On February 5, 2014, an article was published in The New York Times investigating the controversy surrounding the blood-thinning medication Pradaxa (dabigatran etexilate mesylate). Recently, legal documents were publicized that included evidence that the manufacturer of Pradaxa may have attempted to cover up findings from a research paper that could potentially impact sales of the drug.
Pradaxa is an anticoagulant medication indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Manufactured by Boehringer Ingelheim, Pradaxa was FDA approved on October 19, 2010. Prescribing information for Pradaxa states that the drug, “…can cause serious and, sometimes, fatal bleeding.” Warfarin (brand name Coumadin) is an older anticoagulant with the benefit of having a reversal agent in cases where excessive bleeding occurs. No such antidote exists for Pradaxa.
There are currently thousands of lawsuits against Boehringer Ingelheim for failing to appropriately warn patients of the bleeding risk associated with administration of Pradaxa. There has been conflicting evidence presented regarding the safety of Pradaxa relative to warfarin, and the FDA announced in late 2013 that they will begin conducting an evaluation of stroke and bleeding outcomes in patients treated with these drugs. Sales of Pradaxa have yielded over $2 billion since its approval, though according to FDA Adverse Event Reporting System (FAERS) data, its use may be linked to over 2,500 deaths.
According to the New York Times, Chief Judge David Herndon released previously confidential Boehringer Ingelheim documents including memos, emails, and internal presentations that undermine the company’s previous claims that patients taking Pradaxa did not need routine blood tests to ensure the drug was working properly. This has been a major selling point for Pradaxa and newer anticoagulants such as Xarelto (rivaroxaban) and Eliquis (apixaban), as patients taking warfarin are required to obtain frequent blood work. Recent findings published in the Journal of the American College of Cardiology (co-authored by a Boehringer Ingelheim employee, Dr. Paul Reilly) demonstrated that patients could benefit from blood tests when taking Pradaxa as individuals metabolize the drug differently, and some patients may need much smaller or larger doses depending on how their bodies respond. Study authors concluded that, “Individual benefit–risk might be improved by tailoring dabigatran dose after considering selected patient characteristics.”
Before public release, this research article was circulated within Boehringer Ingelheim. Of the documents released by Judge Herndon were emails between company employees that voiced concerns over the potential negative effect the research results could pose to Pradaxa sales. According to the New York Times, conclusions of Dr. Reilly’s paper were altered to omit some of the offending findings. Investigations regarding Pradaxa lawsuits are ongoing.
Pradaxa (dabigatran etexilate mesylate) is a direct thrombin inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Manufactured by Boehringer Ingelheim, Pradaxa was FDA approved on October 19, 2010.
RxScore is a proprietary algorithmic scoring model based predominantly on post-marketed safety data from over five million FAERS reports. RxScore is presented on a 100-point scale meant to reflect both the breadth and seriousness of side effect(s) by incorporating nine differentially weighted categories including FAERS fields such as “Outcome,” “Event Seriousness,” “Report Type,” and “Event Reporter,” a disproportionality measure, and existing FDA warnings and DEA risk classifications. The score is also negatively adjusted by factoring in both “Condition Seriousness” and a patient’s existing comorbidities. A score of 100 indicates the highest potential adverse event risks.
Pradaxa has the 3rd highest RxScore out of the 20 drugs indicated for the treatment of atrial fibrillation. This signifies an above average level of risk compared to the other drugs in the same class.
To see the RxScores for all of the drugs indicated for the treatment of atrial fibrillation or to learn more about how RxScore supports comparative drug safety analysis, please login to AdverseEvents Explorer or contact firstname.lastname@example.org.
Using FAERS data (from 11/01/1997 to 12/31/2012), aggregated and standardized by the AdverseEvent RxFilter process, we identified 22,070 serious adverse events which listed Pradaxa as a suspect drug. Of these reports, 21,007 listed Pradaxa as the primary suspect.
The most commonly reported side effects were gastrointestinal hemorrhage (bleeding), hemorrhage (bleeding), and dyspepsia (indigestion). We identified 8,125 hospitalizations and 2,531 patient deaths where Pradaxa was indicated as the primary suspect.