New Fibro Drug

Discussion in 'Fibromyalgia Main Forum' started by cathugs, May 12, 2009.

  1. cathugs

    cathugs New Member

    I went to my Rheumy today and he started me on the new drug
    SAVELLA. He had just gotten the new drug in last week.
    He gave me a 2 week starter pack. It is a tritation pack.

    I took my first one tonight. It starts out with 12.5 mg twice a day for 3 days, then 25 mg twice a day for 4 days, then 50 mg twice a day.

    If it helps he will give me a rx for it. He can even up the
    dosage if it works.

    Has any one else started on this med? I sure hope it works for me.
    That ''Devil" Lyrica nearly did me in. I know the Lyrica really
    helps a lot of people, but it wasn't for me.

    My Rheumy said that some of his patients had good results
    and some didn't with Lyrica.

    I will keep posting as I take this Savella and let you all
    know what it is doing for me.

    ((((((((((((cathugs)))))))))))))) ruth
  2. jmq

    jmq New Member

    How spooky! I just posted the same question! I did not see yours. I went to the Rheumy today too. Mine just gave me an article about it. He hasnt prescribed it yet. I too, am very curious to hear about it.

    I am already on Lyrica. I was lucky and have not had any bad side effects...other than gaining weight! It helped a great deal for about six the pain is getting severe again. It has helped me some with the fatigue.

    I hope we get some answers about the Savella...

  3. lynncats

    lynncats New Member

    wow, my rheumy mentioned this to me in Feb. said it would be available in april, but when my appt. came in April she said it was not on the market yet, but would be in June, so in June I'll see if she will put me on it. Cymbalta is not for me, and that is what she is trying now. Don't like Cymbalta at all, makes me feel like a zombie, and then at bedtime my brain won't quit, it's like I'm laying there with my eyes closed, but not asleep only thinking. Please keep us informed on the Savella, I'm soooooo curious how FM'R's will respond to it. Take care, and thanks!!

  4. cfsgeorge

    cfsgeorge New Member

    all drugs for fms do nothing but try to mask the symptoms and risk huge side-effects. However, the next fda drug for fms called xyrem(ghb) which will give you refreshing sleep and allow gh release to repair your body and mind. This is not a masking drug, but real treatment or cure. i do believe it's going to be the miracle drug for both cfs and fms. look it up.
  5. pearls

    pearls New Member

    I take Lyrica and realize there are risks. But it has made a
    huge difference in my life. My pain is better by maybe 75 to
    80 percent, and I also sleep much better - through the night,
    if I am careful with my sleep hygiene.

    You say these drugs only mask our symptoms. But how do
    you mask the fact that you are sleeping better? My body and
    mind must be repaired better than before since I feel better
    during the day and have more energy. Where did all that come
    from ? Besides, if Lyrica masks my pain, I'm all for it. Until the
    day somebody can help me get to the root of the problem, I'll
    take my Lyrica, thank you.

    -Pearl S.
  6. cfsgeorge

    cfsgeorge New Member

    You are "feeling better", but are you really "getting better"? Many take strong painkillers to feel better, but are they getting better? Do Opiates cure your CFS/FMS? Do A/D's cure?

    I have CFS with no pain, so i concentrate on the symptom of insomnia mainly. I have been sleeping 8-10hours for over 6months now with meds, supplements, and proper hygiene, but i'm still not getting better. I use amphetamines sparingly to help me with the OI which makes me feel a bit better, but in no way are amphetamines gonna make my CFS better.

    There are many treatments, drugs, supplements that i can take to make me "feel better", but none has got me any better. why? No one is doing anything to target the root problem which is unknown. No way you can get better from cancer w/o knowing to target the cancerous cells. No way you can get better from AIDS w/o targeting HIV. No way you can get better from diabetes w/o insulin. All these chronic diseases have pain, insomnia, nausea, fatigue like CFS/FMS, but they do not rely on masking drugs like pain killers and A/D's to treat the root cause of their disease. Without these wonderful and specific treatments-chemotherapy, anti-virals against HIV, or insulin, they may "feel well", but they would never "be well".
  7. mujuer

    mujuer New Member

    I tried it several years ago after a sleep study. It made me very sick. You have to wake up in the middle of the night, providing you do go to sleep and take a second dose of it. It really was a wild ride on that stuff. I tried it for a week and then quit. I have tried other sleep aids and guess what? I get great sleep, but thats not the answer either. I still have mega flares and fatigue.

