Is the FDA fast-tracking you…to death?

When Archie and Edith sang “Those Were the Days,” they reminisced about music, their trusted LaSalle, and people pulling their own weight.

If they were to reprise the song today, you might have to add a refrain about…

Blood thinners.

Yes, blood thinners. Let me explain…

Stop the music

Even if you’ve never taken it, you’ve probably heard of warfarin. The FDA approved this blood thinner back when Eisenhower was president and people still had something to sing about.

More recently, the FDA inflicted Pradaxa on us. (Cue the theme from “Jaws.”)

This blood thinner roared onto the market in 2010. The FDA gave Pradaxa the fast-track stamp of approval because it was touted as better stroke prevention than warfarin. And it appeared to cause less hemorrhaging in early trials.

It was literally a lifesaver. Or it was supposed to be.

Just one year later, Pradaxa looked more like a monster. Even the most hardened FDA officials must have been horrified when they saw these 2011 adverse event numbers…

* Strokes — 644

* Kidney failures — 291

* Hemorrhages — 2,367

* Deaths — 542

It’s worth noting that warfarin was associated with 72 deaths that year. And that’s terrible. But it’s not even in the same ocean as Pradaxa.

What’s worse, anyone could have seen this coming — even a mid-level FDA lackey.

You see, warfarin has an antidote. If hemorrhaging occurs, vitamin K1 stops the bleeding. But with Pradaxa, a hemorrhage is almost impossible to stop. And the results are frequently tragic.

According to a new report, the company that makes Pradaxa is developing a hemorrhage antidote. Talk about a red flag! Can you imagine? Your doctor tells you he wants you to take this drug. And oh, by the way, we hope the antidote will be on the market soon.

There are a lot of natural options for blood-thinning, including fish oil. But if you must be on a prescription blood thinner, stick with the classics.

You have a much better chance of getting out alive.

Sources:
“DrugNews Update: Pradaxa Use Could Increase Despite Warnings, Growing Lawsuits” DrugNews, 10/9/13, prweb.com

“FDA-Approved Drug Linked to 542 Deaths and 2,367 Hemorrhages, but FDA Refuses to Pull It” Alliance for Natural Health, 4/2/13, anh-usa.org


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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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