OPANA CHANGES FORMULATION - SAGA CONTINUES

Ahhh, Opana ER, I hardly knew ya!

For many of you chronic pain patients, especially CRPS patients, you know all too well what happens when a drug company changes their formulation on a tried and true pain medication.

1) The chronic pain patients who have been having great success on that medication, and who were NOT abusing it, suddenly find that the new version does not work as well for them;

and/or

2) The new version has some type of coating, which was the reason for the new formulation in the first place, that seems to make everyone who takes it sick to their stomach because of the stuff it is made of;

and/or

3) Because this new coating is not completely breaking down in your stomach and/or intestines before it passes through and out of your body you do not get 100% use out of the medications pain-relieving properties.

Therefore, you do not get the pain relief you were getting on the old version of the medication, your stomach develops various problems, AND your pain issue (whether it is CRPS or fibro or whatever, starts to spike.  Sometimes people forget that the Digestive System is endowed with its' own local Nervous System and when it gets riled up it can lead to all sorts of pain spikes, especially when you have a disease like CRPS. In fact, some children can get what they call CVS or cyclic vomiting syndrome and it involves migraines and the gut.


Don't think you are alone in this. It happened back in 2010 with Oxycontin when they changed that medication ( Oxycontin Re-formulation - not well received )  and now it has happened again with another very successful medication for treating chronic pain, Opana. You can read many blogs/lists/websites about patients stories on the net, here is just one I have followed 

Unfortunately the purpose behind these re-formulations was supposedly to deter abuse.

Mainly by people who were getting it from the street, they were doing everything from snorting it to breaking it down into smaller sizes, and probably a hundred other things. Some were doing it to get high, some were doing it because they needed the drug for pain relief and couldn't get it legitimately.

The makers of these drugs decided they would come up with ways to coat the medications so no one would be able to "break-down" the drug without destroying it in the process.

Well in both of these cases they severely underestimated the people they were up against and their desire for the drug, and apparently the financial demand for it. In both cases within days the internet was filled with instructions on how to break it down.

I remember going on-line after the new Opana was introduced, I wanted to see what, if any, people had to say about it. I was shocked to see the posts by people who were already sharing ways to break down the coating. Those posts were mixed in with posts from legitimate patients who were really upset because once again, their pain relief was going away, the stomach pains were back, and another short-lived attempt at pain-relief was yanked from their hands by short-sighted people.

I personally had been on Opana since the change to Oxycontin. I was one of the many, many legitimate patients who had done well on Oxycontin only to have to change to something else when the change came to Oxy. I, like many, switched to Opana. I was thrilled because it worked even better than Oxy. There aren't a lot of options when it comes to pain relief for CRPS patients; opiod agonists are one of the best. Oxy was one of the most popular, then most had to switch to Opana.

Then in March of this year Opana switched to a new formulation and bang. It happened again. Within days the abusers had figured out how to beat the system, get around the new tamper-proof and crush-proof coating, and they were back to snorting it, and doing whatever else they do to them once they are in powder form. While those of us who take them legitimately were left holding the bag, and for some people it was a very expensive bag depending on your co-pay.

So .... it is back to searching for a new source of pain relief for many of us, and looks like after spending all that money on re-tooling a successful product, Endo Pharmaceuticals will be losing quite a lot of customers. What is that old expression? If it ain't broke, don't fix it.

Some will go to another opiate, many will try the patch. Some will even try the Opana IR, or instant release version (the re-tooled opana was the ER or extended release).

For me, I went to the Fentanyl patch. I tried the new version of Opana for five weeks. All it did was put me into a very bad CRPS flare, very bad. I have been on the patch for a few weeks now and it has started to calm down my flare and I am doing better. I should be back to "my version of normal" in another week.

The good thing about the patch is that it has three levels, 25 mg, 50 mg, and 75 mg so I can even get more pain relief than I had with the Opana, PLUS I have already noticed the best thing about the patch; since there is no internal opiate being taken, I have no internal side effects that come with it! Meaning no constipation! I know that may sound a little vulgar but for those of you who have had to deal with it for years like me, even with whatever remedies you have used, it is a pain in the you know what, no pun intended.

Nor do you have the other side effects that come with taking an oral opiod, dashes of medication (where suddenly you feel a rush of the medication, it can sometimes get released that way when it is an ER), it is much steadier with the patch, and you don't feel as sleepy or dopey with the patch for some reason, even at the same level or higher of med. In addition, the medication is more effective because it is delivered directly into your bloodstream, nothing is wasted, nor do you have to wait while it is absorbed through your intestinal wall.

