Pradaxa Sales Continue to Balloon While Adverse Events Pile Up

The anticoagulant drug Pradaxa (dabigatran) saw its sales continue to climb as adverse bleeding events continue to pile up. According to Cardiovascular Business, the manufacturer has reported that its now-blockbuster drug saw a robust 6.2 percent increase in net sales for the fiscal year 2011. Concurrently though, over 3,000 reports of adverse events were collected by the FDA in the last three months of 2011, with hundreds of deaths making it the most deadly prescription drug in the last quarter of the year, according to reports. Pradaxa (dabigatran) is an oral blood thinner in class of drugs called direct thrombin inhibitors, prescribed to prevent strokes among patients with non-valvular atrial fibrillation (a kind of irregular heartbeat).

A lack of an antidote poses a considerable risk for many patients.

Despite its new labeling as a blockbuster drug (over $1 billion in annual sales), Pradaxa concerns continue to mount as adverse side effects flow into the U.S. Food and Drug Administration (FDA). Some serious adverse events linked with Pradaxa are brain hemorrhaging, gastrointestinal (GI) bleeding, kidney bleeding, and other significant bleeding events which occur after even minor trauma. Recently, three doctors at the University of Utah reported in the Journal of Neurosurgery that an 83-year-old man was admitted after a routine fall in his home, but experienced extensive brain hemorrhaging that could not be stopped due to the presence of the drug in his blood.

Pradaxa was the first anticoagulant approved by the FDA in over 50 years, and it has been seen by many as a replacement for Warfarin. Like Warfarin, doctors and researchers believe that the problem with Pradaxa is that it is impossible to stop bleeding complications in patients because there is no known effective reversal agent to counteract the blood-thinner. This lack of an antidote poses a considerable risk for many patients, especially the fall-prone elderly. Pradaxa is manufactured by Boehringer Ingelheim Pharmaceuticals Inc., which is based in Germany. In December, the FDA agreed to review mounting post-market reports of bleeding complications, but have yet to release any new warnings on the drug.

The FDA is still reviewing the possible bleeding risks of Pradaxa, but there may be significant potentially-fatal adverse events that are made worse by the popular blood thinner prescription drug. If you or a loved one has suffered a bleeding complication while taking Pradaxa, you have legal recourse. Contact an experienced Pradaxa attorney by completing the form on the right to see if you may be eligible to see compensation for medical bills, lost wages, and pain and suffering.