This newly-approved drug combo spells trouble on both ends
Yosprala. It sounds like the name of a soda or maybe a new kid’s game.
But there’s nothing funny about this new drug just approved by the FDA. In fact, there are so many things wrong with it I don’t even know where to begin.
It’s a combo pill containing two of the most troublesome, side-effect-prone meds on the market — aspirin and omeprazole (that’s Prilosec, a proton pump inhibitor or PPI).
And the craziest thing is that experts have been warning about this combo — which is supposed to protect patients on aspirin therapy from stomach damage — long before the FDA gave it the green light.
You could say there’s something not to like about Yosprala for just about everyone.
Everyone, that is, but the FDA!
If there ever was a new drug that came out of the box waving red flags, Yosprala is it.
First, of course, there’s aspirin. I’m sure you’ve seen those “Wonder Drug” ads on TV since Gilligan was trying to get off that island — but the only wonder here is how aspirin continues to be sold in gallon jugs at every convenience store.
For years now I’ve been telling you about the deadly risks of a daily aspirin regime. Even the aspirin-lovers at the U.S. Preventive Services Task Force recently admitted that if you’re under 50 or over 59, there’s no benefit to taking a daily aspirin.
And if you’re over 70, don’t even think about it. The group said that puts you at “significant risk” of a major bleed, hemorrhage or stroke.
And as far as aspirin preventing heart disease, even the FDA wouldn’t let Bayer get away with that nonsense on its bottles.
Then there’s Prilosec, one of those PPI drugs I’ve been warning you about.
PPIs come with a list of side effects as long as your arm. Things like broken bones, kidney damage, esophageal cancer, life-threatening infections and dementia.
And get this, just a few months ago I told you about some new research that found PPI meds can block and deactivate special cells that protect our blood vessels. The researchers compared it to converting these protective cells from “Teflon to something more like Velcro.”
In other words, PPIs could put you on the fast track to heart disease.
As I said, long before Yosprala was approved, the very idea of this combo was enough to start sounding the alarms.
For example:
- Research out of Denmark five years ago concluded that those taking aspirin therapy who had a first-time heart attack were at a higher risk of “adverse cardiovascular events” when they also took PPIs.
- Three years ago researchers did an extensive search of studies using this particular combo and concluded that it “remains unclear whether the benefits” of adding PPI drugs to a low-dose aspirin regime “outweigh their potential harms.”
- And, my favorite: several studies have found that PPI meds can counteract aspirin’s blood-thinning effects! One scientist called it a “drug interaction” that may have “substantial clinical impact.”
Seriously? Doesn’t the FDA even look at this research?
But even that is outdone by the drugmaker’s own safety information packet, which includes the warning that Yosprala “has not been shown” to lower your risk of GI bleeding from aspirin.
It also warns us to be on the lookout for kidney problems that “may happen at any time,” diarrhea from a C.diff infection (another side effect of PPIs), as well as one I hadn’t heard about before — a new or worsening case of lupus.
Are you kidding me? You could call this drug the worst of both worlds!
I’ve often said to steer clear of new drugs because we don’t know what the side effects might turn out to be.
But I take that back where Yosprala is concerned. We know quite enough about them already.
Sources:
“Aspirin pill that protects stomach OK’d for heart patients” Reuters, September 16, 2016, Newsmax, newsmax.com
