In an apparent bid to position Pradaxa as an improvement on a long-used medication, Boehringer-Ingelheim "withheld from the [FDA's] regulators important analyses regarding how to use the drug as safely and effectively as possible," wrote BMJ's investigations editor, Deborah Cohen.Isn't this the drug in those commercials that claims it's better because you don't have to be monitored?
Today, millions of patients across the globe are taking Pradaxa. As of December 2011 -- about a year after Pradaxa became available -- Boehringer-Ingelheim reported that it had been notified of 9,049 bleeding events among patients taking dabigatran, including 368 deaths. Under the terms set by the FDA and its European counterpart, Cohen wrote, some of those patients may have had their blood over-thinned, raising the risk of bleeding, a problem that might have been averted had regulators required closer monitoring of patients taking the drug.
Oops.
