Pradaxa is just too dangerous

Boehringer Ingelheim, the pharma company that makes the blood thinner Pradaxa, has tallied that to be around $162,000. Its settlement of $650 million two years ago swept away 4,000 state and federal lawsuits for Pradaxa victims, both dead and alive. Despite that -- and a laundry list of other things such as bogus marketing claims, incriminating top-secret memos, and a scathing critique of the FDA for even approving it in the first place -- Pradaxa keeps right on selling. Now, a consumer group is saying enough is enough, and warning people everywhere: "Do not use" Pradaxa. ---------------------------------------------------------------------- Blood money ---------------------------------------------------------------------- If you've watched television for more than ten minutes lately, you've seen the Pradaxa commercial with the red fish. Those fish are supposed to be your blood cells -- they either go swimmingly along in your arteries or group together to make a blood clot. But when I tell you that there's something fishy about Pradaxa, believe me, it's more than a really bad pun. When Pradaxa first came out, its big selling point was that you wouldn't need to have routine blood testing as you do for the old standby blood thinner, warfarin. It's new and improved! Except that really wasn't the case. You see, until very recently there was no antidote or reversal agent for Pradaxa (more on that in a minute). Those lawsuits I just told you about were for thousands who suffered major and uncontrollable bleeding while taking the drug. When those cases came to trial, the judge unsealed confidential documents showing an internal report that proposed some patients should still have regular blood tests to look for bleeding dangers. Even Boehringer's own clinical trial proved that to be true. Plus that, an in-depth report by the Project on Government Oversight found wheeling and dealing by the FDA that made it sound more like the drugmaker's PR firm than a government agency that's supposed to be protecting us. For example: after approving the med based on one single trial, and speeding it to your doctor's office with no antidote, the FDA allowed it to be sold without giving patients and doctors adequate warnings about its very real bleeding dangers. And now, after taking a good look at everything that's gone on with Pradaxa, the group Public Citizen has added the drug to its "Do Not Use" list. Saying that while warfarin "has some limitations," the group notes there's an easy blood test that can tell your doctor how much you need -- or don't need. Plus that, in an emergency the effects can be quickly reversed with a simple injection of vitamin K. Which brings us to the latest marketing claim Boehringer is making for Pradaxa. While, unbelievably, it still advertises that you don't need "regular blood testing," you'll also hear that Pradaxa finally has an antidote. But, like everything else with this drug, when you scratch below the surface things aren't quite what they seem. The big trial testing this belated reversal agent, called Praxbind, included just 123 patients who needed an emergency antidote to the blood thinner. Of that number 26 died during the study, some from brain and GI bleeding. And, as Public Citizen pointed out, the lab test to determine just how effective it is at stopping bleeding isn't one that's "routinely available" to doctors. Even the Cleveland Clinic's cardiac head, Dr. Steven Nissen, calls the antidote a way to push Pradaxa sales that "is very expensive" and would only be tried for "catastrophic bleeding." As I said several years ago, Pradaxa is just too dangerous to use. And despite what the manufacturer would like you to believe, it obviously hasn't gotten any safer. To Your Good Health, Jenny Thompson

Health Sciences Institute <HSIresearch@newmarkethealth.com>