05.28.2015

Why your fibro meds aren’t working

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If you’ve been diagnosed with fibromyalgia, chances are your physician has written you a prescription to try at least one of the three drugs – Lyrica, Cymbalta or Savella – currently approved by the U.S. Food and Drug Administration to treat fibromyalgia.

And chances are you may have been disappointed when those drugs didn’t work.

Well, here’s what your doctor won’t tell you, or maybe he/she doesn’t even realize: The drugs approved to treat fibromyalgia aren’t much better than sugar pills. The results of several clinical trials support this.

The three drugs approved by the U.S. Food & Drug Administration to treat fibromyalgia - Lyrica, Cymbalta and Savella - aren't much better than sugar pills, according to research.

Lyrica

In 2007, Lyrica became the first FDA-approved drug for fibro. At the time of the writing of this post, Lyrica’s website reads, “In clinical studies, many patients taking Lyrica had less fibromyalgia pain compared with patients taking a placebo (53% for Lyrica vs. 33% for placebo), so they felt better and could do more.”

But that statistic paints a somewhat distorted picture of Lyrica’s effectiveness, lumping improved patients into one group. Dig a little deeper into Pfizer’s research, and you’ll find the numbers aren’t nearly as impressive. During Pfizer’s first Lyrica trial for fibro:

  • Only 20-21 percent of patients experienced at least a 50 percent reduction in pain, depending on the administered dose (dosages ranged from 300-600mg a day).
  • Between 34-38 percent reported at least a 30 percent improvement in pain, depending on the dose. On the surface, this sounds ok … until you look at the number of patients who responded in the placebo (i.e. a sugar pill) group. About 27 percent of those patients reported the same 30 percent improvement in pain when taking a placebo! So, Lyrica only outperformed a sugar pill by a few percentage points.

I know Lyrica is a godsend for patients when it works, and I am in no way anti-pharmaceutical, but looking strictly at the numbers, Lyrica’s performance is hardly reliable.

Reading further down into the study, the numbers are even more dismal when you consider that 36 percent of the study’s participants didn’t even complete the trial. Many of those patients dropped out due to adverse side effects, such as dizziness, blurry vision, weight gain, sleepiness, trouble concentrating, swelling of the hands and feet, dry mouth and feeling “high.” (Let me point out that some of these side effects are the very ones we are trying to avoid by taking these medications.)

Cymbalta

Now, let’s move on to Cymbalta. Cymbalta is probably best recognized for its “Depression Hurts” commercials. It gained FDA approval for the treatment of fibro in 2008 following two randomized trials.

Cymbalta also has a less-than-stellar success rate among fibro patients, but to its credit, it does outperform Lyrica:

  • During an initial trial, only about 32-36 percent of patients reported at least a 50 percent reduction in pain, depending on the dosage administered (60mg was given once or twice a day).
  • About 40-46 percent of patients saw at least a 30 percent reduction in pain.
  • The numbers weren’t as good during the second trial, when patients were randomized to take dosages of 20mg, 60mg and 120mg once a day.
  • Almost 35 percent of study participants dropped out of the trials – about half were due to side effects. Nausea, headache, fatigue and sleepiness were the most common side effects cited as reasons for why patients left the studies.

Eli Lilly and Co., Cymbalta’s maker, received a warning from the U.S. Department of Health & Human Services (HHS) several years ago for fudging the drug’s efficacy in advertising. According to an HHS letter addressed to Eli Lilly, the drugmaker’s website and a promotional piece on WebMD.com claimed “more than half [53 percent] of patients with fibromyalgia treated with Cymbalta had a 30 percent improvement in pain severity at study endpoint.”

From the figures above, you can tell this is a clear overstatement of Cymbalta’s effectiveness.

More than 200 U.S. residents are currently suing Eli Lilly, claiming the company didn’t properly warn patients about Cymbalta’s withdrawal symptoms. Patients say they experienced mania, suicidal thoughts, insomnia, “brain zaps” and other disturbing symptoms upon stopping Cymbalta.

