Despite all the company assurances that the anticoagulant Pradaxa is a superior alternative to warfarin, the Food and Drug Administration (FDA) plans to once again compare the two. Pradaxa was approved in 2010 but has since then brought a high complication rate to its users  – including dangerous and uncontrolled bleeding for which there is no antidote.

Pradaxa (dabigatran) is prescribed to patients with nonvalvular atrial fibrillation. Made by the German company Boehringer Ingelheim, the FDA will look at the bleeding risks for the drug through its Mini-Sentinel Program, which uses healthcare data, such as insurance claims, to assess the risks of FDA-approved drugs. Potentially upward of 100 million patients could end up participating through their anonymous data.

mini-sentinel

Because warfarin is ranked No. 2 by the FDA for adverse events, newly developed anticoagulants have found willing and receptive users. Competitors, including Xarelto and Eliquis, would like to get in on the action. Unfortunately, all three of the newer anticoagulants do not have an antidote to stop uncontrolled bleeding. The companies say they are working on one. The other two companies are not under a re-review by the FDA.

Boehringer is expected to generate $1 billion in sales in 2014 and anticoagulants are the fastest growing area for drug sales.

The FDA has posted a request for public comment, reports Forbes. Specifically the agency is looking to “assess systematically the rates of bleeding and the thromboembolic outcomes associated with the use of dabigatran and warfarin for patients with atrial fibrillation using data from the FDA Mini-Sentinel Distributed Database (MSDD).”

The goal is to identify which users are at a higher risk for major bleeding and which are not. Boehringer reminds the public that just because the FDA is requesting data does not mean there is any problem with the safety of the drug.

Two previous Mini-Sentinel reports, one issued in November 2012 and the other in April 2013 comparing warfarin to Pradaxa, found the bleeding rates to be roughly comparable.

Despite that, the Institute for Safe Medication Practices found that in 2012 Pradaxa topped the list of adverse event reports to the FDA and represented that the risk of fatal bleeding may be five times higher among Pradaxa users. At the same time more than 580 patients suffered fatal outcomes linked to Pradaxa.

The adverse event reports keep coming in, so much so that multidistrict litigation has consolidated about 2,100 cases in the Southern District of Illinois (MDL No. 2385) among patients who experienced life-threatening and uncontrolled bleeding and internal hemorrhage.