CYMBALTA, SAVELLA AND LYRICA. THE TERRIBLE TRIO

I've always said....

it's not what they tell you....

it's what they don't tell you.

I'm as guilty as the next person. When a doctor prescribes a medicine I usually take it, however, there are a few of them that I haven't. Cymbalta and Savella were two of them. I know myself and I know that if the side effects are icky.....well, I'll quit. The problem is that we've become anesthetized to prescription medication. Again, I'm as guilty as the next person. We need to remember some of these medications are POWERFUL.

So I started looking.

I've included the sources at the bottom of this post. I was pretty amazed at what I'd found. What amazed me the most is that the FDA seemed to chide Eli Lilly (the maker of Cymbalta) about the fact that they had not designed a safe protocol for the discontinuation of the medication. They also don't tell the doctors how severe the symptoms of that discontinuation can be. 

Now, the class action lawsuits are coming out.

What? You mean you didn’t read the fine print?

Ok…we’ll settle. My bad.

You can't quit either drug cold turkey, hence my reason for not taking them. The problem as far as Cymbalta goes is that it only comes in three dosages; 20mg, 30mg and 60 mg. Plus, it is a capsule so you can't cut it in half. You are advised against opening the capsule so how do you know that you supposed to wean off slowly? Who would think to do that?

I am not coming against anyone who chooses to take Cymbalta or Savella. These medications are approved for Fibromyalgia and for anyone who has a depressive disorder. All I am saying is that people should be aware of side effects and what happens if you stop taking it. Stopping doesn't necessarily mean after weeks or months either. It can be after one dose but the longer you take it the worse the symptoms could be. 

What are the symptoms of withdrawal?

Actually it's called Cymbalta Discontinuation Syndrome.

Brain zaps that feel like an electric shock, suicidal thoughts, nausea and vomiting, headache, nightmares, diarrhea, excessive sweating, involuntary laughing or crying, tinnitus (ringing in the ears), extreme mood swings, paranoia, confusion, limb pain, fatigue, insomnia, anxiety, agitation, hypomania and seizures.

Discontinuation can be severe and extend for weeks and even months.

With Savella, there were adverse reactions during the clinical trials.

Again, I'm not coming against anyone who chooses to use these medications. Your doctor thought their use would be in your best interest. I just think all the information should be on the table. Some people may have no trouble with discontinuing these medications....others may be blindsided.

In the sources below, I also added all the information on Lyrica. Commercials make everyone think that you can take a pill and everything will work out and you'll be happy. Just for the record: I hate that commercial. I'm not one of those people that are suspicious of doctors and conventional medicine. Medications are necessary but just have all the information so you can make an informed choice.

After all....

If Eli Lilly won't tell you.......

The FDA will.......

In some archived obscure document......

Somewhere........

But I found it.

The sad part is?

The only one who will win will be the attorneys.

Sources: 

http://www.fda.gov/downloads/Advisor.../UCM172866.pdf


http://medlibrary.org/lib/rx/meds/savella-7/

                        http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf
           

TONMYA AND FIBROMYALGIA....MY OPINION

It's been awhile.

But now, it has a name.

Tonmya.

A year or so ago I got approached by a woman named Laura Colontrelle-Radocaj of Dian Griesel, Int'l. She asked if I'd be open speaking with Dr. Lederman who is the CEO of Tonix Pharmaceuticals. I was aware of the clinical trial of TNX102 (Tonmya) that was taking place  so I was thrilled that I had been given the opportunity.

I really believe there are subgroups of Fibromyalgia. I also think that is why Lyrica, Savella and Cymbalta (which are all FDA approved treatment for Fibromyalgia) don't work for everyone. For me, Lyrica was worse than the Fibromyalgia. I gained weight, which is death for me, and my thoughts went to a very dark place. I can't take it. There aren't a lot medications out there that are approved so something new on the horizon was good news. 

In a nutshell Tonix Pharmaceuticals is using cyclobenzaprine in new doses and formulations for treatment of Fibromyalgia and Post-Traumatic-Stress Disorder (PTSD) which are chronic central nervous system disorders. At first I wondered why Fibromyalgia and PTSD? To me, they were on opposite ends of the spectrum until Dr. Lederman gently reminded me how many cases of Fibromyalgia start with trauma. 

Mine included.

Cyclobenzaprine (Flexeril) is an FDA approved drug that treats the muscle spasms that is associated with musculoskeletal conditions. Pain managers use it quite frequently but it's difficult to take because it makes you groggy and sleepy the next day. Well, it seems that it takes two hours  to get into the bloodstream so if you take it before you go to bed it won't take effect for two hours. No wonder people are groggy in the morning! It's been prescribed off label as a sleep aid. What I didn't know is that there isn't any benefit with this drug after two to three weeks. Actually, what is said was "the evidence of effectiveness for prolonged use is not available," and everything I've read says that this drug should not be used long term.

So why is this different? 

Flexeril is still Flexeril.

Blech.

The BESTFIT protocol (BEdtime, Sublingual, TNX102SL, as Fibromyalgia Intervention Therapy.) uses a very low dose cyclobenzaprine. The great part of using it sublingually is that it enters and leaves the bloodstream quickly. It's 2.8 mg of cyclobenzaprine in this formulation. Tonmya is currently being evaluated in the 500 person AFFIRM trial for fibromyalgia. Patients have to report a reduction in pain from the baseline after 12 weeks. It is also being evaluated for safety as well as the effectiveness of the drug. 

So far approximately 42% of the patients experienced some kind of tongue or sublingual numbness. More studies will need to be done to evaluate long term effectiveness. Also they need to study if it will interact with any of the medications currently approved for Fibromyalgia. 

This isn't some ripoff company trying to float and old drug into a new "big fix" for Fibromyalgia. This doctor had a thriving practice and then committed what he said was, "professional suicide" by going into research on a central nervous system problem like Fibromyalgia. In his opinion, non restorative sleep changes the central pain pathways and if part of that can be fixed then patients should see a reduction in pain. 

We really do need the sleep. I don't know about anyone else but it's not very often that I get refreshing sleep and I can tell a big difference on the rare occasion that I do. Another thing I found interesting was alpha wave intrusion. The new term for alpha waves is cyclic alternating pattern (CAP), type A2 and type A3. It seems that we all have alpha waves but with Fibromyalgia we have too many alpha waves and they are too frequent. This is what interrupts our sleep. 

Yes, it's Flexeril.

But, it's not the same old dosage.....

and it's used in another formulation.

I think it should be given a chance to prove itself.

Let's not jump on the bandwagon and trash it until we know.

Just sayin'..................

It could be an important piece of the puzzle.