According to the preliminary results of an ongoing study, Boehringer Ingelheim’s new blood-thinning drug Pradaxa (dabigatran etexilate) may be substantially more dangerous than Coumadin (warfarin), the medication it was designed to replace. To date, the U.S. Food & Drug Administration (FDA) has received numerous reports of deaths and other complications from uncontrollable bleeding linked to Pradaxa.
Free Pradaxa Lawsuit Evaluation: If you or a loved one has been injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the problem?
May 8, 2012 – At last week’s Thrombosis and Hemostasis Summit of North America (THSNA), researchers from Alere, Inc. discussed the interim findings from an ongoing study designed to analyze the safety and efficacy of new anticoagulant medications. They found that patients being treated with Pradaxa have to be taken off the drug due to serious side effects more often than patients taking Coumadin, with the majority of the Pradaxa complications occurring early on in the course of treatment.
Coumadin is an older anticoagulant used to reduce the risk of strokes and blood clots in high-risk patients. Over the past several years, there have been increasing efforts to synthesize alternative blood thinning drugs, as coumadin requires extensive patient monitoring. Although Pradaxa has been marketed by Boehringer Ingelheim as superior to Coumadin because it requires less monitoring, hundreds of adverse events have been reported to the FDA linking the drug to severe bleeding and other serious complications.
The Alere study investigated 2,200 patients being treated with oral blood thinning drugs, and found that the rate of complications associated with Coumadin was 0.88%, compared to 11.5% with Pradaxa. During the research, just one patient being treated with Coumadin was hospitalized due to drug toxicity. By comparison, Pradaxa complications included:
- one death from gastrointestinal bleeding;
- four other severe internal bleeding events;
- one case of deep vein thrombosis (DVT);
- a heart attack;
- one atrial thrombus;
- one skin rash;
- four cases of gastrointestinal problems so severe that the patients had to be taken off the drug.
According to a report published earlier this year by the Institute for Safe Medication Practices, more internal bleeding complications were reported in connection with Pradaxa during the first quarter of 2011 than with any other drug monitored by the group. During that short period, at least 505 bleeding events involving Pradaxa were submitted to the FDA’s Adverse Event Reporting System (AERS), compared to just 176 cases associated with Coumadin, which was second on the list.
As the controversy surrounding Pradaxa’s internal bleeding side effects has grown in recent months, so too has the number of lawsuits filed over the drug increased dramatically. The vast majority of these complaints allege that Boehringer was negligent in failing to adequately research their drug, or warn about the risk of serious and potentially life-threatening internal bleeding events associated with Pradaxa use.
Do I Have a Pradaxa Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Pradaxa lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.