Type 2 diabetics at risk with approval of dangerous new drug
New drug throws millions more diabetics into Big Pharma’s crosshairs
It’s been a heck of a year so far for those with type 2 diabetes.
It’s not enough you’re told to monitor almost every bite you take. Now you have to be on extra high red alert when it comes to the drugs that are supposed to help you.
Because in addition to the other drugs I’ve warned you about already, the FDA has just approved the third in a trifecta of dangerous drugs aimed right at the people who need them the most.
I’ve warned you before about the risks of taking new drugs, but we know this one is bad right out of the gate. It’s a newbie with some horribly dangerous side effects.
And it also comes from a family of equally risky drugs.
So if you have type 2 diabetes, and your doctor wants to talk with you about a brand new treatment, here’s what you need to know first.
It’s called Jardiance, but what the industry calls it isn’t quite so fancy-sounding. This new drug is known as an SGLT2 inhibitor.
It works by forcing your kidneys to excrete glucose in your urine. And it’s the third type 2 drug approved by the FDA this year that works like that. I guess Eli Lilly and its partner, German drug maker Boehringer Ingelheim, wanted to get on the SGLT2 bandwagon as fast as possible.
Now that may sound like a simple way to lower your blood sugar levels, basically just pee out all that sugar.
But unfortunately, it’s not that simple.
The result of doing that can be severe dehydration, which can lead to a deadly drop in blood pressure. And lowering your blood pressure like that can also cause dizziness and falls.
And if you have reduced kidney function, are taking diuretics, and are over 75 you are “more susceptible to this risk.” And that warning comes straight from the FDA.
Of course, the ones most in jeopardy for reduced kidney function are diabetics.
But even if your kidneys are in great shape, experts say this method of blood-sugar control can cause “a cascade of adverse events.”
And as bad as they sound, dehydration and dizziness aren’t the only problem with Jardiance.
What about urinary tract infections? That’s the most common side effect reported for this drug. Lilly and Boehringer say that 1 in 10 “may” get a UTI from it. But experts believe that number will be much higher.
There’s also the common side effect of genital infections in women.
And all these SGLT2 inhibitors can put you at risk for serious kidney and heart problems as well. Actually, the FDA, Lilly and Boehringer really have no idea just how much damage this drug might do to your heart.
But the FDA has that little problem under control. It will be taking a good look at data sometime in the future when the “cardiovascular outcome trial” is completed. In the meantime, docs are free to prescribe away.
Not that those are the only “post marketing” studies in the works. Because it looks like kids may be in the Jardiance crosshairs, too.
The FDA has asked Boehringer to do three pediatric studies to see if Jardiance will interfere with a child’s bone and kidney development.
But we know that however those studies turn out, the FDA will give it a thumbs up. And the idea of kids being given this dangerous drug — one that may adversely affect developing hearts, kidneys and bones — is just too horrible to imagine.
Back in March, the FDA refused to approve Jardiance. It said that the German plant where it’s going to be made had some “deficiencies.” But magically, all that was resolved in a few short months.
But the Jardiance “score card” will take much longer than that to come in.
It will take years, likely decades, of “post-marketing data” before we learn how many millions of us with type 2 diabetes will have been seriously harmed — or killed — by this drug.
Sources:
“FDA approves Jardiance to treat type 2 diabetes” FDA press release, August 1, 2014, fda.gov
“Lilly, Boehringer win FDA approval for once-rejected diabetes drug” Damian Garde, August 1, 2014, FierceBiotech, fiercebiotech.com
