FDA fast tracking of drug approval is a speedy road to ruin for many patients
Out with the new
Even if you’ve never taken it, you’ve probably heard of warfarin. The FDA approved this blood thinner when Eisenhower was president.
On the other end of the Old-New spectrum, we have another blood thinner: Pradaxa. It hit the market during the early Obama years.
“Hit” the market? More like “roared” onto the market. The FDA gave this promising drug the fast-track treatment. It was touted as better stroke prevention than warfarin. It also appeared to cause less hemorrhaging.
So it moved quickly. It was a lifesaver!
That was in 2010.
By the end of 2011, Pradaxa was a monster. Even ice-cold FDA officials must have felt a chill when they saw these year-end adverse event numbers…
* Strokes — 644
* Kidney failures — 291
* Hemorrhages — 2,367
* Deaths — 542
Pradaxa also topped all other drugs in number of reports to the FDA that year — 3,781.
Meanwhile, warfarin was associated with 72 deaths in 2011. That’s tragic. But it’s not even in the same ballpark as Pradaxa.
The worst of it is that someone should have seen it coming.
You see, warfarin has an antidote. If hemorrhaging occurs, vitamin K1 stops the bleeding. But that’s not the case with Pradaxa. Once a hemorrhage starts, it’s almost impossible to stop. And the results are almost always tragic.
Now to most of us, that would be a clear warning that things might go horribly wrong. But that’s the kind of critical safety detail the FDA throws in the circular file on its way to the fast track.
Really, there’s only one way to protect yourself: NEVER take a new drug. Every year, we see this same sad story. Pradaxa. Mylotarg. Avastin. Chantix.
And fast track drugs aren’t the only dangers. Vioxx, statin drugs, and many others pre-date the fast track option. They prove that, with the FDA holding the “approved” stamp, ANY new drug is risky business.
Sources:
“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