Savella

Savella has the poorest performance record of all three FDA-approved drugs. During Savella’s first fibro study:

  • About 18 percent of patients reported at least a 50 percent reduction in pain.
  • About 27 percent had at least a 30 percent decrease in pain. But again, to put this into perspective, about 20 percent of patients taking a placebo also reported a 30 percent reduction in pain. So, here we have yet another fibro medication that’s barely outperforming the placebo. 
  • The numbers were similar during a second trial.
  • As with Lyrica and Cymbalta, large numbers of patients didn’t complete the Savella studies due to side effects. Between 23-26 percent dropped out of studies because of adverse reactions, the most common being nausea, heart palpitations, headache, constipation, increased heart rate, excessive sweating, vomiting and dizziness.

What patients say

Of course, clinical research doesn’t tell us everything about the effectiveness of these drugs. Patient feedback can be even more enlightening.

Last year, The National Pain Foundation and NationalPainReport.com conducted a survey of 1,339 people with fibro, looking at the effectiveness of Lyrica, Cymbalta and Savella.

Here are some highlights from the report:

  • Lyrica: 61 percent said Lyrica does not work at all; 29 percent said it helps a little; and 10 percent said it was very effective.
  • Cymbalta: 60 percent said Cymbalta does not work at all; 32 percent said it helps a little; and only 8 percent said it was very effective.
  • Savella: 68 percent said it does not work at all; 22 percent said it helps a little; and 10 percent said it was very effective.

So, what is the takeaway from all of these numbers? Well, it’s obvious that a few of us do find relief from these drugs, and for that, I am grateful.

But for those of us who are still suffering, let’s hope that one of the new fibro drugs in the works will give us a more reliable, easy-to-tolerate treatment.

Note: All statistics quoted in this post originated from the drug manufacturers’ medication guides for physicians, available for viewing on the drugmakers’ websites. 

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Low dose naltrexone is an emerging treatment for fibromyalgia. In early research studies, about 65 percent of patients experienced a significant reduction of symptoms.

IMC-1 antiviral combo could be next blockbuster fibromyalgia drug

The U.S. Food and Drug Administration has fast tracked Dr. Skip Pridgen’s novel pairing of famciclovir (Famvir), a common antiviral, with celecoxib (Celebrex), an anti-inflammatory arthritis drug, for a phase III trial in 2017. Based on data from a prior phase II trial, the combo known as IMC-1 could give some stiff competition to Lyrica and Cymbalta, two of the most profitable drugs prescribed for fibromyalgia.

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Comments

  1. Weed Oil works.

  2. Cindy Montalbano says:

    I would loved to have been able to read this article, but the Google Ads were covering the written content of the article.

    • Donna Gregory/FedUpwithFatigue.com says:

      Hi Cindy, can you help me troubleshoot? Are you trying to read the post on a phone, tablet or computer? Is the ad that was covering the copy in the sidebar (left hand side of the blog) or w/in the actual post? It would really help me to figure out the issue and get it fixed if you could answer these questions for me. Thank you!

  3. Shelby Lynn says:

    I cannot get the blue banner to stop, go away, whatever one wants to call it, and it is very distracting as well as the fact that it gets in the way. Suggestions?

    • Donna Gregory/FedUpwithFatigue.com says:

      Hey Shelby, I’m sorry but I’m not familiar w/ the specific blue banner that you mentioned. Google generates ads based on your previous browsing history, so the ads change based on who is visiting my website. There should be an x somewhere – it’s usually in the top right hand corner – to cancel any ads out so you don’t see them.

  4. Keith Blowers says:

    I can confirm that having tried both Lyrica and Savella – neither drug gave me any reduction in my symptoms

