New Study Shows Anticoagulant Medication Not as Safe in Real World
Attorneys First to File Pradaxa® Lawsuits Not Surprised by Preliminary Results Comparing the New Drug to Warfarin
Houston, TX (Law Firm Newswire) May 16, 2012 - Preliminary results from a large study comparing the new anticoagulant medication dabigatran (Pradaxa®) to warfarin (Coumadin®), a drug widely used since 1954, confirms safety concerns. Attorneys with Watts Guerra Craft, the first law firm to file Pradaxa lawsuits in the U.S., say the findings are not surprising.
“This study in real-world settings is proving what we already believed to be true,” says attorney Ryan L. Thompson. “The new medication is not safe and should be recalled immediately.”
The FDA approved Pradaxa, a direct thrombin inhibitor anticoagulant, in October 2010 as an alternative to warfarin for the prevention of complications including stroke and systemic embolism in patients with non-valvular atrial fibrillation, the most common type of abnormal heart rhythm. Reports of serious and deadly side effects followed.
In November 2011 manufacturer Boehringer Ingelheim confirmed at least 260 fatal bleeding events in patients taking Pradaxa. The FDA is now investigating post-marketing reports.
In preliminary results of the active study, “Dabigatran in the Real World,” we learn that one patient taking warfarin developed toxicity requiring hospitalization. In patients taking Pradaxa, the results appeared much worse. One patient died from gastrointestinal (GI) bleeding and two others suffered GI bleeding. Other bleeding events included one with one rectus sheath hemorrhage and one with intracranial hemorrhage, or bleeding in the brain. One patient developed deep vein thrombosis, one atrial thrombus, and one a transient ischemic attack. Four patients showed GI symptoms, ending their Pradaxa usage, and another developed a skin rash.
“Anyone who took this new drug and suffered serious side effects should speak to an experienced Pradaxa attorney immediately,” says Thompson. “Don’t wait until applicable time limitations pass.”
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