Pradaxa Manufacturers Worried by Internal Study
Posted on Thursday, February 6th, 2014 at 2:53 pm by Williams Hart | Updated: Tuesday, September 25th, 2018 at 9:28 pm
Atrial fibrillation is a common disorder among people with irregular heartbeats. Patients who suffer from atrial fibrillation run a high risk of experiencing stroke, heart attack, and pulmonary embolism. In order to prevent the occurrence of these medical emergencies, physicians often prescribe an anticoagulant, like Pradaxa, to prevent dangerous blood clotting.
However, since its market release in 2010, Pradaxa has been linked to nearly 1,000 deaths related to excessive bleeding. Physicians are especially concerned about Pradaxa’s bleeding risks because, unlike older anticoagulants like warfarin, Pradaxa doesn’t have an antidote to counteract its blood thinning properties in emergency situations.
Though Pradaxa has caused excessive bleeding in some people, it has proved ineffective as an anticoagulant in other patients. Researchers cite individual patients’ metabolisms to explain the disparity in the drug’s efficacy. In fact, a recent article in the New York Times revealed that the manufacturers of Pradaxa, Boehringer Ingelheim, were worried about an internal research study’s results that indicated that Pradaxa users could benefit from regular blood testing to see whether or not the drug was working. One of the drug’s more marketable qualities was that it didn’t require regular blood testing, which older anticoagulants required, to prove efficacy. Recently unsealed legal documents have indicated that not only did some people within Boehringer Ingelheim pressure the researcher who published this study to revise some of its findings, but others suggested the study be “quashed altogether.”
In the few years that Pradaxa has been available to patients, it has sold more that $2 billion worth of the anticoagulant.
The attorneys of Williams Hart are investigating the claims of individuals who have been affected negatively by Pradaxa. If you or someone you know has been injured by this drug, call our offices at (713) 352-7071 to speak with a member of our legal team.