  5. Kathleen says:

    Hello, I wanted to comment about both Lyrica and Cymbalta. I’ve had Fibromyalgia for an unknown number of years. I was diagnosed in 2012. It has become so severe that I am now wheelchair bound and often bed ridden. I don’t tell you this for sympathy, many others are in the same condition I am . I took Lyrica for nearly two years from 2012 to 2014 in the beginning I thought it was a wonder drug. I was virtually pain free functioning better than I had in many years. As well as off of any narcotics. Then the side effects started, at first they were mild enough to deal with. Dry mouth, constipation , etc. , but don’t all meds give us those fun little gifts. Then came the tinnitus and a drug to counteract that. Next the blurred vision that I didn’t connect to Lyrica until much later. I went to three different eye specialists having previously had near perfect vision. In the final months my hands and feet then my limbs began to swell. At first it was subtle and I attributed it to menopause and the Fibromyalgia itself. Then it became more pronounced. My less than intelligent Dr. at the time told me to lay off the salt I wasn’t eating. I found a different Dr. He had the sense to actually examine me when I showed him my feet and ankles that were now the same size. He quickly weaned me from Lyrica. Even a drop in the dosage proved to help. By the time I was off of it completely my vision returned to normal, my ears stopped ringing and several other smaller problems disappeared. Unfortunately I developed heart congestion in the process from the fluids gathering my body. It took over a year of heavy diuretic daily to relieve that. Let me tell you that was a joy. I still have to have regular heart monitoring. In short Lyrica nearly killed me. Cymbalta while not as dramatic worked for me for nearly a year to relieve some of my pain. I got enough relieve to make it worth taking. It gave me far less side effects. However now I am starting to have the same numbness that starts before water retention , I am not getting pain relief from it any longer and it is tearing up my stomach. The reason I tell this story is in an effort to give others a real life view of what these medications can do. I was in fact a well educated Pharmacy professional. I know the procedure medications go through to get approved. It doesn’t really have a great deal to do with the safety of the consumer anymore. Be aware of what you are taking. Research it carefully first. Even so make sure you are honest with your Dr about how the meds are effecting you. If you have a problem don’t be afraid to say so. Be an advocate for your own health and well being.
    Now it’s back to the drawing board so to speak. Time to find another plan of attack. Good wishes and good rest to all of you. Here’s to finding answers .

    • Anjelin says:

      they tried putting me on Lyrica and Cymbalta. The side effects were immediate and horrible!! I acted like a damn crack addict. I had typically at least 10-15 of the side effects they listed when you go and research them. I am on gabapentin. That is starting to not work. I have had fibromyalgia for 20 yrs now. And the doctors that tell you its not a progressive disease are full of shit! I know what I need, but now doctors are so afraid of giving you real pain meds, its gotten ridiculous. If you ask for pills you know work (my fiance gave me some of his he takes for a bad back and I have friends with fibro that are on things like morphine, nusenta, ambian) they look at you like you’re a drub addict. And I’ve never taken shit enough to be a drug addict! Then they tell you “well if you lose weight, the pain will get better”. Really? I lost 50 lbs and it got worse. Next…. I’m sick of pain and I’m sick of not getting decent sleep.

  6. Greetings Donna,

    Your site is excellent. I do worry about it going increasingly commercial, but one DOES need to make a living. Just continue to keep it honest.

    Sometimes I think I’m like the poster boy for fibro/chronic fatigue/ ME. BTW, what do you think of equating FMS/CFS with ME? For me it was sudden onset 20 years ago after a severe viral infection. Got it before it hardly had a name along with all the classic symptoms that make one’s life almost a living hell. Ran the usual gauntlet of unhelpful doctors and finally got a diagnosis at Mayo Clinic years later. Thank God that through Christ I’m getting a leg up on the depression. Tried the approved drugs with unsatisfactory results. Just gave Cymbalta another try. Got some energy back but it made my mind so freaky I couldn’t stand it, so I quit after 3 days. Was for a long time on VERY high levels of oxy but took myself clear off very, very gradually. Not fun. It was VERY strange when I finally cleared my body of opiates. After the final withdrawals I was almost symptom free for several weeks!!! I cried rivers for shear joy!!!!! Then suddenly it all came back. Ugh! I don’t know how to explain this and would love it it someone could help me know HOW I could be suddenly well, then unwell??? Anyway, couldn’t stand the pain and very reluctantly went back on low levels of morphine and added some gabba. Been getting worse in the last years. I’m convinced that for many, the disease is triggered by an infection that, among other things super activities the immune system. Since I got this I have gotten almost zero colds or flus in the past twenty years. When they pass through my family I just get an extra dose of pain and fatigue for awhile. Frankly I’d much prefer the colds and flus! I’m afraid that my worsening condition is from my immune system being no longer able to maintain its constant, super activated state. I’m concerned. Hoping that some form of canibis might be a help and plan to explore that soon with my understanding doctor. Also checking into getting involved in some medical trials. We shall see.

    Thanks so much for doing this site for us. I’ll be following along and perhaps chiming in if I find anything of interest.

    Once I’m asking if someone can help — Has anyone else had the experience or can explain my getting briefly and gloriously WELL after clearing opiates, only to have symptoms reappear and stay? Some kind of hyperalgesia whip-whop? Can’t stop thinking about it. I’m very, very tempted to clear myself again to experiment but the cost in terms of suffering and even more dysfunction, is frighteningly high. Help, anyone?

