The assessment, on the surface, may have served as an attempt to vindicate the FDA in the face of criticism over the approval of Pradaxa (dabigatran etexilate mesylate), which is far easier to monitor than the older warfarin.
However, as noted in the New York Times (11/3/12), the report did not reference the serious attribute of dabigatran Pradaxa that once bleeding starts, it's almost impossible to stop. The problem with Pradaxa is not shared by warfarin: doctors have tools available to stop uncontrolled bleeding in warfarin patients. Such an antidote does not exist with Pradaxa. At least not yet.
It's something Dr. Bryan Cotton, a trauma surgeon based in Houston, has seen first hand and knows all too well. "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."
Dr. Cotton tells the story of one elderly Pradaxa patient who fell at home, and while he was described as alert and talkative when he arrived at hospital, his condition deteriorated rapidly, and he soon died. "We pretty much threw the whole kitchen sink at him," recalled Dr. Cotton, who treated the patient at Memorial Hermann-Texas Medical Center in Houston. "But he still bled to death on the table."
The New York Times reported that no fewer than 542 Pradaxa deaths have been linked to Pradaxa—either due to bleeding or Pradaxa heart attack—in 2011 alone. The Institute for Safe Medication Practices notes that Pradaxa was also linked to more reports of injury or death than any of the more than 800 drugs the not-for-profit agency regularly monitors.
Pradaxa has only been on the market since October 2010 and was quickly embraced by doctors for the ease of monitoring, with fewer dietary restrictions than Coumadin (warfarin).
In reference to Pradaxa side effects, manufacturer Boehringer Ingelheim stands behind Pradaxa as safe. "The evolving spontaneous reporting patterns do not indicate a change in the favorable benefit-risk profile of Pradaxa," the German drug maker said in a statement, "when used correctly according to the approved label."
The FDA is correct in that bleeding is also possible with warfarin. However, with the latter, bleeding can be stopped with the administering of vitamin K or other substances.
There is no such antidote for dabigatran Pradaxa. The FDA approved it anyway. "The lack of an antidote notwithstanding, dabigatran was superior to warfarin in preventing strokes in a large clinical trial. The rates of bleeding were similar," the FDA said in a statement.
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"The problem is that the people [who] prescribe this, as a general rule, are cardiologists and family practitioners," said Dr. Mosley. "The people that see the harm are your ER docs and your trauma docs."
Walter Daumler lost his sister Doris, 78, to uncontrolled Pradaxa bleeding. She bled to death this past May. Daumler told the New York Times he has hired a lawyer and is considering a Pradaxa lawsuit. "My [Number One] goal is to stop this insidious drug," Daumler said. "To get this off the market, so others will not undergo or witness what I saw."