August 15, 2009 – Boehringer Ingelheim researchers submitted Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial data to The New England Journal of Medicine
October 19, 2010 – Pradaxa approved by FDA to prevent stroke in patients with atrial fibrillation.
December 2011 – FDA announced an investigation into a significant number of reports linking episodes of serious, uncontrollable bleeding with Pradaxa use.
November 2012 – FDA released another opinion on the safety of Pradaxa following an FDA evaluation of Pradaxa bleeding events recorded via the FDA’s Sentinel Initiative Mini-Sentinel pilot program. Though the FDA did not find the Pradaxa bleeding risk to be significantly higher than the warfarin bleeding risk, the regulatory body stated that it is continuing its efforts into investigating Pradaxa’s health risks.
December 2012 – Food and Drug Administration (FDA) supplied a safety update on Pradaxa regarding to patients with mechanical heart valves. The FDA recommended that Pradaxa not be prescribed to patients with mechanical prosthetic heart valves due to the high occurrence of blood clots, heart attack, or stroke.
Following Pradaxa’s FDA approval, there have been ever increasing adverse event reports submitted to the FDA citing severe bleeding risks and death all linked to Pradaxa. If you or someone you love has been injured by Pradaxa, contact a Carey Danis & Lowe Pradaxa lawyer.
Our Pradaxa lawyers are providing free legal consultations of Pradaxa cases, and can provide assistance in filing a Pradaxa lawsuit. Contact a Pradaxa lawyer today by calling 800.721.2519 or by submitting a legal claim form.References: Pharmaceutical litigation, Pradaxa