Here’s what you need to know about a dangerous new drug for type 2 diabetes

How the FDA pushed type 2 diabetics into big pharma’s crosshairs

What a way to start the new year.

I’ve warned you about the unknown risks of taking new drugs, but this newbie needs no wait-and-see. We already know how bad it is.

The FDA always talks about “risk” versus “benefit” when it approves a new drug. But even they are having trouble with the benefit part of this.

So if you have type 2 diabetes and your doctor says there’s a new Rx you can try, here’s what you need to know…

If at first you don’t succeed…

The FDA’s buddies at Bristol-Meyers and AstraZeneca must have had a heck of a New Year’s party. They had been trying for three years to get approval of Farxiga. Sorry…I have no idea how to pronounce it either but I know this: It “lowers blood glucose by altering how your kidneys work.

At first, the FDA said “no.” It doesn’t use that word very often, so you can imagine just how bad this drug is.

How bad? How about bladder and breast cancer? Or damage to the heart and liver? Or too low blood pressure? Urinary infections, anyone?

At the turn-down meeting last year, FDA officials said women taking Farxiga would up their breast cancer risk by four times. And guys could have a five-time greater chance of bladder cancer.

Still, the FDA also gave the drug makers a little wink and nod at that meeting, praising them for coming up with such an “innovative drug.” One doc went so far as to say that Farxiga is “brilliant in its simplicity.”

But to see how brilliantly wrong it was for the FDA to send this drug to the pharmacy shelf, just hear what they had to say about it the very first time.

Basically, the drug doesn’t work very well.

While the real “benefits” of Farxiga were “modest” at best, it was even less effective for diabetics with kidney disease. And that’s a big problem when we know the number-one cause of kidney disease is…diabetes.

Farxiga works by making the kidneys get rid of glucose, and it keeps them from reabsorbing it too. So it’s no surprise that it doesn’t work too well if your kidneys aren’t working too well.

And that has to make you ask why a drug like this would even be considered for diabetics — the ones who are most at risk for failing kidneys.

And I’m certainly not the only one wondering.

In fact, the FDA said in its rejection letter to the drug companies that as a diabetic’s kidney function decreases, there might be absolutely no benefit at all(!).

Nothing. Nada. No benefit. All risk.

The drug’s makers still have to provide more studies, but those will come long after the fact. That is, after doctors write hundreds of thousands of prescriptions and millions of those pills are popped.

Sources:
“FDA approves new diabetes drug” Cole Petrochko, MedPage Today, 1/8/2014, medpagetoday.com