The product liability lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for individuals who have experienced severe and uncontrollable bleeding problems from side effects of Pradaxa.
Pradaxa is a new-generation oral anticoagulant that has been linked to thousands of reports involving:
- Internal Bleeding or Gastrointestinal Bleeding
- Brain Hemorrhage
- Kidney Bleeding
Although drug maker agreed to pay more than $650 million in Pradaxa lawsuit settlements, our law firm is continuing to review potential cases, as inadequate warnings continue to be provided for consumers and the medical community.
Potential Xarelto lawsuits are also being reviewed for bleeding injuries associated with this similar anticoagulant.
To review whether you or a loved one may be entitled to financial compensation, request a free consultation and case evaluation.
PRADAXA PROBLEMS WITH INTERNAL BLEEDING, HEMORRHAGES
Pradaxa (dabigatran) was introduced by Boehringer Ingelheim on October 19, 2010 as a revolutionary blood thinner prescribed for prevention of strokes among patients suffering from atrial fibrillation. However, the medication has also been widely used off-label for other purposes.
While all blood thinners carry a risk of gastrointestinal bleeding, reports suggested that Pradaxa carries a greater risk than was indicated on the warning label.
During the first three months the blood thinner was on the market in the U.S., the FDA received 307 reports of Pradaxa problems involving internal bleeding and other complications, particularly among elderly users.
More than 260 Pradaxa deaths from internal bleeding were reported during the first year the drug was on the market, and the number of severe complications associated with Pradaxa continue to rise.
According to a report by the Institute for Safe Medication Practices, which analyzed adverse event reports submitted to the FDA between October 2010 and December 2010, more problems with Pradaxa were reported than were associated 98.7% of the other drugs the organization monitors.
ALLEGATIONS RAISED IN PRADAXA LAWSUITS
Many critics have questioned the clinical trials used to gain FDA approval and some have suggested that a Pradaxa recall should be considered to protect consumers.
Pradaxa was approved based on a clinical study known as RE-LY, which compared the novel oral anticoagulant with warfarin, a blood thinner that has been on the market for decades. However, experts have indicated the study was fundamentally flawed, allowing bias and errors to creep into the results.
Lawsuits over Pradaxa allege that inadequate warnings were provided about the bleeding risks associated with the medication and the lack of an effective reversal agent. While doctors are able to quickly reverse the blood thinning effects of warfarin, Pradaxa was introduced without a safe and effective antidote.
This has caused thousands of individuals to suffer uncontrollable bleeds or hemorrhages on Pradaxa, often resulting in death or debilitating complications.
Pradaxa injury lawsuits also raise claims that the drug’s manufacturer provided false and misleading claims to physicians by indicating that no blood monitoring is needed.
While the drug maker has marketed Pradaxa as superior to warfarin because it does not require frequent blood monitoring, independent research suggests that many Pradaxa bleeding events may have been avoided if some blood monitoring had been recommended.
Individuals throughout the United States who experienced problems may be eligible to pursue a Pradaxa lawsuit as a result of Boehringer Ingelheim’s failure to adequately research their medication or warn about the risk of serious and potentially life-threatening side effects.
PRADAXA CLASS ACTION LAWYERS
Potential Pradaxa class action lawsuits and individual injury lawsuits are being reviewed for individuals throughout the United States who have been hospitalized or died as a result of uncontrollable bleeding.
The Pradaxa injury lawyers at Saiontz & Kirk, P.A. handle all cases under a contingency fee agreement, which means that there are no out-of-pocket expenses to hire our law firm and we receive no attorney fees until a recovery is obtained for a Pradaxa injury.