The risk that may come with a new colitis med even has the FDA worried

Warning: This new drug could open the door to a rare and fatal brain disease

Dear Reader,

It was only December when the FDA announced it was very alarmed about the dangers of an experimental new drug. So much so that it wondered if its benefits could possibly outweigh the risks.

It considered restricting the use of this drug. There was even talk about a black box warning.

But by last month, all those concerns magically vanished. The FDA suddenly and unexpectedly approved this risky treatment for ulcerative colitis and Crohn’s disease.

The big worry is that it works just like another Rx. And that drug has been known to trigger a rare virus that attacks the brain.

But the FDA put it on the market anyway, even while admitting there is still “uncertainty” about the risk of this deadly brain infection.

So if you suffer from either of those diseases, your doctor may want to tell you about a brand new drug to treat them. But here are some things you should know first. Things that he may not even know.

The FDA’s buddies at Takeda Pharmaceuticals must have been high-fiving each other last month.

The company’s experimental new drug Entyvio had just gotten the fast-track approval it was hoping for.

That came despite trial data that showed the drug didn’t succeed in putting patients in remission after 6 weeks. And despite the risk of “liver injury that may lead to death” or require a liver transplant, as well as allergic reactions and infections.

And then there’s PML.

That’s short for progressive multifocal leukoencephlopathy. And it sounds like something out of a horror movie.

It’s a rare and usually fatal disease that slowly but surely destroys the brain’s protective nerve coverings.

Which is why another drug called Tysabri, one used to treat multiple sclerosis, was taken off the market in 2005. The FDA put all trials of that drug on hold when several patients came down with PML.

When it allowed Tysabri back on the market just a year later, it put all sorts of precautions in place. Things like required MRI scans of the brain, enrollment in a special safety program, and careful evaluations of people taking the drug 3 times a year. Also added was a black box warning about PML.

Here’s the scary part. The FDA is alarmed that Entyvio might carry that very same PML risk. Only we won’t really know whether it does until those Entyvio prescriptions start flying off the Rx pad.

But by then it may be too late for those who are already suffering from Crohn’s or ulcerative colitis.

When the drug company conducted its trials to test Entyvio, it did so very carefully. Patients were examined before, during and after. A panel of PML experts looked for any potential cases of the brain virus. Patients had to give their “informed consent” and were educated about the risks.

But now, those precautions are history. All the FDA asks is for doctors and nurses to “monitor patients” taking this new drug. There’s no black box warning and no special safety program like there is for the MS med.

I’ve warned you in the past about the unknown risks that come with all new drugs. But with this one, it looks like we already have a good idea what those risks may be — and they’re terrifying.

Sources:
“FDA approves Entyvio to treat ulcerative colitis and Crohn’s disease” FDA press release, May 20, 2014, fda.gov

“Takeda colitis drug raises PML concern: FDA staff” Ransdell Pierson, December 5, 2013, Reuters, reuters.com

“FDA approves resumed marketing of Tysabri under a special distribution program” FDA press release, June 5, 2006, fda.gov