It’s only April’ and this is the third new dangerous diabetes drug I’ve already told you about this year. It’s hard enough figuring out how to beat diabetes without having to dodge all these risky new drugs!
The story said that this new diabetes drug is a “trailblazer.” But what it’s really doing is leaving a trail of pain and suffering.
And there’s no question that the risks of this recently approved Rx for type 2 far outweigh its benefits.
That is’ if there are any benefits at all…
The worst one of all?
It’s called Invokana’ and it’s a “special” kind of med in the same family as another newbie I warned you about in January. It lowers blood sugar by making your kidneys get rid of glucose through the urine.
And that can cause some serious side effects’ especially if you’re older.
In an attempt to stop Invokana’s approval’ Dr. Sidney Wolfe’ director of Public Citizen’s Health Research Group’ went before the FDA’s drug advisory committee last year. Dr. Wolfe presented evidence showing just how dangerous this drug will be for those with type 2.
He warned that the way the drug works’ by eliminating all that glucose in the urine’ “can cause a cascade of adverse events.” These include dehydration’ which can lead to low blood pressure’ dizziness and falls’ and damage to the kidneys and heart.
Even having “moderately” reduced kidney function’ he said’ puts people at high risk with this drug.
And the ones most at risk for failing kidneys — diabetics.
But that’s not all you would have to worry about when taking Invokana.
If you’re also on diuretics like Lasix and are over 75′ you would be in even greater danger of that “cascade” of side effects.
And what was the FDA’s reaction after hearing Dr. Wolfe’s comments?
It was to approve the drug only two months later!
But don’t think just because this risky med was given an official okay that the FDA didn’t know this drug could be very dangerous.
Wait till you hear what it told the drug’s maker’ Janssen Pharmaceuticals.
The FDA actually stated that its usual method of post market review of “adverse events” won’t be “sufficient” to learn if this drug poses a “serious risk” of cancers’ pancreatitis’ bone fractures’ liver damage’ hypersensitivity reactions and “adverse pregnancy outcomes.”
And that’s not the worst…
Instead of holding back until more is known about those risks’ the FDA said that it would be okay for Janssen to sell the drug’ but is “required” to be on the special lookout for all “foreign and domestic” reports of those horrible effects in patients taking Ivokana. And it was given until 2023 to submit a final report about it!
Do I have my math right here? You mean to tell me the plan is to tally up the damage toll for 10 years of diabetics taking this risky drug and then take another look?
And those heart dangers that Dr. Wolfe warned about — well the FDA has not “excluded the potential” of those risks either.
It ordered Janssen to complete a post-market double-blind trial with Invokana to see how many heart attacks’ strokes and fatalities it causes. And they have until 2017 to submit the report on that one.
Now the FDA might tell you that these dangers come with all prescription drugs. It’s that “risk vs. benefit” formula they are always talking about. But in this case’ it looks like there aren’t many benefits to add up’ either.
Dr. Wolfe’s group said that Invokana was approved without showing any “evidence of improvement in clinically meaningful outcomes.”
If there ever was any doubt that the FDA is more interested in helping Big Pharma than consumers’ its approval of Invokana should make that point loud and clear.
And by the time we get to 2023′ how many millions of us with type 2 diabetes will have been seriously harmed — or killed — by this drug while the FDA sits by waiting for the final report on its effects to come in?
“The new diabetes drug canagliflozin (INVOKANA)” Worst pills best pills newsletter’ February’ 2014′ worstpills.org
Letter to Janssen Research & Development from the FDA’ NDA 204042′ March 29′ 2013′ accessdata.fda.gov