Pradaxa Internal Bleeding: Study Finds Warfarin May Be Safer

The preliminary data from a study examining Pradaxa and Warfarin has shown that a higher rate of complications is associated with Pradaxa internal bleeding. Pradaxa, generic name Dabigatran, has been linked to an estimated 459 deaths due to internal bleeding and other complications.

Pradaxa Side Effects Occur in Short-Term Treatment
The recent Pradaxa study “Dabigatran in the Real World” was conducted by anticoagulation expert and Chief Medical Officer of Standing Stone, Inc., Dr. Mark Wurster. The study was conducted on 2,200 patients taking oral anticoagulants. Those patients were followed while taking Warfarin for six months, then switched to Pradaxa and followed for another six months.

One of the patients on Warfarin was hospitalized with Warfarin toxicity, but no other dangerous side effects were reported. Among the Pradaxa side effects found were internal bleeding, treatment-related death, thrombosis, and other adverse events requiring the patient to discontinue Pradaxa use. Of 113 patients who produced evaluable data, one adverse Pradaxa side effect resulted in death due to gastrointestinal bleeding. Four others experienced bleeding episodes, including gastrointestinal bleeding and intracranial hemorrhage, and still others experienced deep vein thrombosis, atrial thrombus, and gastrointestinal side effects.

The preliminary results of the study were presented at the 2012 Thrombosis and Hemostasis Summit of North America. “This is the largest series to date that examines how dabigatran is being administered in real-world settings, and I think our findings illustrate some areas of concern with respect to new agents for anticoagulation therapy,” said Dr. Wurster.

Pradaxa Maker Ignores Lack of Pradaxa Antidote
Rather than address the Pradaxa internal bleeding risk, Pradaxa manufacturer Boehringer Ingelheim is focusing on understanding non-valvular atrial fibrillation, which is the condition Pradaxa treats. And Boehringer Ingelheim’s focus had helped boost its profits. In 2011, the company reported net sales of $17.4 billion, an increase of 6.2 percent from the previous year, which had reported net sales of $16.6 billion.

In 2011 alone, Pradaxa added to Boehringer Ingelheim’s net sales by $829 million. In a statement released by the company, a spokesman said “The launch of Pradaxa is among the most successful market introductions in the pharmaceutical industry in the past few years.”

One of the biggest criticisms of Pradaxa is that it does not have an antidote to stop internal bleeding like Warfarin does. With Warfarin, internal bleeding can be reversed with Vitamin K. But with Pradaxa, doctors have not yet found a viable antidote to reverse internal bleeding.

If you or a loved one experienced Pradaxa internal bleeding, you may be entitled to compensation for your injuries. Call experienced Dallas Pradaxa attorney Kay Van Wey today at (214) 329-1350 or (800) 489-5082 for a free consultation.