FDA Fails to Stop the Bleeding With Pradaxa
- Ennis & Ennis News
11/08/2012 - Despite hundreds of deaths and a significant number of adverse-event reports, the FDA backed the controversial anti-coagulant drug, Pradaxa finding that the rates of gastrointestinal bleeding and intracranial hemorrhage were no higher in Pradaxa patients than in other patients using Coumadin (warfarin). However, the FDA clearly missed the obvious dangers of Pradaxa-no antidote. With warfarin, should a patient start bleeding uncontrollably, a doctor can administer Vitamin K to reverse the drug’s effects. With Pradaxa, no such failsafe exists and numerous patients have died when doctors couldn’t stop the bleeding.
The number of deaths from Pradaxa may be higher than originally thought because many of the Pradaxa deaths are caused by internal bleeds, which may not be immediately apparent to the patient. Often, once a patient realizes they have a serious medical condition it is often too late. Additionally, due to irreversible Pradaxa cerebral hemorrhages, patients have a one-in-four chance of surviving this type of brain bleed. In fact, the blockbuster drug resulted in more FDA reports of fatalities last year than any other drug. According to the The Philadelphia Inquirer’s health blog, Pradaxa led several categories including overall number of reports (3781), death (542), hemorrhage (2,367), acute renal failure (291), and stroke (644).
The risks associated with Pradaxa are widely known. The European Medicines Agency recently told manufacturer, Boehringer Ingelheim, to add stronger warnings to its labeling concerning possible bleeding side effects. Pradaxa is now the main competitor of Coumadin and hit the $1billion sales range, helping Boehringer Ingelheim report a big earnings increase. The FDA did note that healthcare professionals who prescribe Pradaxa should carefully follow the dosing recommendations in the drug label, especially for patients with renal impairment to reduce the risk of bleeding. However, many doctors fail to test their patients’ kidneys before prescribing the drug. Furthermore, a black box warning is clearly indicated due to the lack of treatment for uncontrolled bleeding risks.
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. |
