Pradaxa and Xarelto Problems 2016 Highest Priority Drug Safety Problem

According to the Institute for Safe Medication Practices’ QuarterWatch, an organization that monitors drug safety trends new oral anticoagulants (NOAC drugs), Pradaxa, Eliquis and Xarelto problems have earned them the title of 2016’s highest priority drug safety problem.

These NOAC drugs cause bleeding injuries in 8% to 19% of patients treated.

And, with more than 3.8 million patients prescribed one of these oral anticoagulants this is a problem that will affect more than 300,000 patients per year.

Prior to FDA approval of the newer anticoagulants (NOAC drugs), warfarin had been a standard for preventing unwanted blood clots since 1954.

But the use of warfarin was tricky in that it required bi-weekly monitoring, had quite a few interactions with food and other drugs and required individual dose adjustments generally at a doctors office.

This lack of convenience made for a great marketing campaign for Big Pharma to introduce their new drugs – Pradaxa, Xarelto, and Eliquis.

Big pharma spent hundreds of millions of dollars on advertising these drugs as both superior and more convenient.

Eliquis was the third most advertised drug in 2015, with Bristol-Myers Squibb spending $249 million on advertising just for Eliquis.

The campaign to move to NOAC drugs worked – they now capture more than 40% of the anticoagulant market.

But, seven years after approval of the new oral anticoagulants, it does not appear that the NOAC drugs are living up to either of these hyped benefits.

Several studies have shown that NOAC drugs are clinically equivalent to warfarin and several of the NOAC drugs continue to have major uncontrollable bleeding problems because there is no existing antidote.

Uncontrollable bleeds often lead to hospitalization, further injury and sometimes death.

According to the Institute for Safe Medication Practices, a nonprofit organization educating the healthcare community and consumers about safe medicine, Over the 10-year history of a Center for Disease Control adverse event study, emergency department visits for anticoagulant adverse drug effects increased more than 2-fold.

In fact, studies find that 6.3% of patients exposed to an NOAC drug for 12 months will need to visit the emergency department, with over 3% requiring hospitalization.

The CDC estimates 228,600 individuals will visit the emergency department annually due to anticoagulants.