    cfsgeorge-I feel your pain. I don't know how long you have been a sufferer but as we progress in years with our dd and have tried everything, we get very frustrated. Dr.s only can treat our symptoms. I am trying a new Dr. out of state who has fibro himself and he has not yet found a cure but he has done his own research and came up with some underlying causes of cfs and fibro.

    We all get frustrated at times, especially when we try different things and they don't work. Some things work for some and not others. I just recently discovered that there are children, yes children who are fibro suffers. They put them on all of the same drugs that we all take. Can you imagine? That is just not acceptable to me. The research needs to be in the cause and not just a symptom reliever.

    I do support all of us on this board for whatever dd they have and for whatever they try to just get thru the days and nights. P
  8. cfsgeorge

    cfsgeorge New Member

    I'm sorry it did not work for you. It seems to have worked well for many FM patients especially since FM is seen as a sleep disorder by many. I know everyone will have a different reaction to drugs especially when we are all so sick.

    When i was healthy, I did use GHB for a very short time about 15 years ago when it was legal and sold OTC as a bodybuilding supplement. I was an avid gym rat and a top personal trainer at one time. GHB does work wonderfully for sleep and it does help your body release GH which has wonderful health benefits esp for bodybuilders wanting to shed fat. You should also know that GHB is a "natural" neurotransmitter produced by our own bodies so it's non-toxic. Everyone needs GHB to realease Growth Hormone(GH) to "repair" all parts of our body. I don't know why it didn't work for you as feedbacks has been very positive at multiple boards. Maybe the initial diziness made you motion sick? i encourage you to do a search for xyrem and read the feedbacks.

    I am convinced at this time that it can help me. I do believe xyrem is treating the cause and not just a symptom reliever. And yes, i've tried multiple treatments, drugs, and supplements to no avail and saddened even worsened me afterwards. xyrem will be different. i'm really out of options for a cure to CFS other than Xyrem and Ampligen.

    I've heard of children with CFS, but FM now as well? I thought these diseases was mainly affecting adults 30-50yo? maybe children can't voice their concerns as well as adults. either way, children with fibro and cfs would be really sad to see.

    Can you list your current sleep meds that give you great sleep? i take a ton of both natural and prescription sleep meds to get me 8-10 hours, but i still wake up horribly "unrefreshed".
    Thanks and good luck to you with your new doc.

  9. bunnyrabs

    bunnyrabs New Member

    I am curious cfsgeorge,

    You are the first person I've run across that took "xyrem" when it was still OTC. Do you think it will have different effects for/on you now that you are ill versus when you were healthy? Maybe MF/CFS alters our ability to tolerate some medications versus before when we were healthy. Most narcolepsy patients tolerate it pretty well but some don't and can't take it.

    I too believe the only way a sleep medicine can work correctly is to restore normal sleep architecture, not just keep someone asleep especially if it isn't the right kind and/or right amount of sleep. If you have alpha intrusions every time your brain tries to enter stage 3-4 sleep (like I do), the only way to correct it is to induce these stages by force, and the only medicine that is proven to do that is GHB/Xyrem. None of the other sleep meds I've tried have been able to correct this kind of sleep disorder. That being said, for many, ANY kind of sleep is better than no sleep.

    I considered trying Xyrem a while ago but my insurance wouldn't cover it at the time. My new insurance might. I wish I had known about it when you could by it in a vitamin store.

    Incidentally, I was a teenager when I developed FM, so it does occur.
    [This Message was Edited on 05/15/2009]
  10. AuntTammie

    AuntTammie New Member

    While I totally understand the frustrations of not being able to sleep and the awful effects of that on ME/CFS and FM, and I also understand how Xyrem works, it is not something to just lightly try. There are some pretty good (bad?) reasons it is one of the date rape drugs, and while people using it for that might use too much and/or in combo with other substances, the results from taking it alone are not minor (esp if someone also has something like sleep apnea and is unaware of it)

    the following is from the xyrem manufacturer's site:

    Important Safety Information

    1. XYREM® is a controlled substance. Controlled substances are medicines that, if abused, may lead to varying degrees of physical or psychological dependence. XYREM is a Schedule III drug — which means that it has a moderate dependence liability. If you sell, distribute, or give your XYREM to anyone else or use it for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines.

