You’ve probably seen commercials for the new blood thinning drug Pradaxa. But you may not have heard of the latest controversy swirling around. It turns out that Pradaxa is the most recent example of what can happen when a drug that performs well in tightly controlled trials is released into the messy world of real-life medicine.
Pradaxa was identified as the “primary suspect” in 542 deaths reported to the FDA in 2011. It was also linked to more reports of injury or death than any of the more than 800 other drugs regularly monitored by the non-profit organization the Institute for Safe Medication Practices.
Despite these reports, the FDA insists that Pradaxa poses no more risk than the older blood thinning drug Warfarin. But they never stopped to consider that there is no antidote when something goes wrong.
With substances that are essentially metabolic poisons—like blood thinners—it is critical to have antidotes available. They are the only means of managing side effects like bleeding.
Warfarin (Coumadin) has been used as a blood thinner for decades. And make no mistake, thinning the blood is a very dangerous proposition that can lead to internal bleeding and external hemorrhaging, sometimes fatal. In fact, warfarin is used in rat poisons because it causes pests to bleed to death. But the important difference is that there is a ready antidote to warfarin…The common nutrient vitamin K.
This story proves my point, once again, that when it comes to pharmaceutical drugs, newer is not always better—or safer.