events for patients taking two popular anticoagulants on the market. Boehringer Ingelheim’s Pradaxa and Johnson & Johnson/Bayer’s Xarelto have been slugging it out on the marketing stage for years. The marketing budgets for the drugs are rivaled by the GDPs of some countries. But a definitive leader may be emerging from a safety perspective according to a recent study.

In a study published in the Journal of the American Medical Association’s Internal Medicine edition, researchers looked at the records of 118,000 Medicare patients that took one of the two medications for atrial fibrillation. When compared to those taking Pradaxa, those on Xarelto showed a significantly higher likelihood of intracerebral hemorrhage and major extracranial bleeding; including major GI bleeds.

Independent real world studies like this are rare. Most drug manufacturers won’t pay for head-to-head studies that put their drugs up against those of their competitors. And sponsored real-world studies can be skewed.

Xarelto, however, continues to maintain its position as market leader despite a lengthy history of bleeding episodes – some of them fatal – and questions over the legitimacy of the very process that brought the product to market.

With billions of dollars on the line and ever-increasing stakes for stockholders, one can only expect the onslaught of data and marketing buys to continue. Consumers will have to be as critical as ever as they work to keep themselves and their families safe while sitting in the crossfire.