NEWSBRIEF: An FDA letter calls Eli Lilly's print ads for Cymbalta (duloxetine) as a fibromyalgia treatment misleading.
The letter says a magazine ad doesn't adequately convey the risks of taking the drug. Risk information was on an adjacent page but not in the body of the ad, which the FDA calls a "misleading presentation."
The letter also takes issue with an ad aimed at doctors, which it says overstates the drug's effectiveness and minimizes risks. Again, risk information was separated from efficacy claims.
Cymbalta was approved as a fibromyalgia treatment in June 2008. It's a serotonin-norepinephrine reuptake inhibitor (SNRI) aimed at correcting the neurotransmitter dysregulation associated with the condition. To date, it's one of only 3 drugs approved for fibromyalgia.
- Learn more: Cymbalta Profile
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I was given Cymbalta for bipolar disorder and was told it would help my chronic fatigue syndrome symptoms, which it did, very well. However, about two months into the lowest dose possible (20 mg./day), I started to get diarrhea and cramping, finally to the point where I had to cut it to 20 mg. on alternate days. Still had the same problems, so quit it altogether. I think it flared up a latent (or maybe not so latent) irritable bowel syndrome. I’m still having a crampy feeling, although the diarrhea has mostly stopped. If my bowels heal up completely, I’d like to go back on the Cymbalta at half-dose (20 mg. on alternate days), because it was very helpful for the CFS. Now, my psychiatrist believes the Cymbalta has nothing to do with my problems and insisted I go to my medical doctor for testing. I finally gave in, reluctantly so, because I knew they’d find nothing – and that was exactly the case after bloodwork and stool testing. They told me to go see a gastroenterologist if it keeps up, but I seriously doubt this will be necessary and would be a huge waste of money. These doctors just don’t know their own meds!
I have been taking Cymbalta for almost 2 years. I take 60mg a day. I have found that higher doses do cause adverse reactions. However, I also know that when I stopped taking it (twice), my chronic pain went up significantly – approx. 30%. No matter what your doctor says, read all the info you can on any drug you take. Check all interactions with drugs, lifestyle habits and food. Cymbalta has greatly reduced my need of hydrocodone. At 60mgs, I no longer have any noticable side effects and I am very glad that I take it.
Cymbalta made me feel lousy. For me, opioids (low dose methadone) and baclofen (muscle relaxant) work well enough. They’re generic, so much is known about them.
I worry that opioids will not be available to fibro patients.
Any comments about that?
My doctor told me to stay away from these new FM drugs…One doc put me on Cymbalta and i started feeling like i was going crazy. I only take the old standard narcotic pain meds and won’t try any new drug ever. The drug companies that sell these new drugs are just using us to make a buck.
Well that’s an uneducated answer to it! Drugs affect different people in different ways. What works for some really well doesn’t work for others. I know there are companies out to just make a buck, but there are also those who truly help people feel better and have a better quality of life.
I was prescribed Cymbalta when I suffered a severe fibro flare. I am late 40’s and my legs hurt so badly I had to use a cane to rise from a chair and the toilet. The Cymbalta helped me alot and I still take it. I have no adverse side effects, and no longer need the cane. I thank God that there are people who work to make these medications for people who need them. However, I do worry if I ever want to stop taking it that the withdrawal symptoms will be unbearable. Just missing a dose or two causes extremely uncomfortable symptoms.
Cymbalta is not a new drug – it’s been on the market for years as an anti-depressant. What’s new is the approval for treatment of fibromyalgia. My doctor prescribed the “standard” dose – 60 mg – and I was pain-free for the first time in years. Then, slowly, I slipped into depression to the point where I contemplated suicide. My doctor and I deduced that a much lower dose – 20 mg – is all that’s needed to reduce pain for me. (I acknowledge that Cymbalta doesn’t work when major fatigue sets in; but managing this disease requires that I manage my energy so that doesn’t happen.) Perhaps all that’s needed is more education of the medical community.
I took it for 3 days. I was so sick within an hour of taking it each time. I was in bed the rest of the day. I can’t take 3 days or more out of my life. I have FMS & I need all the time I have to do what I need to do in life.
I have been on Cymbalta for my fibro for about a year. It has helped me tremendously. I am only 24 but could hardly walk from one room to the next during a flare before the Cymbalta. I have not had any bad side effects, other meds did not work for me. Everybody is different. I pay attention to lifestyle and try alternative medicine as well, but sometimes you just need the right medication to improve the quality of your life.
I take cymbalta and lyrica together. They work wonders for me. I am able to do so much more. If you miss a dose of cymbalta you feel horrible and get dizzy and sick but it’s worth it. Just remember to take it regularly and DON’T forget to refill your prescription before you run out. But cymblata and lyrica work great together.
I had a severe reaction after taking just one pill of cymbalta. Trembling jaw, high blood pressure, temperature, and feeling disorientated. I was rushed via ambulance from doctors office then from emergency sent to mental ward because it is an antidepressant. I was kept of involunary treatment order for 1 year though no treatment was given simply because I had changed states/geography. I hate having Chronic Fatigue Syndrome.
I tried Cymbalta and lasted all of about a week or two. It made me shake so badly I couldn’t control my hands, and all of my muscles were in tremor at an extremely low but annoying as heck amplitude.
That was a month or so ago. I still have some shakes and tremors in my hands that haven’t fully gone away.
It’s unfortunate, because it did seem to help the pain, but I can’t go through life shaking worse than somebody with Parkinson’s.
As others have mentioned, everyone is different and thus Cymbalta might work better for one person compared to another. Individual differences in body chemistry, lifestyle factors and other variables could play a role in its overall effectiveness, and I think reading others’ personal experiences and seeing the variance shows that.
Cymbalta has been extremely effective for both my MDD, GAD and Fibro. Nothing else has worked like it. I know everyone is different but having tried everything, including Lyrica which resulted in a 40 lb weight gain and extreme fatigue, Cymbalta is a miracle drug for me. You have to try it because it’s different for everyone. I went from not being able to work to working again. I still have flares and pain but it’s manageable. Also, you have to be proactive – small walks daily, stretches daily, and yoga when you can fit it in. I’m not a saint and I know it’s hard. I fight to get up every morning. But people who are on vidcodin and even methodone like i’ve read on other posts are crazy! Why put your body in the hands of serious narcotics! Try something that adjusts the hormones and pain receptors and take charge – you can do it!