The warning the FDA refuses to warn you about
This prescription drug will soon be as easy to buy as toothpaste.
And because of that, you might think it’s just as safe.
It’s another “Rx to OTC switch” coming your way. But it’s more like a “bait and switch.” We get baited into believing a prescription drug is now safe because it’s in a different package. And because it can be bought “off the shelf” — without a doctor’s OK.
This Big Switch has already been made by three other heartburn meds known as Proton pump inhibitors, or PPIs — Prilosec, Zegerid and Prevacid. And next comes Nexium. “The Purple Pill” will soon be joining them. Sitting next to the cherry-flavored Tums and looking just as innocent.
Only something important is missing on the package of these drugs, and will be with Nexium, too.
And it’s something you really need to know before you start popping these drugs like they can’t hurt you.
Because they can.
When your doctor writes you a prescription for a PPI, you know what comes with it. The bag is filled with pages and pages of warnings.
And for PPIs those warnings can be dire…including increased risk of hip, wrist and spine fractures!
But when that very same product goes OTC suddenly the warnings go out the window. Or rather through the loophole.
You see, the OTC version is the same drug, but it’s only available in the lower dose pill. So the FDA came up with an easy way to let Big Pharma off the hook.
And here’s what they’re counting on:
The directions say to take only one pill for no more than 14 days.
Come on…we’re all adults here.
Everyone knows – including the FDA – that folks are popping them like candy. And for much longer than two weeks!
And that’s when they start to get really dangerous.
This was one of the most outrageous examples I’ve seen of the FDA playing nice with its Big Pharma cronies.
I’m (not) warning you
Instead of deciding these Rx-to-OTC heartburn drugs could keep this warning off, the FDA should have made the pharmaceutical companies put it in big, bold letters.
So here’s what you WON’T be reading on that Prilosec, Zegerid, Prevacid, and next-up Nexium OTC package.
- Using these drugs can increase your risk of hip, wrist and spine fractures.
- The risk increases the longer you use them, with those taking them for a year or more at the greatest risk.
- Taking a higher dose, even for under a year, also increases the chance of a fracture.
- The danger also increases if you have other risk factors for broken bones and are over 50.
The FDA’s last comment about those warnings — the ones they originally said were so important — is that they didn’t need to be on the packaging because the drugs are only “intended” to be taken at the dose of one pill a day for 14 days. And that’s not to be repeated more than three times a year!
Really? Give me a break. If that’s true then why do these brands have a mega 42-pill size? And why in the world would Prevacid have a “perks program,” where you get “rewards with every purchase?”
“Pfizer gets FDA green light for Nexium OTC launch as AZ braces for competition” Carly Helfand, March 31, 2014, FiercePharma, fiercepharma.com
FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors, U.S. Food and Drug Administration, fda.gov