Safety concerns about the new anti-clotting drug, Pradaxa, have not abated, particularly as it has been linked to more than 500 deaths. When it was approved in October 2010, it was hailed as the first in a new category of replacements for Warfarin, the nearly 60-year-old drug used to prevent strokes in people with a heart-rhythm disorder known as atrial fibrillation.
But almost as soon as doctors started prescribing it, concerns surfaced about its safety. The drug was identified as the primary suspect in 542 patient deaths reported to the F.D.A. in 2011, and was linked to more reports of injury or death than any of the more than 800 drugs regularly monitored by the Institute for Safe Medication Practices, a nonprofit based in Pennsylvania that monitors medicine safety.
Experts are shocked Pradaxa was approved even though no antidote is available. Critics say at least until an antidote is found, better disclosure may be preferable.
Boehringer Ingelheim is expected to present several new studies of Pradaxa’s safety and efficacy – including potential antidotes – at the American Heart Association scientific conference in Los Angeles.