FDA finally requires diabetes drugs to carry heart failure warning
There seems to be a contest among drug companies to see who can make the most dangerous diabetes med.
And I can’t say for sure who’s winning — but millions of diabetics are coming up on the losing end, big time.
Over just the past couple of weeks, I’ve warned you about diabetes drugs that have been linked to everything from seizures to cancer.
Now even the FDA is admitting that two popular diabetes meds — ones you might be taking right now — could actually be slowly shutting down your heart.
And of you’re not careful, they could have you on the fast track to an early death.
In fact, I even said that it might be the most dangerous drug ever approved for diabetics.
But during all that time, the FDA hemmed and hawed about the risks.
And finally, last week it made the announcement we’d all been expecting. Taking Onglyza, as well as the generic diabetes drug alogliptin (you’ll also see it sold under the brand name Nesina), significantly ups your risk of heart failure.
But for untold numbers of diabetics, this big announcement is a day late and a dollar short.
Because especially with Onglyza, it’s no secret that it can seriously affect your heart.
In fact, the FDA had concerns about that right out of the gate when the drug was first approved back in 2009. But to “prove” that risk, it ordered AstraZeneca to do a “post-marketing” study.
I’ve told you about these shameful studies before. They let a drugmaker keep selling a med while it figures out exactly how dangerous it is.
In other words, we all become guinea pigs — with Uncle Sam’s blessing.
AstraZeneca’s big study, called SAVOR (don’t you love those names!), wrapped up a few years ago. But nobody was “savoring” the results — and everyone has just been sitting on them ever since.
SAVOR found that Onglyza won’t keep you from suffering some of the deadliest complications of diabetes, like having a heart attack or stroke. In other words, it doesn’t work very well. But it did discover that Onglyza can increase you overall chances of dying.
And it can send your risk of heart failure through the roof, especially if you already have heart or kidney issues (and lots of diabetics do).
Now, you would think that would be enough to cut the cord on Onglyza. I mean if a drug doesn’t help your condition — and could even kill you — the only thing the FDA should be saying is “game over.”
But it obviously hasn’t. Onglyza is still selling to the tune of over $800 million every single year.
Which brings us back to the FDA’s latest communication.
You see, last year an expert panel convened to give the agency its opinion on what to do with Onglyza.
Yes, the patients who took it had a higher risk of dying, but what the group was really concerned about was that increase in heart failure. And it voted almost unanimously to require a warning about that on its label (in fact, one member voted to ban the drug completely).
Now, a full year, and millions of sales later, the FDA has finally told AstraZeneca that the risk of heart failure must be added to the Onglyza label. And after taking another look at the research, they’re throwing the warning on alogliptin, too.
But really, is anyone taking Onglyza or alogliptin, perhaps for years now, going to suddenly start reading the book-length paperwork that comes with them? Unfortunately, most patients are just going to keep popping the meds like they always have.
And unless we all speak up, doctors aren’t very likely to stop prescribing either med.
If you or someone you love is taking Onglyza or alogliptin, it’s time to have a conversation with your doc right away.
Because making a fortune off of dangerous diabetes drugs may be a big game to Big Pharma — but it’s one that none of us should be playing any more.
Sources:
“FDA warns of heart-failure risk with two diabetes drugs” Miriam E. Tucker, April 5, 2016, Medscape, Medscape.com
