Pharmaceutical drug manufacturer Boehringer Ingelheim has asked European regulators to approve wider use of it anti-clotting drug Pradaxa. The company submitted an application to the European Medicines Agency (EMA) on Monday, requesting that the use of Pradaxa be extended to the treatment of acute deep vein thrombosis (DVT) as well as pulmonary embolism (PE), News Medical reports.
Pradaxa is an oral anticoagulant used to prevent or treat blood clots and reduce the risk of stroke, particularly in patients with atrial fibrillation. In the US, the drug has been linked to more than 500 deaths, yet remains on the market as a “safe” drug.
Despite this, Boehringer Ingelheim may now get approval for the expanded use of the drug in the European market. Reuters reports that rival pharmaceutical giant, Bayer, won approval for similar uses of its drug Xarelto, an oral anticoagulant that competes with Pradaxa, in November.
“Our studies have demonstrated that Pradaxa offers an effective treatment [for deep vein thrombosis or pulmonary embolism] with significant safety benefits compared to warfarin both for acute treatment as well as in the long-term prevention of recurrent events,” said Professor Klaus Dugi, Corporate Senior Vice President of Medicine for Boehringer Ingelheim.
Pradaxa was approved by the FDA in 2010 as an alternative to the existing anti-clotting drug warfarin (brand name Coumadin). However, unlike warfarin, there is no antidote to reverse Pradaxa’s blood-thinning effects. Boehringer Ingelheim claimed it was working on developing an antidote, but said that even without one, patients in their clinical trial died at roughly the same rate as those taking warfarin.
“Attorneys litigating the products liability action in the United States dispute the claim that Pradaxa is equally as safe as warfarin. We have some very serious concerns about the integrity and reliability of the data from Pradaxa’s clinical trials,” said attorney Ned McWilliams of Levin, Papantonio, who practices in the areas of product liability and bad drug litigation.
The German-based international pharmaceutical company has been cited for issues in the past. Last year the company was forced to pay $95 million to federal and state governments for illegally promoting some of its drugs for unapproved uses and dosages. The company also settled allegations that they had paid kickbacks to doctors and healthcare providers in order to promote and sell their products.
Alisha is a writer and researcher for Ring of Fire.