So I am hoping and praying that people don't find a way to abuse the patches so they don't feel the need to re-formulate them! Wish me luck.

Praying for all of you as well.

Peace to you all,

Keith

American RSDHope

Opana - new formulation - Pain and other drugs

Opana ER, manufactured by Endo Pharmaceuticals, changed in March of 2012.

Endo was allowed by the FDA to change the formulation of Opana ER.

According to Endo, ""FDA's approval of this new formulation of Opana ER is an important milestone for both the Long Acting Opioid category as well as Endo's branded pharmaceutical portfolio," said Dr. Ivan Gergel, M.D., executive vice president, R&D and chief scientific officer, Endo Pharmaceuticals. "Patient safety is our top concern and addressing appropriate use of opioids is a responsibility that we take very seriously.  We firmly believe this new formulation of Opana ER, coupled with our long-term commitment to awareness and education around appropriate use of opioids will benefit patients, physicians and payers." 

* See entire article

Also according to Endo, "The new formulation, which utilizes the proprietary INTAC™ technology owned by Grunenthal, will continue to be called Opana ER with the same dosage strengths, color and packaging and similar tablet size and shape. Also, the FDA approval means that there is no significant difference in the rate and extent of absorption of the therapeutic ingredient between this new formulation and the original formulation of Opana ER."

* See entire article

Just when we get our bodies used to one set of medications, something else changes!

Keith 

CRPS articles - new articles February 2012

We just added a few new articles to the website this week in case you wanted to check them out.

One in particular I found very interesting;

Neuron Memory Key to Taming Chronic Pain

The subheading reads;

Study Suggests Erasing Neuronal Memories May Help Control Persistent Pain

The first two paragraphs should be enough to make you want to read the entire study if you suffer from chronic pain but especially if you suffer from CRPS I think, or any type of neuropathy;

Newswise — For some, the pain is so great that they can’t even bear to have clothes touch their skin. For others, it means that every step is a deliberate and agonizing choice. Whether the pain is caused by arthritic joints, an injury to a nerve or a disease like fibromyalgia, research now suggests there are new solutions for those who suffer from chronic pain.

A team of researchers led by McGill neuroscientist Terence Coderre, who is also affiliated with the Research Institute of the McGill University Health Centre, has found the key to understanding how memories of pain are stored in the brain. More importantly, the researchers are also able to suggest how these memories can be erased, making it possible to ease chronic pain.

Let me know what you think!

We also added back in an article we used to have on the old site, from a 2009 edition of the US News and World Report, an excellent magazine if you have never read it. It is chock full of great information and very few ads. Don't let its' slim size fool you.

The reason we re-posted it was because the content is being bandied about a lot these days; the topic of addiction, dependence, and tolerance and the problem of people not understanding the differences between the three. I will also include a link to an article I wrote on the subject.

Most people Do not even understand that tolerance is part of the equation and it is an important part nor do they understand the true definition of dependence. Part of this is the fault of the media for not defining it correctly and part of the fault lies with the medical community for not correcting them I believe.

The article from US News and World Report is called "Managing Your Pain, How to Use Prescription Drugs Without Becoming Addicted"

I think that there are a great many lawmakers out there, legislators that is, and people in the media (who I doubt have ever pain in real pain or know anyone who has), who truly understand that that is possible.

In ADDICTION, DEPENDENCE, AND TOLERANCE, an article I pulled together a few years back is the following quote;

"Some medications used to treat pain can be addictive. Addiction is different from physical dependence or tolerance, however. In cases of physical dependence, withdrawal symptoms occur when a substance suddenly is stopped. Tolerance occurs when the initial dose of a substance loses its effectiveness over time. Addiction and physical dependence often occur together." People who take a class of drugs called opioids for a long period of time may develop tolerance and even physical dependence. This does not mean, however, that a person is addicted. In general, the chance of addiction is very small when narcotics are used under proper medical supervision." The article goes on to say, "Most people who take their pain medicine as directed by their doctor do not become addicted, even if they take the medicine for a long time."

There are some great facts in there backed up by a few very good articles in case you ever need to make the case to a Doctor or insurance company. I tried to pull together information from many different articles regarding addiction, dependence, and tolerance to help explain the differences between the three.

