The BMJ has set off a kerfuffle--and a Twitter campaign--over the safety of Boehringer Ingelheim's blockbuster anticoagulant Pradaxa.
German giant Boehringer Ingelheim is racing to the market with an antidote to its blockbuster blood-thinner Pradaxa, securing the FDA's coveted breakthrough therapy designation for its in-development treatment.
In keeping with the FDA's recent approval, the European Commission has green-lighted Boehringer Ingelheim's clot-fighter Pradaxa to treat and prevent the recurrence of deep vein thrombrosis and pulmonary embolism, a nod that will boost Pradaxa as it battles it out in the anticoagulant market.
Boehringer Ingelheim has agreed to pay $650 million to wrap up thousands of lawsuits claiming Pradaxa, an anticoagulant, caused serious--even fatal--bleeding in some patients. The deal comes just weeks after the FDA completed a safety review of the drug, concluding that it was as safe as the older drug it seeks to replace, warfarin.
It turns out that Boehringer Ingelheim's popular anticoagulant Pradaxa is safer than many people think. That is the finding of the FDA after taking another look at the side effects of the drug compared to the old standard warfarin and this time looking at a much larger and older patient base.
Pradaxa may not be leading the new-age anticoagulant market, but it's certainly leading Boehringer Ingelheim's growth efforts. The blockbuster med made significant gains in 2013 to help offset currency effects and keep operating income up in the face of dwindling sales, the company said Tuesday.
Boehringer Ingelheim, determined not to let clot-fighter Pradaxa be outdone by Bayer and Johnson & Johnson's Xarelto, has added a couple of new uses to the drug's label, snagging the FDA's okay to treat deep vein thrombrosis (DVT) and pulmonary embolism (PE) in some patients. But it still has a long way to go--and some safety concerns to dispel--before it can retake the anticoagulant throne.
Is Pfizer and Bristol-Myers Squibb's Eliquis really safer than its competitors? A recent analysis of FDA adverse events reports suggested that it is.
Drugmakers should clean out their data closets and turn over to regulators every bit of research and analysis they have, according to some healthcare experts, who point to documents released in litigation against Boehringer Ingelheim, with the company's blockbuster anticoagulant Pradaxa as prime evidence.
Pradaxa has become a bigger legal headache for Boehringer Ingelheim. The German drugmaker says it's facing more than 2,000 lawsuits in the U.S., filed by patients claiming the anticoagulant drug caused severe or fatal bleeding.