    Blessings,
    Wade

    • Donna Gregory/FedUpwithFatigue.com says:

      Hi Wade, have you been properly tested (i.e. iGenex testing, not the tests available through Labcorp/Quest) for Lyme? Lyme symptoms will wax and wane the way you describe. I was recently diagnosed w/ chronic Lyme after being diagnosed w/ fibro in 2014. My doctors say I may get better after my Lyme is put into remission.
      There’s another researcher who believes the herpes virus can cause the same waxing and waning. EBV is another possible culprit, and has been linked to fibro and ME/CFS.
      All of these various bacteria/viruses have treatments, so it’s worth researching them and ruling them out as potentials.
      Here’s a post that I did on the link b/tw Lyme and fibromyalgia a few months ago that discusses how to get properly tested and evaluated: http://fedupwithfatigue.com/lyme-disease-and-fibromyalgia/
      And a post on the herpes/fibro link: http://fedupwithfatigue.com/imc-1-fibromyalgia/
      The more I delve into reading and researching fibro, the more I believe that a lot of us have been misdiagnosed. Dr. David Brady, author of The Fibro Fix, cites a study that indicates up to 2/3 of us may have been misdiagnosed. His book includes a list of other conditions that are frequently misdiagnosed as fibro. I’m currently reading it, and it may be worth your while to pick up a copy. Hope this helps! I encourage all fibro sufferers to never give up their search for answers and relief.

  7. I’m one of the 10% that Savella has been very beneficial aND no side effects. Cymbalta and neurontin did nothing for me.
    This is good in formation that would be helpful for many searching for something, anything that may help.

    • Donna Gregory/FedUpwithFatigue.com says:

      So glad you’re finding some relief from Savella! We need all the treatment options we can get, even if they don’t work for everyone. Gentle hugs to you!

  8. Very interesting + Informative Stuff, Thanks for sharing.

  9. I actually find neurontin and cymbalta very good. Without them I am bed bound and stuck in a wheelchair even in the house. I am on very high doses though and thankfully without side effects. They do help some people. I’m not cured or anything but have basic function back again.

    • Donna Gregory/FedUpwithFatigue.com says:

      Yes, all of these medications help some people, and I’m happy that they’re available to patients who need them. I’m glad you’ve found a combination to help in reducing your symptoms.

  10. I have had fibromyalgia for srveael years and they have tried just about everything on me. I have been to one specialist after another and finally found one at Toronto Western Hopspital who deals mainly with people who have fibro. This guy is fantastic he told me things that were happening to me that I didn’t tell anyone before. This Doctor does a lot of research in fibro and has been written up in the docors journals. I told him all the meds I was on and his response was this Lyrica works for the pain it has to be taken every twelve hours to work effectively, As I have difficulty with depression (due to poor sleep) I take Effexor at night, this is also a sleep aid; because i have insomina I also take a sleeping pill. Now the result is these do knock me out for a good eight hours, however he also told me that because I have fibro no matter how long I sleep I do not get a proper or normal sleep, I find this to be very true. I have found something that gives me energy and it is not a perscribed medication, now for me it works and it is finally nice to be able to do things on my own without help, it is called Flex Protex. If you want to give it a try they do have a web site. Now I live in Canada and I am 52 years old and have lived and fought this disease for almost half of my life. I have been diagnosed with Cronic Fibromyalgia, and with comes IBS, Insomnia, depression not to mention all that lovely pain. I have finally found ways to work with all of this. While there will always be some medication that I have to take there is also the holistic way that is much healthy for me. The less chemicals I put in my body the better I am.I watch my diet very carefully, staying away from all processed foods and dairy and breads/pasta, incuding potatoes they are a killer. It’s not always easy to do this but if you can avoid as much of these as possible I think you will find it will help you. Good Luck Karlynn.

