New Pradaxa Marketing Approvals Sought as Questions Remain

The drug manufacturer Boehringer Ingelheim has announced it is filing for new marketing approvals for Pradaxa, AP News has reported. The company announcement, released Wednesday, revealed that the FDA has received a marketing application for the controversial anti-coagulant. The application seeks approval to market the drug as a treatment for deep vein thrombosis (DVT) and pulmonary embolism. As part of the application, Boehringer Ingelheim noted that there are 900,000 DVT and pulmonary embolism cases every year in the U.S., a third of which lead to death. DVT occurs when blood clots in a deep vein, most commonly in the legs or pelvis, cutting off part or all of the blood flow. If the clot then travels to the lungs, a pulmonary embolism can occur.

The company continues to face lawsuits.

Pradaxa is currently approved by the FDA to treat atrial fibrillation, and has been since 2010. However, a safety announcement was issued by the agency in December 2011 following reports of a potential bleeding risk to users. Side effects of Pradaxa have allegedly included internal bleeding and heart attack, and the company continues to face lawsuits alleging that the drug is unsafe and can lead to serious injury. An FDA recall has never been issued.

Lawsuits – now numbering in the hundreds – have been filed against Boehringer Ingelheim alleging that Pradaxa can cause irreversible bleeding in kidneys, the intestines, and other organs. The company has also been accused of failing to warn patients and physicians of the risk, despite knowing that the effects of Pradaxa-induced blood thinning cannot be reversed in an emergency situation.

In August 2012, Pradaxa lawsuits across the country were brought together in a Multidistrict Litigation (MDL) to be heard by Judge David Herndon in the Southern District of Illinois. In June, the first bellwether trial – a series of four or five preliminary trials designed to act as an indicator of future trends in litigation – was selected and the date of the first hearing set for August 2014. Boehringer and plaintiffs are now preparing paperwork and documents before beginning the depositions of Boehringer officials.

Regardless of this, the use of Pradaxa remains widespread, with the company reporting almost $800 million in worldwide sales for the first half of 2013. For patients who believe they were harmed by the drug, an application for its more widespread use will be worrying indeed. The company, however, insists that Pradaxa is effective when used as intended.