Pradaxa Bleeds Take the Lead with Adverse Events Reports filed with the FDA
- Ennis & Ennis News
10/25/2012 - Of all the new drugs on the market, anticoagulant, Pradaxa, received the highest volume of adverse events reports with the U.S. Food and Drug Administration (FDA) due to Pradaxa bleeds or hemorrhages, according to the Institute for Safe Medicine Practices (ISMP). Pradaxa was responsible for nearly six times more reported bleed events when compared to three major anticoagulants, Rivaroxaban, Warfarin and Enoxparin.
In fact, according to ISMP the number of prescription drug reports filed with the FDA has increased 90% since 2008 and two drugs, Pradaxa and Chantix, are responsible for 37% of that increase.
Pradaxa was FDA approved in October 2010 and quickly became one of the top ranked drugs for adverse event reports. ISMP and the Journal for The American Medical Association have reported that the FDA’s rapid launch of the drug may be responsible for the Pradaxa bleed oversight. In 2011 the FDA received almost 4,000 reports of side effects and 542 deaths among Pradaxa users.
On December 7, 2011, the U. S. Food and Drug Administration (FDA) issued a Safety Communication reporting that it was investigating reports of serious and fatal bleeds in patients taking Pradaxa.
In August 2012 an MDL was established wherein all Pradaxa lawsuits involving Pradaxa bleeds were consolidated to the U.S. District Court for the Southern District of Illinois before Judge David Herndon.
Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies, as well as medical device makers.
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Pradaxa Side Effects Lawyer Accepting Cases
If you or a loved one have suffered serious side effects of Pradaxa, Pradaxa injury or death while using Pradaxa you may be entitled to compensation. Contact the Pradaxa side effects lawyers of Ennis & Ennis, P.A. today for a free nationwide case evaluation. Our experienced Pradaxa attorneys can answer any questions you may have about Pradaxa litigation, Pradaxa side effects, a potential Pradaxa lawsuit or even a possible Pradaxa class action lawsuit. Fill out the Pradaxa lawsuit case evaluation form on this page or call toll free: 1.800.856.6405.