The FDA just made this risky blood thinner even more dangerous

Warning: Deadly drug gets green light to kill even more of us

Dear Reader,

It’s already a known killer with a rap sheet a mile long.

Since its approval in 2010, it’s caused over 12,000 serious injuries and been linked to over 1,000 deaths.

Yet it’s still widely available — and about to be prescribed to even more of us.

Because the agency so many naïve Americans think is here to protect us, the FDA, chose to open the floodgates for even more of us to be prescribed this deadly drug. Close to a million more.

And the biggest tragedy is that the agency could have done one small thing that would have made it safer to use.

Only it didn’t.

“It is a great tragedy in medicine and the regulation of drugs.” That’s what Thomas Moore, the senior scientists at the Institute for Safe Medication Practices, said about the dangerous blood thinner Pradaxa.

The first two years it was on the market, the FDA received more reports of adverse reactions about it than any other prescription drug.

But despite all the deaths from bleeding, serious injuries, lawsuits and the fact that there is NO antidote if you start to hemorrhage from it — the FDA has just okayed it for more uses.

That means the injury and death toll will climb even higher.

Over 8 million prescriptions have already been written in the U.S. for people who have A-fib — the chaotic heart rhythm that raises your risk of having a stroke.

And that’s led to over 2,300 lawsuits for death and injury against Boehringer Ingelheim, the German company that makes it.

But while company bigwigs must have been wringing their hands over all those lawsuits and the big bucks they’ll have to pay out, it hasn’t all been bad news for BI.

Because the FDA gave them the green light to sell even more Pradaxa. Much, much more.

By quietly okaying its use for two more conditions — blood clots in the legs and lungs — the FDA will be making that list of tragedies much longer. And it approved the drug for those conditions not because it was better than the old standby warfarin, but because studies showed it wasn’t any worse!

The big danger is that 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.

“There was an opportunity to make it safer. Instead it appears that the commercial instincts to sell more drugs won out,” said Moore.

When the FDA allowed Pradaxa on the market four years ago, 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.

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 stuck with the super-high dose. The benefits outweighed the risks, it said.
Only they didn’t. And they don’t.

That was the first deadly mistake. The second was to put so many more people in harm’s way with Pradaxa. All at the same mega-dose.

“The drug now needs to be reassessed. It’s not clear that it is safe,” Moore said.

But since the FDA is busy giving your doctor more reason to write a script for Pradaxa, it doesn’t look like a “reassessment” will be coming any time soon.

The company that makes Pradaxa said it was pleased to be able to offer the drug for these extra uses to address patient “needs.”

But the only real “need” a patient has is to avoid this deadly drug in the first place.

 

Sources:

“UPDATED: Boehringer’s Pradaxa fights to regain ground with new clot-fighting approval” Carly Helfand, April 8, 2014, FiercePharma, fiercepharma.com

“How FDA can help reduce dabigatran (PRADAXA) bleeding risks” February 13, 2014, ISMP medication safety alert, ismp.org