Why was this RA med declared safe here, but not in the EU?

The drug so dangerous, it’s banned in Europe — but still OK with the FDA

What do they know in Europe that we don’t in the U.S.?

For one thing, European regulators know that Xeljanz is just too dangerous a drug to approve for people over there to take.

Here in the U.S., however, the FDA allowed this killer to hit pharmacy shelves almost 2 years ago. Guess that Pfizer doesn’t have the same “connections” in the European Medicines Agency that it does with our FDA.

But while Pfizer is running nonstop ads for this RA drug (you know, “arms were made for hugging, hand for holding), those “post marketing” trials are coming in.

And they don’t look good.

Of course, you would expect that any drug trial sponsored by industry will have positive results. So when they come out badly, just imagine how risky that pill must be!

And as the evidence mounts against this horribly dangerous drug, don’t expect the FDA to do anything more than just slip it in the big manila folder already stamped APPROVED.

Right out of the gate Xeljanz came with a black box warning.

It’s one of those new “biologic” drugs for RA, and it’s a horror show that comes complete with warnings about things like “serious infections” that can cause death, tuberculosis and “other opportunistic infections.”

The label also warns about lymphomas and other cancers that have been reported in people taking the drug.

When Pfizer submitted it for approval to the EU version of the FDA, called CHMP, it got a big thumbs down, meaning doctors there are not allowed to prescribe it. CHMP said that there were “unresolved concerns” about serious infections, cancers and liver damage.

And then there was that “little” problem about Xeljanz causing holes in your intestines — especially if you have diverticulitis.

But Pfizer, sure that this was some kind of mistake, asked CHMP to take another look.

It did. And Pfizer was turned down a second time. The risks of taking the drug didn’t “outweigh the benefits,” it said.

Finally, the results of one of Pfizer’s “real world” trials on Xeljanz came in. Those are the studies that take place after a drug is approved and millions of us (who don’t live in Europe) are taking it.

What it found was that some patients taking Xeljanz had increased levels of creatinine. That means your kidneys aren’t working well.

And if you already have less than perfect kidneys, well, that’s definitely a side effect you can’t risk.

But it looks like some docs here, though, aren’t taking these warnings very seriously.

One, Dr. Jeffrey Curtis, who specializes in RA drugs had this to say: “It’s one of those things that worries us in a somewhat vague way.”

Well Dr. Curtis, maybe if it were your kidneys we were talking about your “worries” wouldn’t be so “vague”!

But with a drug like Xeljanz, we really don’t need to hear more bad news about it.

Even before it was approved by the FDA, four RA patients died in one of the early trials Pfizer did on this drug. And several of those deaths were from heart failure. That, experts say, makes sense because of how the drug effects cholesterol levels.

Some of the earliest data on Xeljanz showed that it can raise bad cholesterol and lower good cholesterol, as well as causing anemia, suppressing white blood cells and damaging the liver.

But why wait for more bad news about Xeljanz? I think we know enough about this drug already to just say NO to it — just as they have already done in Europe.

Sources:
“Minor changes in kidney function with RA drug” Nancy Walsh, July 29, 2014, MedPage Today, medpagetoday.com

“EU rejection + patient death = FDA approval of another dangerous RA drug” Alliance for Natural Health” anh-usa.org