Blood thinner, Pradaxa, is the leader in fatality reports to the U.S. Food & Drug Administration (FDA), according to a new report.
It seems, said FiercePharma, that Pradaxa, manufactured by Boehringer Ingelheim, was involved in more fatality reports to the FDA than any other drug last year. In fact, Pradaxa was the lead in reports in a number of categories: Overall reports, 3,781; deaths, 542; hemorrhage, 2,367; acute renal failure, 291; and stroke, 644, said FiercePharma, citing The Philadelphia Inquirer’s health blog that cited an Institute for Safe Medication Practices’ (ISMP) QuarterWatch program report. The report obtained data from the FDA MedWatch reporting system.
NewsInferno recently wrote that European regulators again asked Boehringer Ingelheim to update the Pradaxa to include additional information about bleeding side effects. The European Medicines Agency (EMA) said that the new guidance should include added information on when Pradaxa must not be taken and information concerning managing patients and reversing the anticoagulant effect, should Pradaxa bleeding occurs.
Approved in Europe in March 2008, Pradaxa was introduced for the prevention of venous thromboembolic events after hip or knee replacement surgery, NewsInferno explained. Pradaxa just had its European approval expanded to cover non-valvular atrial fibrillation for prevention of stroke and systemic embolism. Fatal Pradaxa bleeding events rose after the expansion, according to a Pharma Times report, said NewsInferno.
Pradaxa was the first of a new class of blood thinner medications called direct thrombin inhibitors, and is marketed as a safer alternative to Coumadin (warfarin), NewsInferno explained. Coumadin has some challenging issues including that it can cause dangerous interactions with other medications, that patients must avoid foods high in vitamin K (leafy greens, liver, green tea, cauliflower), and that patient blood must be monitored on a regular basis, noted NewsInferno.
While Pradaxa was touted as avoiding these issues, Pradaxa, Coumadin, and all blood thinners, can cause serious internal bleeding. The major issue is that, with Pradaxa, there are no antidotes to the bleeding, said NewsInferno. As a matter-of-fact, some recent Pradaxa bleeding fatalities have involved patients who died from serious internal bleeds after relatively minor traumas, such as falls involving head bumps. Similar drugs include Eliquis, from Bristol-Myers Squibb and Pfizer, and Xarelto from Johnson & Johnson, noted FiercePharma.
Last year, the FDA initiated a Pradaxa review over reports of bleeding-related side effects. Japanese regulators also directed Boehringer Ingelheim to strengthen Pradaxa warnings, said NewsInferno.
Meanwhile, in the face of mounting controversy and consumer lawsuits, Boehringer Ingelheim just issued a release stating that Pradaxa’s prescribing information has been updated to indicate that Pradaxa is superior to warfarin in reducing ischemic and hemorrhagic stroke, said FiercePharma.