It’s another case of a fast-tracked drug approval that turned millions of us into guinea pigs.

And now, four years later, we’re finally learning more about the blood thinner Pradaxa. Unfortunately, it’s four years too late for many of us.

It was first approved for people with A-fib, and it looks like those are exactly the ones this med harms the most.

A recent study at the University of Pittsburgh of over 9,000 Americans found that those taking Pradaxa who had A-fib, had a much higher risk of a major “bleeding event,” especially in the GI tract, than those who were taking the older blood thinner, warfarin.

And remember, that’s the condition this drug was approved to treat by the FDA in the first place!

Dr. Rita Redberg, the editor of the journal JAMA, where the study was published, said that this is “cause for concern” as the bleeding risk is “significantly greater than originally appeared at the time of the FDA approval.”

But what was known at the time Pradaxa was approved by FDA, is that once you start bleeding, there’s no way to stop it.

And that can make taking Pradaxa a death sentence.

Finally, after thousands of serious bleeding events and over 1,000 deaths from the drug, Boehringer Ingelheim, the German company that makes it, is just now starting a trial to see if its “investigational” antidote will work.

According to the drug maker, this trial might take a very long time to complete. But don’t worry — somehow Boehringer believes that in “real-world” situations, the chance of someone really needing this antidote is “rare.”

And anyway, Boehringer says, its drug has been humming along for some time now without an antidote. So this is just “an additional therapeutic option to be considered.”

Based on my research, there is absolutely no reason to risk taking Pradaxa. The risks are far too great — and the benefits are far too few.

Sources:
“Beware of blood thinner Pradaxa, study warns” November 3, 2014, Newsmax Health, newsmaxhealth.com


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

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