Potential New Fibromyalgia Treatment - So Just What Does "Well Tolerated" Mean?
A potential fibromyalgia (FMS) drug being touted as "well tolerated" caused "adverse events" that drove a lot of people out of the study - nearly 20% of people on a low dosage, and just over 27% of people on a higher one. Maybe my expectations are too high, but when 1 of every 4 or 5 people can't take it, that doesn't sound terribly well tolerated to me.
The drug in question here is milnacipran, an antidepressant (NSRI) that's gone on the market in about 50 countries over the past decade. It's never been approved for any purpose in the U.S., but the FDA is considering it right now as a fibromyalgia treatment. We could have a decision by the end of the year.
For some perspective, in one clinical trial of Lyrica (pregabalin), 17% of people had adverse events (generally severe side effects) bad enough that they left the study. The FDA almost rejected Lyrica because of the potential for side effects, but then, basically, decided having something on the market for us was better than nothing. And that's probably true - even though some of us can't tolerate Lyrica and it doesn't do much for others, for some people it has been a miracle drug.
So what do you think - am I being too picky? Or would it be more accurate for researchers to say these drugs are "moderately well tolerated"? Leave your comments here or in About.com's Fibromyalgia & Chronic Fatigue Syndrome forum.
Other Milnacipran Study Results
- A significant number of study participants reported feeling 30% better.
- Pain relief started after about a week.
- 90% of adverse events were classified as "mild" or "moderately severe."
- Funding for the study came from the drug's manufacturers.
Comments
Well, I’m one of those on the milnacipran study who stuck it out. The big side effect that does most people in is nausea. The first month or so on the med can cause significant nausea. But I’m telling you right now it’s worth it. Totally, totally worth it.
They’ve been working with a scaling up of dosage to help with the nausea. You start on a lower dose and slowly ramp the dose up. That has helped with the problem. In my first trial, they ramped the dosage up fairly quickly and I had a great deal more nausea. But when I transferred to the 3year study, after washing off the drug for 3 weeks, they used a slower ramping up of the dosage and I had much less nausea.
And as I said, being sick to your stomach for a month is well worth the benefits of the milnacipran, not just with pain control, but with fatigue improvement as well. Used to be, it was all I could do to maintain my job. Anything outside of that was just about impossible for me. Now I’m working full time as well as volunteering on some political campaigns. Last weekend, I spent the entire weekend ferrying the candidate around and still was able to work all week. That would have been impossible in the past.
So, while the initial side effects are hard, I highly encourage anyone who can make it through to volunteer for the study. Milnacipran has just been miracle drug for me.
I’ve heard rumors of a combined milnacipran/lyrica study coming up. If I wasn’t already in the 3 year milnacipran study, I’d so sign up for that one.
Thanks for you comment! How interesting to hear from someone involved in a study!
I hope they do have success finding ways to mitigate the side effects so a lot of us can have the success and return to functionality that you’ve had. Congrats on that! I hope you can find a way to stay on it until it’s approved.
Milnacipran is currently available in Europe (they’ve been using it there for about 10 years). Luckily, I know a doctor in Germany who could get it for me if necessary *laughs*. Thank the Goddess for international relatives.
I worry a bit that the emphasis on anti-depressant drugs as treatment for fibromyalgia might cause a public reaction/medical community reaction in which the disease once again isn’t “real.”
It’s not openly recognized that anti-depressants have other properties that are helpful for fibromyalgia patients (like sedation for help with sleep or a change in the perception of the severity of pain).
I would like to see more drugs from a wider class (pain relief, sleep aids) receive FDA approval for fibromyalgia treatment or better education of the public and medical providers about WHY these anti-depressants help treat fibromyalgia!
I am currently taking Lyrica (on my 2nd month) and am one of the lucky ones who benefited from pain relief. However, I had swelling of hands/feet for the first 4 weeks, and it increased my fatigue levels (still high). But to be able to function for a day & not be knocked out with widespread pain for 3 is worth it. And for those who do not benefit from the drug, at least they are no worse off from trying it and having it fail. If only 50% get a benefit, I believe it is advantageous to go forward with approval.
I am curious if anyone else has been prescribed Mirapex for their fibromyalgia? It’s normally used to in treating Parkinson’s disease and restless legs syndrome. I was on Lyrica a couple of years ago, but then my doctor switched me to Mirapex which took away the pain in my legs. I highly recommend it if you don’t get any relief from Mirapex.
I’m very skeptical about it, because I’m already on an anti-depressant (Paxil) which does nothing for my Fibro at all.
I am afraid of these new drugs as I have not been able to tolerate any type of antidepressant over the years. Fatigue is my biggest complaint. I took 100 mg. of Modafinil for 8 months with great results. It seemed to stop working mid winter so I eventually went off it after trying larger doses. I have been off it for 3 weeks now & am seriously considering going back on it. Fatigue has returned with a vengeance. Perhaps my drug holiday is the answer. I had such excellent results in terms of fatigue, motivation & increased energy level. I felt like I had my life back. Lyrica scares me as the side efects include fatigue. We do each respond differently to drugs. I wonder if any one else has had experiences with Modafinil.
On the contrary…antidepressants HAVE been in the open about treating fibro. symptoms. Fibro. is due to a CNS disorder…antideps. treat that as well as aid in restorative sleep. They are also used for pain…and they do work.