Hope this helps!

Have a great week everyone! Stay warm!

Peace, Keith

American RSDHope

Ice and CRPS or ICE and RSD

I have been asked this question so many times that I have written about it a lot. So if you have read it here or elsewhere before, feel free to skip on over it :-D

The question is, Is it bad to apply ice pack to the CRPS (or RSD) affected area? (or even nearby)

Or, Is it bad to use the hot/cold contrast therapy in the CRPS affected area?

(hot/cold contrast therapy

I would definitely suggest you read our physical therapy section of the website, especially the article on Ice and CRPS,

one section of the article on Ice and CRPS, Dr Hooshmand states the case very well when he says;

"On the other hand repetitive application of ice freezes and coagulates the myelin (fatty tissue insulating large nerve fibers) exactly like ice freezes and solidifies melted butter. As the ice freezes the large nerve fibers, causing freeze damage to the myelinated nerves, the patient develops sensory loss and pain due to permanent damage to the large sensory nerve fibers.

This aggravates the RSD by adding sensory nerve pain of non-sympathetic origin to the initial thermal sensory pain of sympathetic origin. As a result, Ice provides total anesthesia and relief of pain for several minute the same way as the hand becomes numb being exposed to snowballs in the winter. However, a few hours after the cessation of ice exposure, the pain recurs with vengeance due to reactive enlargement of blood vessels after the constriction of blood vessels due to exposure to ice. This phenomenon causes excellent relief of pain with ice treatment followed by not only aggravation of pain, but damage to the nerve fibers adding sympathetic independent pain (SIP) to the original sympathetic mediated pain (SMP)."

If you need a refresher course on SIP and SMP (IMP as it is sometimes called) check out this article.

But pay particular attention to the words I put in bold letters in the quote above. So often I hear from patients who say, "But it feels better when I apply ice or run my hands under cold, ice-cold water for a few minutes", but they have to do it more and more often as the weeks and months roll on. And then hours later the pain is worse then ever.

The reason they have to do it more often and the reason the pain is worse than ever afterwards is both the same, are both the same. That is what Dr Hooshmand is saying above. The more you do these things, the more you are breaking down the protective myelin sheath that protects the nerve. Pretty soon there is no going back, the damage is permanent and the pain is no longer SMP, or localized, but SIP, or brain centered. This is where the pain-cycle gets in that stuck position and is nearly impossible to break. It is also where it seems the disease spreads.

We hear so many sad stories of patients whose use of ice precipitated their spread of their CRPS, from the one small area to not just further up that limb but also the opposite limb. It also seems to accelerate the timing of the disease through the stages if ice is used repeatedly.

Remember also that ice, even very cold water/temperature, can cause the blood vessels to constrict and/or spasm. This is one of the four main symptoms of CRPS (spasms in muscles and/or blood vessels). It can be very, very painful for your extremities; toes, fingers, feet, hands, nose, etc.

So please, be very cautious here. If your physical therapist insists on using ice, educate them. This is your life we are talking about, you are the boss, take control, take charge!

There are other articles on the net besides the one sited above too. I just think his is the best and probably was the first!

Peace,

Keith Orsini

American RSDHope

New Book for teens with CRPS / RSD

There is a new book written by teens and for teens with CRPS / RSDS, more commonly known as complex regional pain syndrome. We wanted to pass along their information so you could check it out and let us know what you thought of it!

It is co-written by Doctor Gillian.R. Lauder and Roslyn Massey, and it was illustrated by Shona Massey. Both Roslyn and Shona Massey are high school students. Doctor Lauder is a Pediatric Anesthesiologist with over 20 years of clinical experience.

You can read more about the book as well as order it by going to their website here!

According to their website;

"The principal aim of this book is to provide well-presented clear information for teenagers who develop CRPS. It is hoped that it will be used as a tool to aid the early recognition of CRPS and implement the necessary team approach to management. Medical terms have been explained in a way that can be easily understood. In an effort to make it even more useful, the authors asked a focus group of teenagers– which included those who have been treated for CRPS – to provide their feedback.

In Complex Regional Pain Syndrome (CRPS) Explained, teenagers can follow cartoons of Harold the alpha lion, who develops CRPS, and relays his journey from diagnosis to team management and recovery. With a clearer understanding of CRPS, teenagers will be able to take part in the decisions that affect their health and body.

