European regulators say the upside of blockbuster drug Pradaxa still outweighs its the risks of fatal bleeding, but they want some more labeling caveats for the blockbuster drug.
The European Medicines Agency, or EMA, today said its safety committee has kept a close eye on post-marketing data for the blood thinner. While bleeding is serious complication, “the frequency of occurrence of fatal bleedings with Pradaxa seen in post-marketing data was significantly lower than what was observed in the clinical trials,” it reported. Its solution is clearer guidance to patients and doctors about its risks.
The anti-coagulant drug from Boehringer Ingelheim, is one of a new generation of rivals to warfarin, known by brand-name Coumadin, which dominated the market for 50 years but with a long list of shortcomings. Pradaxa this year hit the $1 billion sales range and helped the company report a big earnings increase.
But Pradaxa and its peers–Eliquis, from Bristol-Myers Squibb ($BMY) and Pfizer ($PFE) and Xarelto from Johnson & Johnson ($JNJ)–have a significant drawback. While warfarin has an antidote–vitamin K–that can reverse its effects, Pradaxa and its new class of rivals do not. That fact has led to a number of cases of fatal bleeding, and some of those have lead to lawsuits from families of patients who claim the risks were not spelled out, reports The Houston Press.
The FDA has also been doing more investigation of these post-marketing events but has, so far, said Pradaxa’s benefits outweigh its risks.