Don't Recall Fibromyalgia Drug Savella - It Works
The debate in the fibro world has been centered around the possible recall of Savella and whether it is safe or not. I published a short post on January 20 when Public Citizen sent a petition demanding that the FDA recall the fibromyalgia drug Savella (Milnacipran) and take it off the market.
Below is an email I wrote to the consumer advocacy group. I want them to know that Savella works for me and I'm against the ban.
I propose instead that:
- Savella remain on the market with stronger labeling about possible dangerous side effects; and
- A long-term study about the efficacy of Savella be required.
Dear Public Citizen:
I am writing because of my concern about your efforts to ban Savella (Milnacipran) for use by fibromyalgia (FMS) patients in the U.S.
I have had very good results with Savella and am cognizant of its side effects. Therefore, I feel it is important for me to inform you of my positive experience with Savella. Savella has been very effective in reducing my overall body pain over the last 8 months.
I have been suffering from daily chronic pain - 7 to 9 on a 10-point scale. I also developed migraines, myofascial pain, photo-phobia, nausea/vomiting, irritable bowel syndrome (IBS), sleep disorder and fibro fog. I am currently on Social Security Disability because I am no longer able to work and spend most of my time in bed. Pain prevents most normal daily activities. I have tried many medications, including Lyrica and Cymbalta, which had severe side effects and did not affect my pain at all.
Savella is the only medication that has helped my overall body pain. Since I have been using Savella, my overall body pain has been reduced to 4 to 7 on a 10-point scale. As a result of having less pain, I have been able to increase my physical activity and start using the computer again. I went from only being able to walk continuously for 3 minutes on my good days before I started taking Savella, to 11 minutes now. Savella has been a lifesaver for me and given me hope that my life will be better.
I understand that like other medications, Savella has serious risks. My doctors and I have discussed these risks, and they monitor my blood pressure, heart rate and evaluate all the medications I am taking. I closely monitor any shifts in my mood for signs of depression since I have had to stop taking other medication that altered my moods. My blood and heart rate were normal at a doctor's visit last week.
In the interest of those of us who are experiencing pain relief from Savella, I urge Public Citizen to modify their demand for a ban on Savella to demanding a stronger labeling that highlights possible dangerous side effects and requiring a long-term study of the efficacy of Savella while it remains on the market. These two actions would allow patients like me to benefit from Savella and protect all of us from any long term side effects.
How do you feel about Savella being recalled? Do you think it should be taken off the market? Has Savella worked for you?
If you'd like to send an email to Public Citizen's Health Research Group, you can do so here.
- Petition to Ban Fibromyalgia Drug Savella, January 20, 2010
- Press Release: Public Citizen Petition to FDA: Dangerous Fibromyalgia Drug Should Be Pulled From the Market
* Thanks Fibro Mom for helping me edit this and working through a bad bout of fibro fog.
Dot
Reader Comments (10)
There seems to be strong feelings on both sides about Savella. Some people love it, others hate it. I don't take it, so I can't offer that kind of opinion.
The FDA should make a determination about its uses. Doing a controlled study or putting a warning label on it seem equally prudent. However, I've noticed that the FDA often puts drugs on the market without ample, well-researched studies and then out of embarassment, outside pressure from lobbyists or something, they fail to do the right thing. Let's hope they do do what is right for the people they serve- us.
Cinda -- Thanks for your well thought-out comment. I agree with you - let's hope that the FDA makes a decision about Savella that best safeguards our health and well-being.
I have been a part of the clinical study of Savella. I have been taking the drug for over 2 years and have had great benifit from it. Forest Labritories, the company that manufactures Savella, is continuing to do long term studies as well as a study that monitors how people react when taken off the medication. I know from my participation in hte study that they were doing clinical trials for at least 3 years before FDA approval came. I feel that there is a lot of information already there, if people choose to look for it. I have not read the petition to ban Savella so I cannot comment on their point of view. I do however think that there are a lot of peole that are taking this drug who are seeing a lot of benifit from it.
