Cymbalta Approved as Fibromyalgia Treatment
And then there were two! The FDA has approved Cymbalta (duloxetine) for treating fibromyalgia. Lyrica (pregabalin) was approved about a year ago.
Cymbalta is an SNRI (serotonin norepinephrine reuptake inhibitor), which means that it increases how much of the neurotransmitters serotonin and norepinephrine are available to your brain. Levels of both neurotransmitters are generally low in people with fibromyalgia, which is believed to be partially responsible for symptoms such as pain amplification, mood swings and irritability.
Here are the highlights of 2 double-blind, placebo-controlled clinical trials that Cymbalta-manufacturer Eli Lilly presented to the FDA:
- Pain improved at least 30% for just over half of participants during the first week.
- About 65% of participants reported feeling better at the end of the studies.
- Cymbalta faired much better than placebo on the Fibromyalgia Impact Questionnaire, which is used to gauge aspects of health and functionality.
- The drop-out rate due to adverse effects were 20% and 12%.
The most common side effects of Cymbalta in studies were:
- Nausea (29%)
- Dry mouth (18%)
- Constipation (15%)
- Decreased appetite (11%)
- Sleepiness (11%)
- Increased sweating (7%)
- Agitation (6%)
Doctors have prescribed Cymbalta as a fibromyalgia treatment for a long time. What changes with FDA approval, however, is that more doctors will be aware of it as a treatment option, and also that more insurance companies may be willing to pay for it now. We might also see more TV and magazine ads that raise public awareness of fibromyalgia.
Other drugs working toward FDA approval include: milnacipran, for which a decision is expected by the end of the year; Effirma (oral flupirtine), which has recently received the FDA's permission to start clinical trials in the U.S; and narcolopsy drug sodium oxybate (the drug in Xyrem), which is now moving into Phase III clinical trials.
Have you taken Cymbalta? Did it work for you? Leave a comment here or in About.com's Fibromyalgia & Chronic Fatigue Syndrome forum (look under Newsletter & Blog topics.)
Comments
I have been on Cymbalta since I was first diagnosed with Fibromylagia and severe sleep disorders about 2 years ago. I am a 57 yo woman who has probably had Fibomyalgia since I was a child and has been searching for a diagnosis for all of these years. For about 10 yrs I was being treated by a psychiatrist for depression and prescribed Zoloft (SSRI).
I had no problems transitioning to the Cymbalta and have found that I am far more even — less reactive and my head is clearer on the Cymbalta. The side effects listed are common (from my understanding) to SSRI’s and unfortunately the same symptoms that I suffer from as a person w/Fibromyalgia. But I never felt that any of my symptoms became worse when I changed to this medication.
As an aside — with all of the drugs that I take I also have started to do acupuncture again. This time Chinese acupuncture. My greatest mistake was taking a break from treatment for several years. It is expensive and time consuming. But for me worth it all.
I no longer see the psychiatrist but do continue on the Cymbalta and am doing great!
I tried Cymbalta twice and had to stop due to extreme nausea and stomach pain. I was on it for about 4 weeks each time, and did not notice any beneficial effects unfortunately.
READ READ READ everything you can on the internet and talk to others who have taken it before you consider taking this drug. I took the Lyrica/Cymbalta “cocktail” for 4.5 months. For the first 3.5 months the results were wonderful. I did gain 12 pounds, but I felt better and was pain free for the first time in 18 years. Then the bottom started to fall out. I became increasingly drowsy to the point of falling asleep whenever I sat still for even a small period of time. Working became an ordeal. I tapered off the Lyrica, but the sleepiness did not subside. So, I tapered off the Cymbalta. I am now on my 10th day of suffering the Cymbalta withdrawal symptoms: extreme constant nausea, diarrea, dizziness, brain zaps, headache. If you read, you will find this is not unusual. Of course, withdrawal is a risk from any prescription drug, but it appears this one has more incidents than not.
2 years ago I was rolled up in a ball in bed, severely malnurished, dehydrated, stressed, had a systemic Candida Yeast infection. I couldn’t sleep, and my muscle ached from head to toe and was in alot pain. I don’t know how I returned to work after a 4 week leave of absence that resulting in only being sicker than when I left because allergy shots and allergist treatment of antibiotics were making matters worse. With my head in my hand, I did my own research and practically divorced any pain meds. I got my dr. to give me Diflugan for the yeast issues. I started to get better with the anti candida diet, I moved on to ever book I could get my hand on, and the Dr. agreed I possible had FMS. So, more books, nutrition, suppliments and a new life style. I purchased one book “reversing fibromyalgia. I am happy to say, that I am virtually pain free. I get almost every day, with only minor aches and pains on bad weather days now. I have chemical sensitivities, but I am almost 90% better. It can be done. It was a bit expensive trying this suppliment and that, organic food. I know there are those worse off and need drugs, but I feel that diet nutrition is the way to go. If feel that I do not trust the FDA to approve new drugs, that may only be found after everyone has been taking them for a while, that may cause other health issues. We need to approach our government to stop putting chemicals and artificial ingredients approved by the FDA as safe, when they are not. The standards for quality food supply are very low, and it is all about money and not our health. Fibromyalgia can be reversed. We need healthy food supplies available for everyone. and this country needs to promote that. This my friends is your long term health care program. Think about it. Does your government want to pay your social security when you are old, or are they hoping you won’t make it to collect?
I HAVE BEEN ON CYMBALTA FOR ABOUT 2 YEARS AND IT HAS HELPED MY DEPRSSION AND MOOD SWINGS I AM ON 60MG A DAY AND ALSO ON DURAGESIC PACTCHES MAYBE IF I CAN GO HIGHER ON MY MG’S I CAN GET OFF THE PATCH. I THINK TIS IS A GREAT BREAK THROUGH.
When first starting Cymbalta, I experienced total freedom from pain. After a few months the effect wore off.
I think taking Cymbalta and Lyrica at the same time is redundant…unless you are taking Cymblata for depression. I would think anyone would have some severe side-effects from that cocktail.
I don’t believe our government is trying to knock us off either. Cymbalta certainly has it uses in the medical arena and works wonderfully for some; not so well for others.
Take what works for you…if it help your pain and makes you feel more human. I know I felt 100% better with my first dosage of Cymbalta. I’m taking Lyrica now…but not both together.
Good luck to all, whatever your medicine is.
I am at my wit’s end. Have had FM for 15 years. Pain is getting so bad especially in the morning that I am having to take 2 Panadeine Forte to get out of bed. I had high hopes of trying one of these newly approved drugs though SSRIs send me troppo. These side effects have scared me off.
I was diagnosed with chronic fatigue syndrome around 15 years ago, an after effect of having Guillain-Barre Syndrome 25 years ago. The only drug that could keep th pain at a low level was morphine. Last September I had 10 vertebrae fused; the surgeon refused to treat my pain adequately. Since the day of surgery I’ve not had any morphine; in consequence I’m in pain at all times.
Apart from that, I was given Lyrica to help treat the pain; as we all know, Lyrica also is very sedating, with the problem of falling asleep when I sit and remain still.
With all the problems I have, I became quite depressed. After trying various meds, I eventually came to Cymbalta. My dosage is 90 mg per day, in one dose. I have no side affects from this med, other than sleepiness, but my mood is excellent. It seems, no matter how bad things can be, I remain a grateful and smiling person. I don’t care if that is so only because of meds. Without the Cymbalta, I may have already left this mortal coil.
Good luck to all you readers with chronic pain or fibromyalgia. Let’s hope the research continues and maybe some day we all will be pain free.