FDA issues warning about fatal reactions to IBS med
You can’t watch TV for more than ten minutes these days without seeing that commercial for the IBS drug Viberzi featuring the red-headed girl in the beige jumpsuit.
She even has a name — Irritabelle. No, I’m not kidding!
Whether you find these ads to be amusing, or downright annoying, there’s something you need to know about Viberzi that Irritabelle won’t be telling you.
Not only has the drug logged well over a hundred reports of serious pancreatitis “or death” with the FDA, but the agency has just issued a warning about who should never take Viberzi.
And that turns out to be hundreds of thousands of Americans.
But what if the key to managing this painful and disruptive condition doesn’t come from a pill bottle after all, but from a bottle of inexpensive vitamins instead?
Those Viberzi ads have already been shown close to 10,000 times. And there’s even a long version on the drug’s webpage with Irritabelle attending an “intervention” with an IBS sufferer, her friends and boss.
The advertising “Mad Men” who came up with the idea said that the point was to do something “fresh and memorable.”
Well, here’s something very fresh and also quite memorable about this drug:
At the end of last week, the FDA issued a “safety warning” for Viberzi. It finally revealed that the med is causing severe — sometimes deadly — attacks of pancreatitis and an incredibly painful condition called “sphincter of Oddi spasm.”
It also warned that anyone who has had their gallbladder removed needs to “stop taking Viberzi right away.”
Considering that gallbladder removal surgery is one of the most common operations out there, with hundreds of thousands done every year, we’re talking about a whole lot of people here.
But even though the FDA just got around to warning us about this, it appears that the agency has been sitting on its hands where this risk is concerned for some time now. On its “potential signals of serious risks” chart that came out last year, it has Viberzi marked as waiting for the FDA to evaluate the “need for regulatory action.”
And on its current warning, it says that pancreatitis (an inflammation of the pancreas that causes pain, nausea and vomiting and can lead to life-threatening complications) has happened after just one or two doses of Viberzi.
Two patients who died after taking the drug were hospitalized, but passed away despite emergency care. One died within three days of taking the very first dose.
The just-out safety announcement also tells doctors that for patients with IBS and diarrhea (what Viberzi was approved to treat) who have had their gallbladders removed, there are options.
The FDA recommends OTC meds such as Pepto-Bismol, Imodium and Gas-X.
Seriously? Imagine reading after losing a loved one from taking this med that the FDA now says they could have used Pepto.
But there’s another option as well. And it doesn’t involve taking any drugs — OTC or otherwise.
Not too long ago UK researchers discovered that simply taking a high-dose vitamin D3 supplement every day (up to 10,000 IUs, which can also be achieved by exposing your skin to a short amount of sunlight in the summer) was able to give IBS sufferers big-time relief.
The researchers also tested blood levels on IBS patients, finding that over 80 percent were deficient in vitamin D. Could that be a missing link in treating this disease?
Irritabelle, according to the ad agency, is meant to be annoying, just like a “friend who’s outstayed her welcome.” But perhaps what’s been around too long are dangerous drugs like Viberzi.
Especially if the secret to really treating IBS is simply a supplement or a sunny day.
“FDA: Avoid IBS drug Viberzi in patients with no gallbladder” Megan Brooks, March 15, 2017, Medscape, medscape.com
