Posted On: May 6, 2012 by Patrick A. Malone

The Ugly Underbelly of the Blockbuster Drug Pradaxa

If you think the word “blockbuster” is reserved for popular entertainment like “Game of Thrones,” you probably don’t need to take a blood thinner. Such drugs are prescribed to people at risk of stroke from conditions such as atrial fibrillation (irregular, rapid heart rate).

In Pharma Land, the drug Pradaxa is considered a blockbuster, or a drug whose annual sales top $1 billion. It’s touted as superior to other anticoagulant drugs because it requires less monitoring.

But just as a blockbuster movie can be ravaged by critics, a blockbuster drug can collect seriously bad reviews.

Since its U.S. introduction in 2010 by Boehringer Ingelheim as an alternative to Coumadin (warfarin), Pradaxa has engendered hundreds of adverse event reports to the FDA, according to AboutLawsuits.com, concerning hemorrhages and internal bleeding. Lawsuits charging wrongful death have cited Institute for Safe Medication Practices (ISMP) records tallying scores of deaths from bleeding.

Other anticoagulants, such as Coumadin, also pose a risk of bleeding, but patients on warfarin can be given vitamin K as a fast-acting reversal agent to bleeding problems. Pradaxa lacks such an antidote to disaster.

Lawsuits also challenge the rigor with which Boehringer Ingelheim researched its drug and allege that the company promoted it as an alternative to the older, safer warfarin despite failing to warn about the lack of a reversal agent.

More incidents of uncontrollable bleeding with Pradaxa, according to the ISMP, were reported during the first quarter of 2011 than were reported for any other drug monitored by the institute. More than 500 reports were made about Pradaxa versus 176 for warfarin, which ranked second.

Researchers have suggested that Pradaxa drug trials were flawed, and the FDA is investigating the bleeding claims, as are agencies in Europe and Canada.

But if you’re Boehringer Ingleheim you don’t dare argue with success. The company recently boasted that the launch of Pradaxa was “among the most successful market introductions in the pharmaceutical industry in the past few years.”

Not if you’re a Pradaxa patient bleeding to death with no way to stop it.

Although the FDA still considers Pradaxa a worthy drug, it has recommended that Pradaxa patients immediately contact their doctor if they detect signs of bleeding problems. They are:


  • unusual bleeding from the gums;

  • frequent nose bleeds;

  • unusually heavy menstrual or vaginal bleeding;

  • severe, uncontrolled bleeding;

  • pink or brown urine;

  • red or black stool that looks like tar;

  • unexplained bruises that grow over time;

  • coughing up blood or blood clots; and/or

  • vomiting blood or a substance that looks like coffee grounds.

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