Monday, February 8, 2016

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
           


Thursday, February 4, 2016

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.




Thursday, January 21, 2016

BRAIN STIMULATION? NOT SO FAST.....









Sorry in advance.
This is simply shocking!


I wrote about this protocol before and in my typical tongue-in-cheek response I conjured up visions of Frankenstein and melting brains. This actually has been researched for centuries and there is real validation. For me? Call me old fashioned but I really believe there are things you shouldn't mess with and randomly shocking your brain is one of them. I know there are times for this protocol; actually they call it brain stimulation, and it can be used for major depression and seizure therapy. 

How would you like to be in that clinical trial?

Just imagine......you can stimulate your brain and have no pain. Whoa.....I should be in advertising.....stimulate your brain and have no pain. What a campaign.....there I go again.... it just never ends......anyway......

It's actually called High Definition transcranial Direct Current Stimulation or HD-tDCS. You put a few electrodes on your scalp and voila!  A few electric shocks later.....your brain releases opioid like painkillers. 

Sounds simple......

Wait...it's a 20 minutes session and it said it reduces the pain perception and it is safe using established safety protocols. Hmmmm.....I may be one of those people that are sensitive to wording. Must be from years of reading the fine print in contracts. 

There can be some side effects. A phosphene (a brief flash of light) at the start of stimulation, headache, dizziness and nausea. Ok, I'm gone at the mere mention of nausea. The one to two milliamps that are used isn't enough to make neurons start firing but the therapeutic value hasn't totally been established either. Granted the dose of electricity is very small compared to the doses used for clinical depression or seizures.  Studies have indicated that it is safe for a single use stimulation but results aren't in for long term stimulation. 

My problem with all of this is people get on the bandwagon and some person will figure out a way to have a DIY (do it yourself) way to assemble this and start opening clinics. Once that happens all legitimate research is tainted. It will absolutely fall under the category "that some is good, more is better and too much is just enough." Laboratories and universities have protocols in order and once you get outside of that arena all those safety protocols go out the window. 

I just want to know is how they figured all this out. 

How many brains did they have to melt?

Anyway.....the kicker?

The researchers don't know why this works. 

That sentence speaks for itself.

Again, with proper safety protocols...........





Friday, January 1, 2016

IT'S 2016 ALREADY?










This year has gone by so fast.
I've turned around and it's gone.
But hey.
I can't believe how fast life has gone.


I look back at all the resolutions I've tried to keep. The operative word is "tried." Looking back at it, I don't think I even tried to keep them. I know it sounds good but it just doesn't happen. I think I had it right when I said, "I'm the idea man. Follow up isn't my strong suit."

So what do I do?
I'm going to list the "resolutions" that I think everyone should adopt. 
If you can't tell the last sentence was dripping with sarcasm.

A few years ago I wrote that I resolved to be more accepting of me. I knew that I'd have bad days and good days but this is a chronic illness that has no cure. Ok....I get that. Time took care of part of that. Accepting of me? Has or will that ever happen? Probably not. I'm not very accepting when the voodoo pain hits. I'm not real accepting when the pain drags out for days on end. I'm not real accepting when I see commercials for the lousy drugs that haven't done much for fibromyalgia pain but have side effects like weight gain. For me, that is a side effect that negates any benefit whatsoever. So am I accepting? Not when I look in a mirror....yeah, I really do miss my neck.

I know....that's not a fibro thing. That's an age thing.
Golden years my fanny.........

The one that really makes me laugh is the resolution that I would check my attitude at the door when the pain gets overwhelming. Oh yeah.....that WILL NEVER happen. What was I thinking??? Attitude in the toilet is the only outlet I have when the pain doesn't stop. If I didn't have sarcasm I wouldn't know what to do! Has anyone EVER been sweet and nice when pain is stabbing at your body like the little voodoo doll it's named after? Me either.

Then I always resolve to be kinder to my body. You know...if you push you will pay. Well, I always push because I never know what the day will bring. If I didn't push I wouldn't do anything. So I guess I will have to learn to pay.

The one thing I can do is remember that it could be a whole lot worse. I know that doesn't mean much to people who feel like they're at the end of their rope. It's hard to see the light at the end of the tunnel when you're really deep in that tunnel. I am not trying to minimize what chronic pain can do. It can bring a truly strong spirit down to their knees. What I'm trying to say is to hold on with both hands and know that it will get better. Pain does change you but we need to stay strong and fight those changes.

What I've realized is that I never really appreciated all the good days before Fibromyalgia became a constant in my life. Maybe that's why I push on my good days. I do appreciate them and since they are few and far between I tend to make the most of them. It's interesting that people think we have a low tolerance for pain. Nothing could be farther from the truth. I can tolerate pain and I tolerate it on a daily basis. The levels make all the difference but the pain is never truly gone. Most of the people I've talked to feel the same way. We're not wimps. So it comes down to the difference between pain tolerance and pain thresholds. I have a very low pain threshold but my tolerance is very high. Pain tolerance is about the levels of pain that a person can take before breaking down physically or emotionally. Pain threshold is the point that the stimulus is perceived as pain. 

So, am I making resolutions this year?

No.

I never keep them anyway. 

It's too bad I can't write Dear Abby.

Then there would be more advice....

I could ignore.

I wish for a happy, healthy and prosperous New Year...

for you all.

Happy 2016!

Rosemary











Wednesday, December 30, 2015

I JUST LOVE THE HOLIDAYS











It's that time of year.
Holidays and parties.
And you are just exhausted.
More than exhausted.
Trashed.


I read somewhere that it's a good idea when you have a chronic illness to lower your standards for holiday shopping and baking. Lower my standards? How much lower can they go before I just put the covers over my head? It's bad enough that I feel pain on a daily basis, I really don't want to inflict anyone else with that on the holidays.

Then again, I don't think anyone holds the standard that I hold to myself. 

When my daughter was little we had to run from home to home to celebrate. By the time the year was over I was glad that it would be a whole year before I had to do THAT again. Then as time went on and pain entered my life I began to resent it even more. I had to stop and remember, that for me, the reason of the season was not rushing around for the perfect gift and baking until I dropped. I had to remember that I had the perfect gift and I had a wonderful family that it was a joy to be around. 

So, how do I get through the holidays?

All I can say is thank goodness for Amazon. Well, I'm going to expand that to the whole internet. What was it like before? It's hard to remember life before one-click buying. I just don't have it in me to brave the crowds anymore.  What would I want for myself and others that have illness as a part of their lives?  I would want a magic wand to conjure up a cure for myself and others.

So, now the craziness of Christmas is over and in just a few days it's the New Year. I've never liked going out New Years Eve. It's just not something I like to do. We usually go to dinner early and we're home before nine. Let everyone else party in the new year. I will watch the ball drop from my nice warm bed.

I really need to start thinking about my resolutions....

That I never keep........

But, I hope everyone had a wonderful holiday.

Now, we're on to 2016......

Oh my gosh.........

2016???

Wow........

Where did this year go???