Pradaxa leads FDA MedWatch list of fatalities

Boehringer Ingelheim's blockbuster anticoagulant Pradaxa resulted in more reports to the FDA of fatalities of than any other drug last year.

In fact, Pradaxa lead all other monitored drugs in several categories, including overall number of reports (3,781), deaths (542), hemorrhage (2,367), acute renal failure (291) and stroke (644), according to The Philadelphia Inquirer's health blog. The Inquirer cites a report from the Institute for Safe Medication Practices' QuarterWatch program, which gets its data from the FDA MedWatch reporting system.

The risks of Pradaxa are widely known. In fact, just recently, the European Medicines Agency told the company to add stronger warnings about possible bleeding side effects to its labeling in Europe. The drug is one of a new generation of rivals to warfarin, known by brand name Coumadin, which dominated the market for 50 years but with a long list of shortcomings. Pradaxa this year hit the $1 billion sales range and helped the company report a big earnings increase.

But Pradaxa and its peers--Eliquis, from Bristol-Myers Squibb ($BMY) and Pfizer ($PFE), and Xarelto from Johnson & Johnson ($JNJ)--have a significant drawback. While warfarin has an antidote--vitamin K--that can reverse its effects, Pradaxa and its new class of rivals do not. That fact has led to a number of cases of fatal bleeding, and some of those have lead to lawsuits from families of patients who claim that the risks were not spelled out,

The QuarterWatch report comes out even as Boehringer Ingelheim today put out a release saying that prescribing information has been updated to say that Pradaxa is better than warfarin in reducing ischemic and hemorrhagic strokes. The Inquirer points out that there is nothing scientific about the QuarterWatch report. They are simply the ones most reported on by consumers and medical professionals. 

- read the Philadelphia Inquirer piece
- here's the QuarterWatch report
- get the Pradaxa release