"Pradaxa was introduced in 2010," Lowe says. "It is used for patients who need anticoagulation, particularly heart attack and stroke victims. The previous drug typically used was warfarin. The problem with Pradaxa is that it has been associated with uncontrollable bleeding and has no antidote. With warfarin there was an antidote, vitamin k. Any anticoagulant has a risk of bleeding, but older drugs have an antidote for that bleeding. So if someone has uncontrolled bleeding while taking Pradaxa and they go to the hospital, they have to let the bleeding run its course."
Despite only being on the market a short time, Pradaxa has reportedly had a high number of adverse event reports filed. Lowe says the number of reports filed is likely low compared to the number of actual adverse events.
"Since Pradaxa has been on the market, there have been about 4,000 adverse drug event reports, which is a lot," Lowe says. "Typically, it is accepted in epidemiology that for every one incident that is reported to the FDA (Food and Drug Administration) there are probably 100 more that are unreported. This is because the doctor has to make the connection between the event and the drug, fill out a form and send it to the FDA. So it's accepted that these things are underreported. There have also been 600 deaths reported to the FDA."
The FDA has not currently taken any action regarding Pradaxa, aside from reviewing the data. So far, no black box warning or recall of the drug has been announced. Lowe says that some overseas drug-monitoring agencies have required warnings about Pradaxa be sent out to doctors. Even though the FDA has not taken action, Lowe says lawsuits have been filed in the US regarding Pradaxa.
"There has been a multi-district litigation recently set up," Lowe says. "All the federal lawsuits have been consolidated in the South District of Illinois, with Judge Herndon overseeing the lawsuit. That was about two weeks ago, so the multi-district litigation is just starting out."
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"They need to talk to their doctor about whether it's worthwhile being on the drug versus being on an older generation anticoagulant," Lowe says. "The benefit is that it's only taken once a day, so it's easier for compliance. But they need to know the risk, which is if there's bleeding, it's hard to stop. I had a client who was in hospital and almost died. He had to have a transfusion of eight pints of blood. They had to stop the drug and wait for it to be out of his system before they could start coagulating."