    2. It is very important to keep XYREM out of reach of children and pets.

    3. XYREM can cause serious side effects including trouble breathing while asleep, confusion, abnormal thinking, depression and loss of consciousness. Tell your doctor if you have any of these problems while taking XYREM.


    Central Nervous System Depressant with Abuse Potential. Should not be used with alcohol or other CNS depressants. Sodium oxybate is a form of GHB, a known drug of abuse. Abuse has been associated with some important central nervous system (CNS) adverse events (including death). Even at recommended doses, use has been associated with confusion, depression, and other neuropsychiatric events. Reports of respiratory depression occurred in clinical trials. Almost all of the patients who received sodium oxybate during clinical trials were receiving CNS stimulants.

    Important CNS adverse events associated with abuse of GHB include seizure, respiratory depression and profound decreases in level of consciousness, with instances of coma and death. For events that occurred outside of clinical trials, in people taking GHB for recreational purposes, the circumstances surrounding the events are often unclear (e.g., dose of GHB taken, the nature and amount of alcohol or any concomitant drugs).

    XYREM is available through the XYREM Success Program®, using a centralized pharmacy 1-866-XYREM88® (1-866-997-3688). The Success Program provides educational materials to the prescriber and the patient explaining the risks and proper use of sodium oxybate, and the required prescription form. Once it is documented that the patient has read and/or understood the materials, the drug will be shipped to the patient. The XYREM Success Program also recommends patient follow-up every 3 months. Physicians are expected to report all serious adverse events to the manufacturer.

    Common Side Effects[1]

    The most common side effects reported with XYREM® are:

    * Nausea
    * Dizziness
    * Headache
    * Vomiting
    * Sleepiness
    * Bed-wetting

    An increase in side effects may occur with higher doses.

    If you experience the following side effects while using XYREM, you should promptly call your doctor:

    * Confusion
    * Vomiting
    * Sleepwalking
    * Breathing problems
    * Depression
    * Abnormal thinking

    These are not the only possible side effects with XYREM. If you are concerned about any other possible side effects with XYREM, please consult your doctor.

    # In XYREM clinical trials, approximately 80% of patients maintained concomitant stimulant use
    # Daytime sleepiness significantly decreased, as assessed by the Epworth Sleepiness Scale (ESS)[1][2]

    my note - according to the charts included, this "significant" improvement was only 1 point on the ESS when using the lower does of point on a self-report subjective scale is not significant at was a little better with a higher does, but as the doses increase, so do the adverse reactions

    also, they fail to mention the complete loss of memory that occurs with this drug...that is one of the reasons that rapists love it so much.....if one is taking this and then going to sleep, that memory loss is obviously not such a big deal, but it is very possible to take this and not go to sleep rt away - if that occurs, the person taking it is highly suggestible and still able to function and will have no memory of what he/she did during that time.....for most of those who might take it for ME/CFS or FM, this is not going to be an issue, bc they will be taking it at home and going rt to bed....I only mention it bc it could be a problem if taken any other way (for instance, I sometimes take half of a flexeril if I have been sleeping very poorly for a lot of does not hit me quickly, though, so I have taken it when with family or with friends, as much as a few hours before I will actually be going to bed....obviously I trust them, but if someone were to do something similar with xyrem and not be with some they completely trust, it could be bad).....I realize that this scenario is highly unlikely - I just want people to be aware, so that if they do wind up taking it, they are prepared
  11. bunnyrabs

    bunnyrabs New Member

    Thanks for the response AuntTammie. I read all the manufacturer's literature when I researched Xyrem before, which is why I prefer real-world user experience and input. Have you read the manufacturer labeling for some of the other drugs we fibro patients use? I don't mean the pamphlet that accompanies meds from the pharmacy, I mean the information intended for doctors and pharmacists. It's every bit as scary. Makes you not want to ingest anything other than food.

