When the U.S. Food and Drug Administration (FDA) first approved the anti-coagulant dabigatran – sold by German pharmaceutical firm Boehringer-Ingelheim (BI) under the brand name Pradaxa – it was determined that the danger of potentially fatal hemorrhaging was no greater than it was with the old standby, warfarin (Coumadin). Furthermore, there were far fewer drug interactions to worry about, so doctors, especially those specializing in geriatric medicine, hailed the new medication as a near-miracle.
What is at the center of today's Pradaxa lawsuits is the fact that there is no antidote for excess bleeding when things go wrong. Whereas warfarin's effects can be reversed with Vitamin K, the only thing that can be done for a Praxada patient is to administer emergency dialysis. An antidote is being developed by a San Francisco-area drug company and has shown promise, but as of this writing, has yet to be approved for the market. The question behind the Pradaxa lawsuits is whether or not BI executives were aware that there was no viable antidote.
Now, the drug's overall safety has again come under scrutiny at the same time that Pradaxa lawsuits are going forward. One doctor expressed puzzlement, referring to a study showing that “the rate of [Pradaxa] bleeding post-marketing to be similar to what was seen in the RELY trial.” There were some questions about the RE-LY study, which was carried out in 2009 – not the least of which was the revelation that the lead researcher of the RE-LY study had “significant financial ties” to BI.
The FDA's new investigation into Pradaxa's safety will include patients as young as twenty-one years, will account for age and gender differences and will follow subjects as long as they are taking the medication. This should have little effect on Pradaxa lawsuits, however.
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