Notorious ‘killer painkiller’ comes to America
FDA caves: Puts dangerous pain drug on market
We’ve been lucky so far in the U.S.
Because a very risky NSAID, one just as dangerous as Vioxx, wasn’t very popular here.
This drug, called diclofenac, is big in other parts of the world, mostly third-world countries. That’s where it sells the most.
It’s another one of those COX-2 inhibitors.
But it looks like our luck has run out. The FDA will now allow it to be prescribed here for those suffering from osteoarthritis.
And its big selling point? This “new” drug works at a lower dose.
But don’t be tricked into thinking that means it’s any safer.
Because where this med is concerned, there is no safe dose.
The FDA obviously learned nothing from the Vioxx tragedy — where more than 60,000 people died from a stroke or suffered a heart attack while taking the drug.
Because just last week it gave the green light for millions of us to take a drug that may be just as dangerous — or more.
“Clearly thousands of people die as a result (of taking diclofenac). But these are invisible victims. And therefore, there’s no advocacy lobby group on their behalf.”
That’s what Dr. David Henry said about diclofenac. He was the lead author in a large published study that looked at NSAID drug use around the world.
And what he found out is that where diclofenac is concerned, your heart-attack risk is just as high as for those who took Vioxx — a whopping 40 percent increase.
This drug is so dangerous that Dr. Henry and his team are petitioning the World Health Organization to get diclofenac off its list of “essential medicines.”
But recently this drug has made its way into the U.S. It’s being sold here under the name of Zorvolex.
The first “edition” of Zorvolex was approved last year, to be taken for general “pain.” And then the company that makes it, Iroko Pharmaceuticals, pushed the FDA for more uses, this time for osteoarthritis.
And, of course, the FDA was more than happy to say “Yes.”
It did, however, make Iroko add a black box warning for “serious cardiovascular and gastrointestinal events.” Things like strokes, heart attacks, and stomach bleeding, which can be “fatal.” But how many people really read those book-length labels? Especially after they’ve already waited an hour and paid for their Rx.
And here’s where we can be tricked into thinking that Zorvolex is somehow safer.
It’s being pitched as “different,” a pain reliever “designed” to work at a lower dose.
But even reducing the amount of this drug won’t take away that big risk to your heart.
Because researchers couldn’t find a dose that was low enough to not drastically up your risk of heart attack and stroke.
Not even one milligram!
And that risk gets even bigger if you’re older, have a peptic ulcer, or smoke. Even if your heart is in tip-top shape, diclofenac can still give you hardening of the arteries!
That’s not to mention the big risk to your kidneys and liver and the danger of bleeding and perforation of your GI tract…which “can be fatal.”
Now the FDA wanted to try and figure out how much “safer” that lower dose of Zorvolex might be. But since “large numbers of patients” would be needed to do a real study, it used a survey method popular in marketing called a “meta-regression” technique.
After crunching “associated P” values with “event risk ratios” and “assessment of linearity,” here’s what it came up with:
The risk of a “major cardiovascular” event is 7 percent less in patients taking that lower dose of Zorvolex!
But since the bigger dose can up your heart risk by 40 percent, even if we shave off some of the danger with that FDA computation, we’re still talking about an increased risk of heart attack and stroke of about 33 percent.
Of course we won’t know the “real world” numbers until Zorvolex starts flying off of Rx pads.
And by then it will be too late to do our regression.
Sources:
“FDA okays submicron diclofenac (Zorvolex) for osteoarthritis” Megan Brooks, August 25, 2014, Medscape, medsape.com
“World’s most popular painkiller raises heart attack risk” Richard Knox, NPR shots, npr.org
