Savella challenged by Public Citizen

Discussion in 'Fibromyalgia Main Forum' started by richvank, Jan 21, 2010.

  1. richvank

    richvank New Member

    The following was posted on Co-Cure today:

    Source: Dow Jones NewsWires
    Date: January 21, 2010
    Author: Kathy Shwiff
    URL: =20

    FDA urged to end sales of Forest Labs' Fibromyalgia drug

    A nonprofit group urged the Food and Drug Administration to take
    the fibromyalgia drug Savella off the market immediately, saying
    its dangers outweigh its benefits.

    Savella, introduced by Forest Laboratories Inc. (FRX) and Cypress
    Bioscience Inc. (CYPB) last spring, "produces only a marginal effect
    on pain" but has the potential "to be quite dangerous," Public
    Citizen said in a petition Wednesday.

    In Forest's latest quarter, Savella had sales of $15.4 million, up
    50% from the prior quarter. The drug competes with Pfizer Inc.'s
    (PFE) Lyrica.

    As part of its argument, Public Citizen noted that European
    regulators in July rejected Savella, saying its benefits were
    "marginal" and "did not outweigh its risks." The FDA approved the
    drug a year ago to treat fibromyalgia, a chronic condition
    characterized by widespread pain and decreased physical function.

    Public Citizen also highlighted Savella's side effects in its
    letter to the FDA. Trials found the drug increased increase blood
    pressure, heart rate and suicidal thoughts, the group said. The
    rate of those having normal blood pressure at the beginning of the
    study and developing hypertension after taking Savella was triple
    that of patients which received placebo.

    Forest Labs had no immediate comment. Its stock was down 11 cents
    at $31.66 amid a broad market selloff while Cypress fell 4% to

    (c) 2010 Dow Jones & Company, Inc.
  2. KerryK

    KerryK Member

    As an FMS sufferer, I feel we need all possible treatment options. Just as many other diseases have multiple medication options, so should FM. That there are potentially serious side effects is not unique to Savella. That only a minority of patients are significantly helped is also not unique. We are all a little different as patients. I fear this thing could just turn into another round of "Big Pharma" bashing to our own detriment.
  3. hensue

    hensue New Member

    Sorry guys out there that take viagra and need it. It can cause you to go blind?

    They would never pull it.

    The fear is there about Big Pharma
  4. cynicaldog

    cynicaldog New Member

    If the FDA did pull Savella (which I doubt they'll do), you can easily buy it from Europe or Canada. I tried Savella years ago, purchasing it without a prescription, from France and Ireland (it was called "Ixel"). It didn't work for me, but even with shipping costs it was much less expensive than Savella costs me in the US! If you have a prescription, you can buy it from, even if it's not available in the US. That's how I get my reboxetine.
  5. hensue

    hensue New Member

    If you dont mind me asking what is reboxeitne?
    That is good to know.
  6. KerryK

    KerryK Member

    Reboxetine is another norepinephrine agonist. I believe it is used for ADD and is also an anti-depressant. Being a norepinephrine agonist, it will have many of the same side effects of Savella.
  7. quanked

    quanked Member

    "...As part of its argument, Public Citizen noted that European
    regulators in July rejected Savella, saying its benefits were
    "marginal" and "did not outweigh its risks."

    Apparently cannot get it in EUROPE.
  8. pumkinhead

    pumkinhead New Member

    It did not help me. I had horrible side effects. Anxiety level was extremly high. Thought i would lose my mind. Went back to Cymbalta which works the best for me.

    We are all so different it works for some i guess.
  9. gapsych

    gapsych New Member

    I am not familiar with "Public Citizen" so don't have a sense what their mission statement is. Have they cited any studies?

    Someone said they could not get Provigil but don't remember the circumstances. Sometimes insurance will cover it if your doctor writes a letter or are diagnosed with excessive daytime fatigue, which really does not even begin to explain our exhaustion.

    I am now on Nuvigil and I like it better than Provigil. We can't get the generic Provigil here so I assume the same holds for Nuvigil?

    If something is not approved by the FDA, is there a system in place like in Canada where you can get a medication, probably by jumping through hoops? That sounds like a reasonable program. Aussie, do you have to sign something that states you know the risks of this drug.

    I think a lot of us will be watching this closely.

  10. cynicaldog

    cynicaldog New Member

    I just wanted to reply to the comments which say that reboxetine isn't available in Canada. It's been sold in Canada since at least 2004 under the name "Edronax" (I found someone on another forum who was in the Canadian clinical trials for it in 2001, and I know it was available under the "Special Access Program of the Therapeutic Products Programme Branch of Health Canada" as of 2002). I even took a prescription for it to Shopper's Drug Mart in Belleville in 2008 and they wouldn't fill it only because it was a foreign prescription, not because they didn't stock it.

    Anyway, that's why I use my US prescription to order it from CanadaDrugs, which is based in Winnipeg. Reboxetine has been approved for use in over 50 countries (brand names include Edronax®, Norebox®, Prolift®, Solvex® and Vestra®), but in the US, the closest you can get to it is Strattera.