FDA Warns Diabetes Drug Increases Amputation Ris
If you’re one of the millions of people with Type 2 diabetes and you take medication, the world just got a little scarier.
There have been a slew of new diabetes drugs released over the past decade, each more pricey than the last but seldom more effective than what’s already on the market. Each one has been heavily marketed through direct-to-consumer advertising, and though many of them have had downright chilling side effects, those effects have been downplayed. Even the most frightening side effects—such as heart failure or cancer—have been relegated to the high-speed warning at the end of commercials, followed by a cheerful “Ask your doctor about this drug today!”
And we have. We’ve shelled out thousands of dollars and taken our pills like we’re told, blissfully ignorant of the dangers. So far, those life-threatening effects have included heart attacks (Avandia), heart failure (Januvia), cancer (Actos, Victoza) and pancreatitis (Januvia). But there’s an even more chilling side effect to one of these lucrative new drugs. Two new studies show that diabetes drug Invokana--also marketed as Invokamet and Invokamet XR—nearly doubles diabetics’ risk of needing part of their feet or legs amputated.
Big Pharma doesn’t care if you lose a limb as long as your insurance keeps paying
If you or someone you care about has diabetes, you already know the terror that the specter of amputation holds. And if you have even the most basic familiarity with diabetes, you probably know that amputation is already a fairly common complication of the disease in its later stages. So you’d think that anything which increases this risk—especially if it actually doubles the risk—would be taken very seriously, right?
And since one of the goals for Type 2 diabetes treatment is to avoid complications such as amputations, you might expect doctors to stop prescribing a drug that doubles their likelihood. In fact, it wouldn’t be unreasonable to expect the FDA to pull this drug from the market. Or at the very least, for direct-to-consumer advertising to be pulled.
Not surprisingly, none of these things is going to happen. At around $450 per month, Invokana under all its names is a big money-maker for manufacturer Johnson & Johnson and they’re not about to give that up. And the FDA, dependent as it is on Pharma funding, isn’t about to make them, no matter how compelling the evidence is.
And it is compelling. In first study, which included 4,330 people and lasted one year, 5.9 people out of each thousand taking the drug needed amputations. That’s only about 24-25 people out of 4,330. But...Only 2.8 (or about 11 people) out of each thousand taking a placebo had something amputated. The drug users had more than double the rate of placebo users.
That’s pretty frightening.
The second study showed the same results. This study also lasted a year, and enrolled 5,814 people in total. Of those taking the drug, 7.5 out of every thousand (about 44 people) underwent amputations, compared to about 22 people using the placebo.
And here’s the thing which makes these studies even more shocking: neither of them was intended to study how often amputations happened. Both studies—joint ventures between Janssen Research & Development and The George Institute for Global Health, Australia—were designed to study the cardiovascular effects of this particular drug. But the discrepancy in amputation rates between the groups was so glaring it couldn’t be ignored.
Except...it actually could. In the face of this evidence, the FDA’s only action has been to add a “black box” warning to the drug, stating that it can increase the likelihood of amputation and counseling doctors to take past health history (such as prior amputations) into account when prescribing. The also urge doctors and patients to be alert for the signs of problems that could lead to amputation, such as diabetic foot ulcers.
So in a nutshell: rather than pulling a dangerous drug from the market (and losing billions of dollars in profit for Johnson & Johnson), FDA is issuing a warning that few people—even doctors—will read and even fewer will read.
I certainly feel like my health is in safe hands, don’t you?
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