    The precautions you note at the end of your post can also be said of alcohol, which is the most popular date rape drug there is, and readily available. Ambien, which many of us use was in the news when some who were taking it found themselves "driving while on Ambien" in the middle of the night, with no knowledge of doing it. I think all sleep meds alter our memory to various degrees, on top of the brain fog we already have. That is why I was asking cfsgeorge about his experience with meds before he got sick.

    From my research, the narcolepsy patients have largely discredited the exaggerated fears of this drug, except the part about how it changed many of their lives in unimaginable ways. Some of them have been using it for 20 years, and some of them use it for fibro as well as their narcolepsy.

    [This Message was Edited on 05/15/2009]
  12. AuntTammie

    AuntTammie New Member

    I have read the info for the Drs and pharmacists on EVERY drug I have ever tried as an adult, as well as on others that have been mentioned for CFS, FM and other issues.....I agree they are scary, but the really scary part is that they actually do not even cover all that they should - you would not believe all the info that drug companies manage to leave off of their warnings (& the fact that other drugs carry similar warnings is not a reason to dismiss the warnings, but rather a reason to really take a careful look at the risk vs benefits before trying them)

    I have read a ton about meds (partially for personal interest and partially bc as a counselor - though not a currently working one due to disability - I have needed to be aware of this stuff for professional reasons, too)...what I have read ranges from the professional literature to the stuff given to patients to the actual studies to other stuff written by Drs who are very much against using meds to professional journals to mainstream books to real patient experiences, etc

    taking what I read, as well as personal accounts, into consideration, I have weighed the risks/benefits and in the past have decided to try several different meds.....without fail, I have reacted badly to ALL of them, at least to some degree....MOST of them I have reacted so badly to, I decided were not worth it, but there are a few that I do take in very small amounts when I absolutely have to (when the pain becomes extreme and unrelenting or when the sleepless nights go on for some time and nothing else seems to be working)

    since I know how much it stinks to have constant fatigue, pain, sleeplessness, etc, and I know that some people do get some relief with some drugs, I would never tell anyone to avoid all meds......I do believe, though, that people should be as informed as possible about all the risks to taking meds...most people never really get the info they need to be able to make such an informed decision....if they really knew enough about what they were taking, I think most people would not want to take the risks (but in some cases they would)

    as to xyrem, there have certainly been plenty of people who have benefited ( with a small amount of improvement), but there have also been plenty who have been harmed....and for those who do benefit, most (80%) are also taking a stimulant drug during the day (that is a whole other issue, but suffice it to say that there are many issues with that, too, esp for people with CFS)...and the research on xyrem pertains to people who have a different disorder - a similar one, yes, and as such, similar treatment might work similarly....but it might not
  13. cfsgeorge

    cfsgeorge New Member

    I don't know how i'll react to xyrem/ghb now that i'm so sick and disabled with CFS. I know most chemicals make me sick or intolerant such as alcohol, smoke, pesticides, perfumes, etc. We fitness freaks used ghb along with many other supplements to shed fat while we slept. It was not used to "sleep" because healthy people can sleep without medicating themselves. There was no other use of GHB for those that were obsessesed with the health and fitness lifestyle.

    I do feel that it is safe and the best sleep med out right now. I can sleep +8hours every night with my current sleep meds and supplements, but i'm still disabled and wake up horribly "unrefreshed". There is still something big missing in my sleep and i feel ghb can help correct that.

    As for price, a bottle of GHB use to cost about $20 at GNC. Due to its "date-rape drug" label, it became illegal as a nutritional supplement and now costs about $700/bottle from Jazz. It'll cost $700-$1400/month for Xyrem/GHB now. I can't afford that and i don't know if my insurance will cover it. This drug is so cheap to make with no research funds needed. the only real costs to jazz was the clinical trials and for marketing. Buy jazz stocks as the need for xyrem will skyrocket when it'll be fda approved for FM, CFS, and Parkinson's.