    • admin says:

      Hi Karlynn,
      Thank you for sharing your experience with fibro. I think you’re a perfect example of someone who is doing all they can to manage your fibro effectively. I don’t believe there is one answer or one magic pill. It takes making lots of changes to one’s life. I’m glad you’ve found a formula that works for you.
      Donna

    • Tracy says:

      I have tried specialist after specialist and their answer is to keep testing me for Lupus and MS. I was diagnosed by one doctor with severe Fibromyalgia and have tried all the “Fibro” drugs as well as several anxiety medications that were supposed to help me sleep. I also have severe migraines (several types), Insomnia, and Depression. I’ve tried the diets and I’m on a vitamin regiment I figured out with my own research, but about a month or so ago it stopped helping at all. It didn’t help much, but I was able to get up and walk around. Now, I’m back to having more issues with walking, spasms in my legs, face, and hands, and my blood supply is dropping again before that time of month. Needless to say that leaves me bed bound for at least 2 days, unable to sit up for most of it. I try to avoid hospitals and doctors anymore because they act like I’m making things up. The last time I passed out in public and ended up in a hospital they refused to believe I didn’t take something that lowered my blood pressure so low. I told them to test me for everything if they didn’t believe me. They finally released me when all my tests came back clear, but I get this reaction every time. My body has a mind of it’s own and I’m the target when they can’t figure out what is going on with me. I had a mini stroke several years ago and they kept me overnight thinking I was faking. It took a neurologist who happened to specialize in migraines to tell them otherwise. They ignored that I seized because my sugar was 35 when the Ambulance got there. Does anyone else have this problem? I’m hurting so bad all the time and need help, but I hate being labeled as someone looking for attention, a liar, and even a druggie. I look like a normal person on the outside so I’m confused about why I get treated so badly. I generally try to make sure my husband can go with me, because this doesn’t happen as often with him around.

      • Alexis Tudor says:

        In med school it is a requirement for all Dr’s to take condescension 101, arrogance 102. Some forget the material of these classes but most don’t. Part of the mentality is, “If I can’t figure out what is wrong with you as a Dr., then it must all be in your head, because you must be the flawed one here.”

Trackbacks

  1. […] University. Although small, the Stanford studies found LDN is actually more effective than the three drugs currently approved by the U.S. Food and Drug Administration to treat fibromyalgia. Thousands of fibromyalgia patients […]

  2. […] the three drugs currently approved by the U.S. Food and Drug Administration to treat fibromyalgia, Cymbalta is actually the most effective. And it’s also the most affordable fibro drug because there’s a generic […]

  3. […] is not my intent to harm Eli Lilly. Based on clinical studies, Cymbalta is the most effective pharmaceutical treatment for fibromyalgia. There are some in the […]

  4. […] by the U.S. Food and Drug Administration for fibromyalgia – Lyrica, Cymbalta and Savella. None of them work very well, and all of them sometimes cause nasty side effects in certain patients. The best performer of the […]

  5. […] The three drugs approved by the U.S. Food and Drug Administration – Lyrica, Cymbalta and Savella – all affect the CNS in some way. If it was found that fibromyalgia is not a CNS disorder, then that would eliminate physicians’ reasoning for prescribing these drugs. It would also help to explain why they help only about one-third of fibro patients. […]

  6. […] Since I’m publishing the news early this week, I thought I would feature an older post from my archives. I wrote this soon after starting my blog, so I never got the exposure it deserved. Ever wonder why you didn’t get results from Lyrica or Cymbalta? This is why… […]

  7. […] to calm the central nervous system. They do not affect the immune system. That could explain why none of these drugs work very well in fibro […]

  8. […] Why your fibro meds aren’t working […]

  9. […] The drugs approved to treat fibromyalgia don’t work for most of us. In fact, they are not much better than sugar pills. Donna over at Fed Up With Fatigue breaks down the clinical trials that support this in her post Why Your Fibro Meds Aren’t Working. […]

  10. […] una reducción del 50 por ciento o más en el dolor después de 16 semanas de tratamiento. Eso es un poco mejor que Cymbalta , el más eficaz de los tres medicamentos aprobados por la FDA […]

  11. […] Why your fibro meds aren’t working […]

  12. […] I remember my rheumatologist sharing a surprising statistic that I’ve since verified through my own research: The most effective fibromyalgia drugs provide at least a 50 percent reduction in pain in only […]

  13. […] Why your fibro meds aren’t working | Fed Up with Fatigue […]

  14. […] I remember my rheumatologist sharing a surprising statistic that I’ve since verified through my own research: The most effective fibromyalgia drugs provide at least a 50 percent reduction in pain in only […]

  15. […] Why your fibro meds aren’t working […]

  16. […] Why your fibro meds aren’t working […]

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