Patients go on bleeding to death as antidote sought for defective med
Deadly drug keeps killing while Big Pharma searches for an antidote
Dear Reader,
It was one of the most irresponsible and dangerous things the FDA has ever done. It was bad enough that it approved this horribly dangerous drug in the first place. But to do it without having an antidote in place practically accounts to murder.
Before the very first Pradaxa pill was ever swallowed, an antidote to stop the uncontrollable bleeding it can cause should have been available.
But it wasn’t.
And there have been thousands of serious bleeding events and more than 1,000 deaths because of that.
Finally, Boehringer Ingelheim, the German company that makes this deadly blood thinner, has just announced that it’s forging ahead with work on an “investigational antidote.”
And the FDA has given this “breakthrough therapy” status. That means it’s getting fast-tracked through the agency for approval ASAP.
Of course, any antidote they come up with now will be too late for many who had no idea that taking Pradaxa would be a death sentence.
It was a little detail the FDA and Boehringer never bothered to warn us about.
When Pradaxa was approved by the FDA in 2010 the agency called it a lifesaver.
But ask any ER doctor who can only stand by helplessly while waiting to see if his patient hemorrhages to death. You might get a far different opinion.
In its recent news announcement, Boehringer said that an antidote will “give physicians an additional…option beyond the already existing measures” to stop Pradaxa bleeding.
Really, Boehringer? What other “existing measures” might those be?
The only possible “option” doctors have, according to trauma surgeon Dr. Bryan Cotton, is to perform “rapid dialysis” to clean someone’s blood of the drug. And the only chance you have with that is if you can get them into the ER fast enough. Even so, Dr. Cotton calls that idea “an incredible challenge, even at level 1 trauma centers.”
But even without an antidote, there was one small thing the FDA could have done to make this deadly drug safer to use.
Notice that I said “could have done…”
Experts have been pleading with the FDA to pull Pradaxa off the market. But the agency did exactly what we’ve come to expect: a complete 180.
This spring, the agency quietly gave the okay for close to a million more of us to take Pradaxa. That’s because it’s now being prescribed for blood clots in the legs and lungs.
That approval will no doubt open the floodgates to even more tragedies.
And Pradaxa will be prescribed for those new conditions at the same dangerous dose as for those who have A-fib. A dose that experts have been asking the FDA to lower since 2010.
When the FDA allowed Pradaxa on the market, it approved a “one dose fits all” of 300 mg a day. And it did that despite early warnings that a dose that high would cause major bleeding events in many people. Especially high risk patients — like the elderly.
Thomas Moore, senior scientist at the Institute for Safe Medication Practices, put it this way: “There was an opportunity to make it safer. Instead it appears that the commercial instincts to sell more drugs won out.”
And right away, Moore’s group saw a “strong signal” of “serious adverse drug events” coming into the FDA about Pradaxa. They found “large numbers of serious and fatal reports of bleeding,” especially in older people.
The group asked the FDA to reconsider that large dose and to improve its monitoring of high-risk patients.
They also asked the FDA to do what regulators have done in Canada, Australia, New Zealand, Japan and Europe — make a lower dose available to doctors.
But the FDA refused to budge and lower the dose.
And now, Boehringer is finally getting around to work on an antidote, after almost 5 years and millions of Pradaxa prescriptions.
But actually, there’s been an antidote for Pradaxa all along. And it really works.
Avoid it at all costs.
Sources:
“Breakthrough status for BI’s Pradaxa antidote” Kevin Grogan, June 27, 2014, PharmaTimes, pharmatimes.com
