Will The Bleeding Stop? Pradaxa Topped FDA Side Effect Reports

Will the bleeding stop? Last year, the FDA concluded that bleeding rates associated with Pradaxa, a relatively new bloodthinner, were no higher than among patients given warfarin, a decades-old medical standard. The assessment was designed to allay concerns that Pradaxa, which is used to reduce the risk of stroke and blood clots in patients with atrial fibrillation, but has been linked to hundreds of deaths. Meanwhile, a new analysis finds that Pradaxa, which was approved two years ago by the FDA, generated the largest number of adverse events reported directly to the agency during 2012. In all, there were 683 such reports concerning the Boehringer Ingelheim medicine, according to the Institute for Safe Medicine Practices, a non-profit that tracks drug safety and published the data in its latest QuarterWatch report (here it is). As a group, bloodthinners appear problematic. Following Pradaxa is warfarin, the decades-old standard of care, which prompted 492 direct reports. A third anticoagulant – Xarelto, which is marketed by Bayer (BAY) and Johnson & Johnson (JNJ) – ranked tenth in direct reports, and when both manufacturer and direct reports are included, the three drugs accounted for 6,234 cases of serious injury and 789 deaths. However, this was the second consecutive year in which Pradaxa led the pack and ISMP notes that the FDA analysis, which essentially, determined the benefits conveyed by the bloodthinner outweigh the risks, was lacking. The agency published i...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs