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Jan 15, 2009 03:08 PM | 19
The U.S. Food and Drug Administration (FDA) has approved a new med to treat fibromyalgia, a mysterious disease characterized by chronic widespread pain, fatigue, sleep disturbances and depression.
The agency yesterday gave its nod to Savella (milnacipran HCL), a type of antidepressant known as a dual selective serotonin and norepinephrine reuptake inhibitor (SSNRI), according to drug makers New York City–based Forest Laboratories and Cypress Bioscience in San Diego. SSNRIs work by making it easier for neurons (nerve cells) in the brain to use the neurotransmitters serotonin and norepinephrine to send signals to one another. Both of these neurotransmitters are known to play a key role in regulating pain and mood.
Until now, only two drugs were available for treating fibromyalgia: Cymbalta made by Eli Lilly (an antidepressant and painkiller), and Pfizer's Lyrica, an Rx designed to control seizures and pain. The drugmakers said in a statement that Savella is expected to be available in U.S. pharmacies by March 2009.
According to the American College of Rheumatology, as many as 12 million people in the U.S. (4 percent of the population) suffer from fibromyalgia. The cause of this puzzling ailment is unknown, but scientists suspect genetic factors and chronic stress may be involved.
The FDA nod comes just days after a study appeared in JAMA The Journal of the American Medical Association that found that Savella and several other drugs traditionally used as antidepressants reduced some of the symptoms of fibromyalgia.
Milnacipran is approved for use as an antidepressant (called Ixel and Toledomin) in several European, Asian, and South American countries.
"It's definitely a step in the right direction, but it's not the final answer," says Rae Marie Gleason, Executive Director of the National Fibromyalgia Association, a nonprofit based in Anaheim, Calif. Gleason says that neither Savella, nor the other two drugs currently FDA-approved, work for all patients or eliminate all symptoms. Researchers should continue studying, she says "combination treatments [that integrate medication with exercise and counseling] and other medicines that might come on board."
Image credit ©iStockphoto.com/Victor Prikhodko
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19 Comments
Add CommentJust give us the dam painkillers. You know this crap you call antidepressants DON'T work! GOD, are you people cruel to the point of inhuman! Maybe you're all evil aliens.
Reply | Report Abuse | Link to thisIsn't it true that Fibromyalgia is caused by lack of REM sleep and too much stress? I have been taking trazadone for sleeping aide for years and years. I am way worse without it but it sure doesn't do the trick. I recently had 2 knee replacements and it sent my body into a rage recently. I would like to see the root of the problem solved in stead of masking it with all kinds of drugs that create new problems. Sally of Antioch, CA
Reply | Report Abuse | Link to thisThe problem, zena, is painkillers cost us 4.00 a month or less. These new drugs are more like 180. 00 a month; it isn't about stopping pain, it is about how much money they can make off of us.
Reply | Report Abuse | Link to thisWhat % of fibromyalgia is caused by statins?
Reply | Report Abuse | Link to thisI am trying to withdraw from another SSNRI (took for only 6 months) and am having the most horrible side effects. It is Pristiq which was to replace Prozac that I'd been taking for 10 years (not for depression, but for a lack of energy due to fibromyalgia which 10 years ago wasn't a recognized disease) I'm trying to warn fibromyalgia suffers about what can happen with a SSNRI drug. You might want to check out Effexor withdrawal prior to beginning on this new drug. My SSNRI drug is compatable to Effexor and I'm having the same horrible side effects of withdrawal, worry this new drug will have them also. Fibromyalgia is such a physically and mentally intense disease already without additional suffering. I haven't had any REM sleep in over 11 years (per sleep clinic at Mayo in Rochester, MN) and an antidepressant isn't the answer.
Reply | Report Abuse | Link to thisI don't care what miracle drug comes out of the woodwork, at best only the symptoms will be addressed, not the cause. I am symptom free, and I mean symptom free after 18 years of misery suffering with Fibro. I make no secret that I now work for the doctor that did address the cause. It's because I'm symptom free that I want to help others find what I did. I see it's not permitted to say anymore than I have. I just don't want people to give up hope.
Reply | Report Abuse | Link to thisI am agreeing with ZenaV.
Reply | Report Abuse | Link to thisPeople with pain are commonly assumed to be either present or future drug addicts.
Addiction is an insatiable drive to use a drug because of the pleasure it affords and the side effects of craving that pleasure.
Addiction is very rarely encountered among patients with pain. The pain takes up all the “active ingredients”.
Being pain-free for a time may seem like pleasure, but it is not what recreational drugs users are looking for.
Tolerance is the need to receive increasing doses in order to maintain analgesic effect.
Because of this, people with chronic pain are often accused of drug-seeking behavior as they may come to need more drugs.
When a person is in severe pain and seeks medication that relieves that pain, drug-seeking behavior is normal and understandable. It is not a warning signal of addiction.
Dependence is the development of withdrawal symptoms when the opiate is suddenly discontinued.
Dependence is not a problem as withdrawal symptoms can easily be avoided by making sure that the patient does not run out of medication.
Dependence is not limited to opiates, either. There are many drugs that warn against suddenly discontinuing them.
It is unfortunate that people with pain as so often lumped together with people with addictions.
Some research suggests that many cases of Fibromyalgia are actually misdiagnosed cases of Vitamin D deficiency. I suggest that people take vitamin D supplements or get sufficient sunlight, without sunscreen, to get their vitamin D levels to 55-70 ng/mL as recommended here: http://www.thorne.com/altmedrev/.fulltext/13/1/6.pdf
Reply | Report Abuse | Link to thisThis article gives a false hope to the sufferers. The new drug is still a kind of antidepressant and not very different from the previoulsly used drugs so far to reduce the pain. Also, when talking about the cause of the syndrom, it is said that it can appear follwing a trauma such as a car accident or a major shock or even a prolonged not straight-forward surgery.
Reply | Report Abuse | Link to thisI agree with you. Unless you suffer from fibromyolgea you cannot understand it and asume that you have just find the cure for it. I stopped taking antidepressants. they were turning me into a monster, confused, sleepy, drowsy with blured vision and always angry. In addition, when the pain want to come it will do no matter what you are taking. Nothing seem to be able to take away the pain. drugs only reduce the pain. I find relaxation helps, swimming in worm water ( if I can afford it) physiotherapy and accupunture. I attended a hospital course which included all the above apart from the swimming, and I was feeling great for a few month after that. I am waiting to have the chance to have another course but this seems to be a mere dream.
Reply | Report Abuse | Link to thisLet's look at the big picture here. All the concrete backing exists to show that Substance P is the culprit in our spines over-sending messages to dopamine which end up in exaggerated experiences of physical pain. They also know that capsaicin is an effective blocker. Seems to me that the drug companies, government and doctors by keeping us drugged up and receiving treatments than actually fixing the cerecrospinal fluid problem, Substance P.
Reply | Report Abuse | Link to thisLet's look at the big picture here. All the concrete backing exists to show that Substance P is the culprit in our spines over-sending messages to dopamine which end up in exaggerated experiences of physical pain. They also know that capsaicin is an effective blocker. Seems to me that the drug companies, government and doctors by keeping us drugged up and receiving treatments than actually fixing the cerecrospinal fluid problem, Substance P.
Reply | Report Abuse | Link to thisnever take cymbalta for fibromyalgia or any other condition.It will make any condition worse with permanent lasting after affects.This drug was pushed thru approval with no solid testing.Drug company contributed millions to politicians.It is poison.
Reply | Report Abuse | Link to thiscan you please tell me what you did to become symptomm free form fibromyalgia? I have suffered from this for so many years and would do just about anything to be symptom free, thanks.
Reply | Report Abuse | Link to thiscan you please tell me what you did to become symptomm free form fibromyalgia? I have suffered from this for so many years and would do just about anything to be symptom free, thanks.
Reply | Report Abuse | Link to thishow did your doctor cure your fibromyalgia?
Reply | Report Abuse | Link to thishow did your doctor cure your fibromyalgia?
Reply | Report Abuse | Link to thisI WOULD LOVE TO KNOW WHAT YOU DID TO HELP YOUR FIBROMYALGIA
Reply | Report Abuse | Link to thisHow can I learn more about the cure your doctor provided? Are you still fibromyalgia free? Where are you located? Can you tell us the name of your doctor?
Reply | Report Abuse | Link to thisThanks,
Sally