Complex Regional Pain Syndrome (CRPS) Explained is referenced throughout and provides a list of other relevant books. In addition, an extensive list of contacts is provided to promote access to pain management clinics worldwide. Hence, although this book is specifically designed to cater to the needs of a teenager with CRPS, it will also serve as an extremely useful educational tool for families and healthcare professionals.

Let us know what you think of it!

American RSDHope

Ketamine helpful for depression

According to a recent article, published on LiveScience,com ,

" Prozac and other treatments each improve conditions for only about 30 to 40 percent of the patient population, barely outperforming placebos; meanwhile, a single infusion of ketamine washes away the symptoms of 80 to 90 percent of patients who try it,"

That is amazing! The article is very interesting and it goes on to talk about how the Drs and researchers at Baylor, where the study is being conducted, believes the FDA may approved the drug as an antidepressant in as little as two years!

Still, much is needed to be learned as to how the drug works.

"Scientists understand how ketamine chemically affects the brain, but they don’t quite know why it alleviates depressive symptoms. According to Ken Robbins, a clinical professor of psychiatry at the University of Wisconsin-Madison, ketamine binds to portals in the brain called NMDA receptors; this prevents a chemical called glutamate from occupying the same spots. Because glutamate revs up the system and can cause cell damage, ketamine has a sedative effect by blocking it. Somehow, this causes euphoria.

"The hypotheses for why ketamine might be helping depression are in their infancy," Robbins said. Whatever the explanation, "it's a very different mechanism from that of other anti-depressants we now use. I think what we're seeing is there may be a whole other neurotransmitter system that plays a role in depression that we weren't aware of."

You can read the complete article here

The drug, which is addictive and must still be administered through an infusion, holds great promise and most of the readers here will remember has been used for years to treat CRPS. Perhaps if it is approved to treat depression it will open the door for treating CRPS patients as well, many of whom suffer from depression as a result of years of being in chronic pain.

Peace, Keith Orsini

American RSDHope

FIBROMYALGIA - NEW ARTICLE

There was a new article published recently on Fibro.

The Clinical Concept of Fibromyalgia as a Changing Paradigm in the Past 20 Years

It is a very good article and if you have fibro, which millions of us do, definitely check it out. 2-4% of the population in fact have fibromyalgia!

Quite a large number huh?

This is a huge sweeping article that encompasses all aspects of the disease, from beginning to end, so even if you don't have it you might find it an interesting read.

I found it interesting in that it said that only 5-7% of patients are male.

Figures. Not only do I get a rare disease like CRPs but then I am in that strange percentage of patients that also develop Fibromyalgia and in that even smaller percentage of fibro patients that is male. Not to mention that most CRPS patients are also female. AND my CRPs is full body, or systemic and only 7-10% of CRPS patients end up with systemic CRPS. Then add in the number of those patients who go on to develop CFIDS (chronic immune deficiency syndrome ) I am not a math genius but I would say those odds are pretty high. Maybe I should play the lottery more.

I am not complaining. Life is what it is, you play the hand you are dealt. But it would be nice not to be so tired, exhausted, and just worn out all the time. And oh yeah, not be in pain. That too.

But the patients I talk to, the fibromyalgia patients that is, the overriding symptom they complain the most about is the fatigue, more so than the pain.

Similarly with CFIDS; as they say on the CFIDS Association of America website; the overriding symptom is incapacitating fatigue; (experienced as profound exhaustion and extremely poor stamina). There are other symptoms of course; short-term memory problems, difficulty concentrating, flu-like symptoms, etc.

Another interesting section of the article is where they discuss who should be doing the diagnosing now. They make the case that there is enough information available that there is no longer the need to refer the fibro patient out to specialists, that the PCP (Primary Care Physician) has enough information at hand that in his office setting he should be able to determine whether or not you have fibromyalgia; provided you do not have a multitude of other medical conditions which could possibly overlap. That a diagnosis of fibro should be made based on inclusion not a diagnosis of exclusion. This is a big point and well made in the article.

They also point out the importance of movement, activity, to the fibro patient. Do something, anything, to keep your body active. Walk, bike, swim, volunteer, something. The worst thing you can do with this disease is nothing. Your muscles will atrophy very quickly and the fatigue and muscle pain will worsen exponentially.

So check out the article, let me know what you think!

peace, Keith

American RSDHope

www.RSDHope.org