Despite Bleed Problems, Pradaxa Sales Soar

Boehringer Ingleheim’s relatively new anticoagulant Pradaxa has hit blockbuster status, even amid hundreds of deaths and other serious injuries caused by bleeding problems experienced by users of the medication. 

Blockbuster status is a title reserved in the pharmaceutical business industry for medications whose annual sales top $1 billion.

According to a statement issued this week by Boehringer Ingleheim, Pradaxa sales reached $831 million in 2011. However, for the 12 month period ending in February 2012, sales of the drug passed the $1 billion mark.

Pradaxa (dabigitran) was introduced in the United States in October 2010, and was the frontrunner of a new breed of anticoagulants known as direct thrombin inhibitors, which also now includes Bayer and Johnson & Johnson’s Xarelto, and Eliquis, a Pfizer and Bristol-Myers Squibb drug.

The drug maker has aggressively marketed Pradaxa to physicians and directly to consumers as a replacement for warfarin, an older anticoagulant. Pradaxa has been promoted as superior because it requires less monitoring.

However, within months of the drug’s introduction, concerns emerged about the risk of bleeding problems with Pradaxa, with hundreds of complaints filed with the FDA’s adverse event reporting system (AERS).

According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of bleeding problems with Pradaxa were reported to the FDA during the first quarter of 2011 than were reported in association with any other drug monitored by the group.  At least 505 instances involving Pradaxa bleeding events were reported, compared to 176 cases reported with warfarin, which was second on the list.

While Pradaxa requires less monitoring than warfarin, the medication lacks a quick “antidote” to counteract bleeding problems when they do occur. With warfarin, doctors are able to stop the bleeding with the use of a reversal agent, like a dose of vitamin K. There is no quick fix for Pradaxa.

Pradaxa safety investigations are now underway in the U.S. by the FDA, as well as in the European Union and Canada.

Despite the concerns surrounding the bleeding problems, Boehringer Ingleheim is boasting that the launch of Pradaxa was “among the most successful market introductions in the pharmaceutical industry in the past few years.”

However, the drug maker now faces a growing number of Pradaxa lawsuits brought on behalf of individuals who have suffered serious bleeding problems or death. The complaints allege that Boehringer Ingleheim introduced the medication without adequate warnings about the Pradaxa bleeding risk or the lack of a reversal agent.