Although Pradaxa is highly effective at preventing blood clots that can cause strokes in such patients, until now there has been no way to reverse the drug’s effects.
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As for the unblinded clinical trial (meaning researchers knew which subjects were taking the experimental drug) used to earn Pradaxa approval, POGO notes that “FDA tolerated sloppiness and arguably loose controls on the part of the drugmaker in its management of the clinical trial”.
As blood thinners, Pradaxa, Xarelto and Eliquis are all meant to be more convenient alternatives to warfarin, an oral anti-coagulant that has been sold for more than 60 years but which comes with serious bleeding risks, hard dietary restrictions and the need for routine blood monitoring.
The Food and Drug Administration said it granted accelerated approval for Praxbind “for managing patients taking Pradaxa, in emergency or life-threatening situations when bleeding can’t be controlled”. Experts said injecting the news drug will help to neutralize effects of the Pradaxa, a medication for patients with irregular heartbeats or arterial fibrillation.
She noted that in May 2014, the FDA compared Pradaxa to warfarin (Coumadin, Jantoven, and generics) used by Medicare patients and found that the risks were lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa compared to warfarin. But until now, there were no approved antidotes for any currently approved NOACs. In three late-stage trials, the intravenous therapy charted an immediate, complete and sustained interruption of Pradaxa’s mechanism of action within 24 hours, Boehringer said.
Meanwhile, Boehringer has long maintained that the development of an antidote in no way undermines its faith in Pradaxa’s safety.
In its publicly posted memo announcing and explaining its decision to approve Pradaxa, FDA redacted its assessment of the drug, POGO says.
The FDA also failed to require Boehringer Ingelheim to carry a conspicuous “black box” warning of potentially fatal bleeding episodes, unlike Warafin, a decades-old blood thinner on the market that was required to put the warning on its label, according to the POGO report. The absence of another trial confirming the results of the first “adds a measure of uncertainty,”according to a medical officer in the FDA’s Division of Cardiovascular and Renal Products”.
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-Members of the FDA advisory committee that reviewed and endorsed the drug by a vote of nine to zero had ties to the pharmaceutical industry. Both are produced by Danbury-based Boehringer Ingelheim.
