While Doctors And Hospitals Handle Patients Having Serious Bleeding Events From Pradaxa, The Drug Company Along With The FDA Still Say All Is Fine, Here
There was a flurry of activity in the first eight days of November 2012 on the issue of whether Pradaxa (dabigatran) is an unsafe drug or a great improvement over Coumadin (warfarin).
We will present the developments in chronological order and you can read from the original source for those items of particular interest to you.
November 2, 2012: "Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events" (MedWatch Safety Alert):
EXCERPT: The results of this assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial).
November 2, 2012: "A Promising Drug With a Flaw" (New York Times article)
EXCERPT: Dr. Bryan A. Cotton, a trauma surgeon in Houston, had not heard much about the new anticlotting drug Pradaxa other than the commercials he had seen during Sunday football games.
Then people using Pradaxa started showing up in his emergency room. One man in his 70s fell at home and arrived at the hospital alert and talking. But he rapidly declined. “We pretty much threw the whole kitchen sink at him,” recalled Dr. Cotton, who works at Memorial Hermann-Texas Medical Center. “But he still bled to death on the table.”
Unlike warfarin, an older drug, there is no antidote to reverse the blood-thinning effects of Pradaxa.
“You feel helpless,” Dr. Cotton said. The drug has contributed to the bleeding deaths of at least eight patients at the hospital. “And that’s a very bad feeling for us.”
November 3, 2012: "AHA: No Excess Bleeding Risk with Dabigatran" (MedPage Today report)
EXCERPT: David Callans, MD, associate director of electrophysiology at the University of Pennsylvania Health System in Philadelphia, said that he hadn't been overly concerned with the reports of excess bleeding because it was not a problem detected in RE-LY....
An important issue, Callans said, is making sure that the drug is being used appropriately.
"A lot of the excess bleeding that was seen and the early furor over that was from people who were getting the drug but shouldn't have gotten it," he said.
The intricacies of patient selection are not always well known among all practitioners in the early days after a drug's approval, he said, resulting in some clinicians prescribing the drug when they're not completely familiar with it.
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November 7, 2012: "Long-term study reinforces safety record of blockbuster Pradaxa" (FiercePharma story)
EXCERPT: Dr. Connolly, a professor in the Department of Medicine at McMaster University, Ontario, Canada.... said the concern about antidotes misses the larger context. "If you use dabigatran you are going to prevent or significantly reduce the larger, more serious bleeds compared to warfarin and you are also going to reduce ischemic stroke, and the overall benefit would seem to clearly outweigh the concern that a patient might get into a situation, where they might need an antidote, that might have worked if they were on warfarin."
November 7, 2012: "Interim Results from RELY-ABLE®, the RE-LY® Extension Study, Provide Additional Clinical Evidence for the Safety of Pradaxa® (dabigatran etexilate mesylate)" (Drug company Press Release)
EXCERPT: Boehringer Ingelheim Pharmaceuticals, Inc. today announced interim results from the RELY-ABLE® trial, a long-term extension of the RE-LY® study. During more than two years of randomized follow-up, key safety outcomes such as major bleeding, total bleeding and life threatening bleeding were similar to the results of the dabigatran 110mg* and 150mg arms of the pivotal RE-LY trial that evaluated Pradaxa® (dabigatran etexilate mesylate) capsules in patients with non-valvular atrial fibrillation (NVAF). There were no new safety findings identified in the interim study results. These data were presented today at the American Heart Association's Scientific Sessions 2012.
November 8, 2012: "AHA: Pradaxa Safety Appears Durable" (MedPage Today report)
EXCERPT: Robert Giugliano, MD, of Brigham and Women's Hospital in Boston, who served as a discussant following Connolly's presentation, said that observational registries -- which is essentially what RELY-ABLE is -- can provide complementary information to randomized clinical trials.
Although RELY-ABLE was limited in that it included only about one-third of the total patient population from RE-LY (including the warfarin group) and that the patients in the extension phase were likely different from those in the main trial, Giugliano said, it does provide some take-home messages.
"If patients cannot take or refuse a traditional vitamin K antagonist, I think a novel oral anticoagulant is a good option and we now see from RELY-ABLE longer term results that look quite favorable," he said. "And so I think that's a reasonable treatment [alternative] to vitamin K antagonists," he said.
Of course, we will continue to monitor the safety profile of this controversial, still relatively new blood thinner Pradaxa and report significant developments here.
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