    I'd recommend everyone to do their own research on any drugs they take and to talk to their docs. here are a few links i'd recommend:
  14. AuntTammie

    AuntTammie New Member

    why people don't take growth hormone instead of xyrem......I do know that a lot of people with CFS (and maybe FM) are low in growth hormone and if ghb (xyrem) causes the body to release growth hormone, why wouldn't we just skip the ghb and go rt to the hormone? and on another note, if we are low on the hormone, is it bc we cannot release enough of it, or bc we cannot make enough (if it's the first one, then ghb would make some sense, but if it's the second, then ghb would not make sense)...if I am making sense?! LOL - sorry - foggy time here rt now

    also a former Dr mentioned that there is something that can be used instead of growth hormone, but he said that in order for the body to utilize it, someone would have to be able to exercise aerobically for at least 30 minutes straight daily.....unfortunately, he mentioned this before I had any info on this subject, so I didn't know enough to be able to ask him more about it, and he is no longer practicing....any idea what he was talking about?
  15. brentired

    brentired New Member

    supposed to get mine this next week, i hope it works but i am bypolar, he says i have to come off my depression meds. Do you have this or has he said anything to you about this.
  16. cfsgeorge

    cfsgeorge New Member

    Xyrem/GHB therapy is much much safer than HGH therapy for CFS and FM IMPO. First off, most of us do not have a clinical GH deficientcy. Second, all of us have the awful sleep problems that GHB can help enourmously, but GH therapy alone do not. Thirdly, being on GH therapy long term means your body will stop producing it's own GH and you will have to take daily injections of GH for the rest of your life. Fourthly, PWC who underwent GH therapy alone felt better, but in the long term developed osteoporitic/fractured spine and bones.

    What makes xyrem so effective and safe for people with FM and CFS is that it allows us to get the best deep sleep possible. More importantly, it allows our own bodies to produce and release more GH instead of "forcing" more GH in our bodies by exogenous means(HGH injections). Our body is still regulating the amount so there is no permanent downregulation as seen in all hormone replacement and neurotransmitter therapies(A/D's). There are many safe and "natural" ways to increase our hormonal and neurotransmitter levels w/o the risks of a permanent shutdown or side-effects of overdosing.
  17. Sachmo500

    Sachmo500 New Member

    Total agreement. Without Lyrica, I can not get out of my own way.
    With Lyrica, I can work

    JEANSKI New Member

    Brentired- My sister is bipolar and there is no way I would advocate coming off your meds to take something for you FM. There are other options for FM and managing pain and fatiguebut not for Bipolar. I can't believe your dr would be okay with this! Please think hard on this.

    cfsgeorge: I had FM since I was 13, dx at 15. It is unfortunate I think alot of kids get treated as if they are lazy or are treated for depression when it's not that at all. My PCP kept saying it was the depression that was causing my pain when it was the pain that was causing the depression. Fortunately I think more dr's are aware, not nearly enough for peds I fear, but better than when I was growing up just a short time ago.
  19. louiesgirl2

    louiesgirl2 New Member

    Sounds interesting was reading up on it, however, do to having sleep apnea, may not be drug of choice for me. Side effects listed could be problem with those with sleep apnea, may increase symptoms. Here it is word for word from site.

    Other medical problems—The presence of other medical problems may affect the use of sodium oxybate. Make sure you tell your healthcare professional if you have any other medical problems, especially:

    Breathing problems such as:
    Hypopnea (abnormally slow, shallow breathing) or
    Sleep apnea (stopping breathing during sleep)
    Use of sodium oxybate may make these conditions worse
    Depression, history of, or
    Suicide, attempted—Use of sodium oxybate may worsen these conditions
    Drug abuse or dependence, history of—Dependence on sodium oxybate may be more likely to develop
    Heart failure, history, or
    Hypertension (high blood pressure) or
    Kidney problems—The amount of sodium in this medicine may make these conditions worse
    Liver problems—May increase the amount of sodium oxybate in the body and a smaller dose may be needed

    Succinic semialdehyde dehydrogenase deficiency (a rare, inborn metabolism deficiency)—Sodium oxybate should not be taken
  20. AuntTammie

    AuntTammie New Member

    thanks for the makes sense