One day after U.K. cost-effectiveness gatekeepers gave a preliminary recommendation for its new blood thinner, Boehringer Ingelheim said about 50 patients using the drug have died since its launch last year. The company is investigating the individual deaths, Bloomberg said, quoting the German newspaper Die Zeit.
Pradaxa is one of a new generation of clot-fighting drugs intended to replace the old standby warfarin. The new oral meds are intended to be easier to use than warfarin, which requires constant monitoring and dosage-tweaking. Their one drawback is a lack of a quick-acting antidote. Warfarin's blood-thinning effects can be quickly reversed with Vitamin K in an emergency.
Serious bleeding is always a worry with blood thinners. Pradaxa's bleeding risks are considered to be about on par with another new warfarin alternative, Xarelto, marketed by Bayer and Johnson & Johnson ($JNJ). But Pradaxa's potential to trigger dangerous bleeding appears to be greater than the risk with Bristol-Myers Squibb ($BMY) and Pfizer's ($PFE) prospective entrant into the market, Eliquis.
The number of deaths is within the range that would be expected, based on clinical research that supported Pradaxa's approval, a Boehringer spokesman told Reuters. "Fifty cases is a reasonable order of magnitude that has emerged so far," the spokesman added.
The disclosure comes after Japanese regulators asked the company for additional warnings about potentially deadly bleeding with Pradaxa use, and after Boehringer and European watchdogs advised that patients' kidney function be tested to help reduce the risk of bleeding. Of those estimated 50 deaths, 14 occurred in Japan.