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FDA Urged to Pull Fibromyalgia Drug Off Market

January 22nd, 2010 by Michelle Hamilton


Thursday January 21, 2010

NEWSBRIEF: A nonprofit group called Public Citizen is asking the FDA to immediately yank the fibromyalgia drug Savella (milnacipran) off the market. The group's petition says the drug's dangers outweigh its benefits.

The side effects listed by the group include:

  • Raised blood pressure
  • Increased heart rate
  • Suicidal thoughts

The petition also states that Savella offers "only a marginal effect on pain."

Savella became FDA approved for fibromyalgia in 2009. It's a serotonin-norepinephrine reuptake inhibitor (SNRI), similar to Cymbalta (duloxetine), but unique in that it raises norepinephrine more than serotonin. Both of these neurotransmitters are frequently low in people with fibromyalgia.

On its website, Public Citizen describes itself as "a national, nonprofit consumer advocacy organization founded in 1971 to represent consumer interests in Congress, the executive branch and the courts." Its Health Research Group focuses on drug safety and public health.

Public Citizen has criticized Cymbalta over liver toxicity. It's also placed Lyrica (pregabalin) on its "do not use" list for neuropathic pain, saying risks outweigh benefits. Savella, Cymbalta and Lyrica are the only drugs currently FDA approved for fibromyalgia.

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  • Lynnette

    I agree that these are dangerous drugs when not used properly. My biggest c/o is drug reps giving dose pacs to get you to a high dosage of the med. This is not the proper tried and true way to use anti depressants. You start on the lowest dose and stay there until you see some effects, then increase in increments to achieve maximum therapeutic benefits. I am on Savella but I had to direct my dosing. I get the most benefits for my fibro at the lowest dose. It relieves the lead limb type of fatigue. I had to go higher but have only went to 50mg (over a 4 mnth period.) I take samE to supplement my serotonin needs. People want immediate action. Well, those days are over for us. The reason so many people fail at these drugs is that they don't take the time to read and assess their bodies response. These physiologic responses are subtle and one good response builds on another.



    Lyrica, for instance. It is like having a bitch for a best friend. You want her around but man, does she irritate you sometimes. Lyrica has been extremely beneficial for me, but the side effects can be awful. Within about 6 weeks of taking it I could walk with a normal stride. One day a few weeks later I noticed my severe case of plantar fasciitis was nearly gone. The lyrica, for me, seems to ease pain and stiffness in the groin area and loosens up the joints or tendons so my steps are more normal. I have thought that was a "placebo" effect because that's not what it is supposed to do. But I have weaned off it 3 separate times and the symptoms come back. I fluctuate between 100 and 200mg 2xs/day. My side effects are swelling (hate it), and early on it gave me the google eyes. (couldn't focus good, double vision when fatigued). Most of these are dose related. The swelling is here to stay (had a problem with that before lyrica, but it got worse). We need to study up on our meds and know our bodies. There is never going to be a miracle cure. Our whole body is damaged goods. We need an overhaul and we must be attuned to subtle changes and allow that small improvement lead to another.

    24 months ago

  • Michelle

    I totally agree Lynette.  The combo I am on now has helped me more than anything I've ever had and my dr worked with me to get there.  I am on gabapentin instead of Lyrica and it works much better for me.  Everyone's body is different and we all need to remember that too.

    Hugs,
    SHELL

    24 months ago

  • Misty

    I read this same article the other day. I am so ticked about it, because I take both Lyrica and Cymbalta. Without them, I cannot move and I swell so bad. I know they both can be very dangerous to my system, but for me the risks far outway the consequences of not taking them.

    Lynette, you are right about the drug company reps. Over the summer I decided to try Savella because I know a few people who have had great success with it, but the side effects I had were the worse ones there are and I decided to never take it again. Now, flash forward to Thursday, I went to the doctor and she said she spoke with the drug rep about my experience and the drug rep told her it was because she started me at the lower dose and she needed to start me at one of the highest doses. My thoughts were, "man, if I was jacked up at lower doses, imagine what a higher dose would do to me." Needless to say, I didn't start Savella again Thursday. We doubled the Cymbalta, which may be helping, but I am so sleepy I will have to tell you next week! hehe! :0)

    I think this is the time we all need to stand up for what we know works for us. I cannot imagine my life without these drugs! :0)

    24 months ago

  • Misty

    Here is a link to the petition to get it removed from the market. This is off of the Public Citizen website!

    http://www.citizen.org/publications/release.cfm?ID=7723

    24 months ago

  • Michelle

    I wish that Cymbalta had worked for me.  I was on it for over a year, worked up to the highest dose and I couldn't tell I was taking it and when I quit it, I couldn't tell I had quit it.  Some meds I have thought weren't helping and then when I went off of them I was like, oh no they were helping after all.  But not Cymbalta.

    Lyrica, I just couldn't take the side effects.  And I haven't tried Savella because I am on a regime that is working for me right now and I have been on it over a year with some tweaking here and there.

    They need to do more testing, and they need to take each individual case by case.  Everyone's body responds different and what helps me might not help you and vice versa.  And they also need to quit using their drug reps like drug dealers.

    SHELL

    24 months ago

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