Dangerous RA drug on fast track to approval

When it comes to drugs for rheumatoid arthritis, it looks like there’s no risk the FDA considers too big for you to take.

Life-threatening infections, tuberculosis, liver damage, cancer — it’s all acceptable, expected, and part and parcel of the RA drug package.

Then, there are the especially scary RA meds known as JAK inhibitors.

They work by blocking a process inside cells that causes inflammation. And while that may sound innocent enough, these meds can cause all those side effects… and more.

In fact, it looked like even the FDA thought the newest JAK med coming down the pike for RA was too risky — and actually refused to approve it!

But in a sudden U-turn, this new drug, called Olumiant, is now on the fast track to landing in your doctor’s office.

And before you start seeing ads on television for it with fields of flowers, blue skies, and puppies, there are some very important facts about Olumiant you need to hear first.

Too big a gamble

Experts have called the FDA’s sudden change of heart on Olumiant a “stunning about-face.”

Back in April, Eli Lilly was confidently waiting for the billion-dollar A-OK to come from the FDA. Instead, it received a letter from the agency saying, in effect, no dice.

Along with all the known risks that come along with this med, “thromboembolic events” (a.k.a. potentially deadly blood clots) caught the FDA’s eye. And it asked for a lot more data, especially more safety studies.

But that was then. Now, the FDA has actually “invited” the pharma giant to send in another “pitch” for Olumiant — additional studies not required.

That means this med is practically guaranteed to be approved, and quickly. And if you’re dealing with the pain, swelling, and stiffness of RA, you might be tempted to give this new drug a try, especially when all the hype starts hitting the fan.

Before you put your life on the line for some relief, however, there’s more you should know.

First, like the other RA JAK drug on the market, which is called Xeljanz, this new one can disable your most important form of protection — your immune system. That can leave you wide open for opportunistic and possibly deadly infections from bacteria, fungi, or viruses — specifically throat, nose, stomach, and urinary tract infections.

In fact, before anyone starts up on one of these meds they have to be carefully screened for TB.

Even shingles can hit 1 out of 10 people taking the drug.

In addition, this med can:

• trigger a low white blood cell count, an indication of compromised immunity
• increase an enzyme in your blood called CK, which is released when there’s been an injury to muscle tissue, your heart, or your brain, and
• elevate triglycerides, a type of fat in the blood that can lead to high cholesterol

But all too often, doctors will brush aside these horrific side effects. They’d like you to think that they would never, ever happen to you.

It would be wonderful if that were true. But as too many RA patients have discovered, that’s simply not the case.

If you or a loved one suffers from this debilitating condition, I’m sure you’ve heard the drill many times — how we don’t fully understand this autoimmune disease, we don’t have a cure, and you’ll just have to try these drugs and hope for the best.

But guess what? That’s not exactly true either!

While the approaches below may not give you the immediate relief risky meds can offer, giving them a chance means you at least won’t be waking up every morning worried about blood clots, TB, cancer, or a failing liver!

For example:

• Eat less red meat and add more fish, nuts, fruits, and veggies to your diet along with lots of extra virgin olive oil.
• Try acupuncture for relief from pain and inflammation.
• While it may be the last thing you feel like doing, exercising, and especially swimming, has been found to significantly improve RA symptoms.

And last year we told you about some amazing results RA patients achieved just by taking a high-quality probiotic supplement for only two months. They were able to see dramatic improvement in practically every symptom measured — no drugs required!

“In stunning about-face, FDA invites Eli Lilly to quickly refile blockbuster hopeful baricitinib” John Carroll, August 30, 2017, Endpoints News, endpts.com