FDA Announces Changes to Statin Drug Labeling

by Colin Carmichael

There's been a lot of hype and hoopla surrounding the recent announcement by the FDA about safety changes in labeling for cholesterol-lowering, statin drugs.

At first glance, it seems like a major 'victory' for those of us who have been warning of the dangers and risks of these medications for years.

I say that because the FDA has publicly acknowledged in a news release that unwanted cognitive (brain related) effects and increases in blood sugar levels have been reported with using statin drugs.

Finally!

We've known about the potential serious problem of memory loss while using statin drugs for years now.

So it seems like the FDA is finally recognizing the dangers of using these drugs, right?

I'm not so sure.

First off, they appear to go out of their way to try and mitigate the seriousness of these effects on users.

Regarding the cognitive effects, they add…

These reports generally have not been serious and the patients’ symptoms were reversed by stopping the statin.

I wonder…

Do you think the thousands upon thousands (millions?) of folks who have suffered memory loss and other cognitive dysfunction would agree that it wasn't serious?

Here's another excerpt that just so happens to be the first change mentioned in the release:

The drug labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins.

This change scares me and if you're considering one of these drugs … should scare you too.

What's especially troubling on this is the very next line where they say:

FDA now recommends that liver enzyme tests should be performed before starting statin therapy, and as clinically indicated thereafter.

So they still seem to recognize the importance of monitoring liver enzymes for statin users, but apparently the risk isn't high enough to make us aware of it on the labeling.

Anyone else have a problem with that?

Of course, there's another aspect to this story which I haven't seen discussed…

How many doctors will explain and discuss these reported side effects and risks with their patients before sending them out the door with a statin prescription?

That's why I encourage you to do your own research. Get the facts. And find ways how to lower cholesterol naturally before diving headfirst into one of these drugs.


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