Thank you for getting the information out there.
Hi Sarah - It's so great to hear from an actual participant in the Savella clinical study! The petition (you can read it here) basically questions Savella's pain benefits vs. risks. So it's important for those of us who are being helped by Savella to speak out. It's also very good to know that Forrest Laboratories is conducting long-term studies. Thank you for your very helpful comment.
I really like this blog post, it has some great info. Thank you and keep up good work.
trading for a living
Just wanted you to know that I think this post is newsworthy and worth passing on, so I'm placing it in the "Healthcare Links" on my website, Health Matters Show. I hope lots of people check it out and stop by your blog. Keep up the good work! (PS- I'd appreciate a link back.) :-)
Savella works except I had a heart attack 3 months after starting to take it; had 2 weeks of heavy sweating, feeling blue but definite improvement ....but need my heart so had to stop on advice of cardiologist.
Dot & Fibro Mom,
I'm glad that this med works for you but I think everyone with fibromyalgia needs to use more brain power to combat the effects and rely on drugs less, not more.
I was diagnosed in 1990 at age 23, so I have lived with fibro for 20 years now; almost half my life. The only meds I have ever taken are amatryptyline (sp?) at the very beginning to help protect my phase 4 sleep and Wellbutrin for the past 12 years to help balance out brain chemicals. Everything else I have done has been drug free. My chiropractor helps with overall body pain and IBS symptoms, massage helps when there is a specific area that has flared up and the rest is diet, exercise, rest, listening to my body and ATTITUDE! Drugs are only an aid, not a cure. The only way to beat fibro is to not allow it to beat you.
I am currently sitting on my couch with my left leg in an immobolizer from ankle to groin because my knee was broken over the weekend. This happened six weeks after having surgery to the same knee to repair the meniscus which was damaged in May last year, along with the MCL, LCL, ACL and knee cap, plus a bone bruise and a blood clot. Those of you with fibro reading this can probably imagine the level of pain I've been experiencing the past four days, even with oxycodone to help mitigate it, but I will not allow this or fibro to control my life. IT IS MY LIFE AND I AM IN CONTROL!!!
More fibro people need to take more responsibility for their own quality of life. Yes the pain is real, how you deal with it is up to you. CONTROL YOUR LIFE...DON'T LET FIBRO CONTROL YOU!
Your link to Public Citizen's Health Research Group leads me only to a page that says the link is no good. I believe the risks of this medication far outweigh the benefits. Thank goodness I did my research before taking savella. My primary physician failed to take into account I've had a triple bypass (when I was 45), suffer from tachycardia and high blood pressure (controlled somewhat by meds), and I had suicidal thoughts after being on another med that messed with serotonin. Sheesh, what was he thinking? Read the scientific studies, people. Twenty percent of the people who took it had adverse reactions. This is unacceptable. If they don't recall it, there will be plenty of lawsuits down the line.
John Smith- I really appreciate your feedback and hearing that the content was helpful.
Cinda- Thank you so much for linking to us from Health Matters Show. We're very honored!
Howard- I hope you are feeling better and am so, so sorry to hear about your heart attack. It seems that all the drugs that work have really potent side effects. Your reaction is really worth hearing about and considering. Thanks so much for posting. Hope you've found a treatment that's better for you.
Morgan- Your positive, can-do attitude is inspiring. Especially because chronic pain and fatigue can be so draining and dispiriting. The fact that you've just had an operation and are able to still encourage others is very heartening. Thanks for sharing your story. Wishing you a speedy recovery!
Bev- Thank you for alerting me that the Public Citizen press release link was outdated. Just updated it so everyone can now access Public Citizen's press releaseas well as their petition to the FDA to ban Savella. I'm so sorry to hear about your doctor prescribing Savella without fully addressing the possible adverse reactions. I completely agree with you about patients doing our own research and trying to be as informed as we can. Thanks so much for sharing your experience and concerns with us!