FDA Gives Milnacipran Green Light for Fibromyalgia Treatment – Third to Be Approved, After Lyrica and Cymbalta

I'm very excited about this approval. With this
medicine's ten year history overseas I think it may
be a better first choice than Cymbalta. Call it
a hunch, I also believe this may be better
suited for those of us with autonomic
dysfunction as well. More thoughts later.
-Ann Enigma

January 15, 2009

The drug milnacipran (to be marketed under the brand name Savella™) received FDA approval as a prescription treatment for symptoms of fibromyalgia (FM) on January 14, 2009 – and reportedly will be available in U.S. pharmacies by March.

Milnacipran – a selective serotonin and norepinephrine dual reuptake inhibitor (SSNRI) developed as an antidepressant – has been tested in multiple trials for ability to demonstrate concurrent improvement in FM pain, physical function, and overall impression of change (global assessment).

Trials Measured “Global” Symptom Status
Generally, more trial subjects taking milnacipran than subjects taking placebo reported “at least a 30% reduction in pain from baseline and also rated themselves as ‘very much improved’ or ‘much improved’ in the global assessment,” according to a release by the drug’s developer, Cypress Bioscience (San Diego), and Forest Labs (New York), which owns the rights to milnacipran in the U.S. and Canada.

Milnacipran “is the only product approved for the management of fibromyalgia that used this complete responder analysis as its primary endpoint,” observes Cypress Bioscience CEO Jay D. Kranzler, MD, PhD.

“The introduction of Savella is important because it is the first drug approved to treat the symptoms of fibromyalgia using a composite responder analysis,” notes fibromyalgia pain specialist and researcher Dr. Daniel Clauw, Professor of Anesthesiology and Medicine (Rheumatology) at the University of Michigan, Ann Arbor.

May Address “Abnormalities in Certain Brain Neurotransmitters”
“Although the exact mechanism by which Savella improves the symptoms of Fibromyalgia is unknown, some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia," the news release states. "Savella blocks the reuptake of both norepinephrine and serotonin, with greater selectivity for the inhibition of norepinephrine reuptake in vitro. This may be the mechanism by which Savella acts to improve the symptoms of fibromyalgia.”

As with all potent drugs, milnacipran is not without potential side effects and contra-indications, as detailed in the Cypress Bioscience/Forest Labs news release under “Important Safety Information.”

Copyright © 2009 ProHealth, Inc.

"Gulf War Syndrome" is real, report finds

It's astonishing to me how long it's taken for illnesses like these to be
legitimized. I suppose I will just try to content myself with the
fact they have been and not concentrate on the suffering
and ridicule that victims of Enigmatic Illness have faced.
Remember only half this battle has been won,
the other half is finding adequate care.

-AnnEnigma

By Andy Sullivan Andy Sullivan

WASHINGTON (Reuters) – A report released Monday concluded that "Gulf War Syndrome" is a legitimate condition suffered by more than 175,000 U.S. war veterans who were exposed to chemical toxins in the 1991 Gulf War.

The congressionally mandated report could help veterans who have battled the government for treatment of a wide range of unexplained neurological illnesses, from brain cancer to multiple sclerosis.

The Research Advisory Committee on Gulf War Veterans' Illnesses concluded that Gulf War Syndrome is a physical condition distinct from the mental "shell shock" suffered by veterans in other wars. Some earlier studies had concluded it was not a distinct illness.

"Scientific evidence leaves no question that Gulf War illness is a real condition with real causes and serious consequences for affected veterans," said the committee, which has been looking into the problem since 2002.

The committee, composed of independent scientists and veterans, said Congress should boost funding for research on Gulf War veterans' health to at least $60 million per year.

"This is a national obligation, made especially urgent by the many years that Gulf War veterans have waited for answers and assistance," the committee said.

Congress set up the committee in 1998, but the U.S. Veterans Administration did not appoint anyone to serve on it until 2002.

Gulf War Syndrome affects at least one-fourth of the 700,000 U.S. troops who served in the 1991 effort to drive Iraq out of Kuwait, or between 175,000 and 210,000 veterans in all, the report found. Few have seen their symptoms improve over the past 17 years, the report said.

Symptoms include persistent headaches, widespread pain, cognitive difficulties, unexplained fatigue, skin rashes, chronic diarrhea and digestive and respiratory problems.

Many Gulf War veterans suffering these symptoms say they met with skepticism when seeking treatment.

The panel found two possible causes: a drug given to troops to protect against nerve gas, known as pyridostigmine bromide, and pesticides that were used heavily during the war.

The panel said other possible causes could not be ruled out, including extensive exposure to smoke from oil-well fires and low-level exposure to sarin gas when captured Iraqi stocks were destroyed.

The U.S. government has spent roughly $440 million on Gulf War health research since 1994, but spending has declined in recent years and often is not focused on improving veterans' health, the committee said.

The report further highlighted inadequacies in the medical care veterans have received from their government.

A 2007 investigation by the Washington Post found combat veterans in the current Iraq war faced rodent-infested housing and bureaucratic hurdles as they sought treatment at the Walter Reed Army Medical Center, the flagship military hospital in Washington D.C..

(Editing by David Storey)

Copyright © 2008 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Copyright © 2008 Yahoo! Inc. All rights reserved.

Fibromyalgia a ‘Real Disease,’ Study Shows

Researchers Say People With Fibromyalgia Have Abnormalities of Blood Flow in the Brain

By Caroline Wilbert
WebMD Health News

Reviewed by Louise Chang, MD

Nov. 3, 2008 -- A new brain scan study concludes that fibromyalgia is related to abnormalities of blood flow in the brain.

"Fibromyalgia may be related to a global dysfunction of cerebral pain-processing," study author Eric Guedj, MD, of Centre Hospitalo-Universitaire de la Timone, in Marseille, France, says in a news release. "This study demonstrates that these patients exhibit modifications of brain perfusion not found in healthy subjects and reinforces the idea that fibromyalgia is a 'real disease/disorder.'"

Fibromyalgia is a chronic disorder characterized by widespread muscle pain and fatigue. It affects 2%-4% of people, mostly women. It has been called the "invisible syndrome" because it can't be diagnosed based on a lab test or X-ray.

For this study, researchers took brain scans on 20 women with fibromyalgia and 10 women without the condition. Participants also answered questions to assess measures of pain, disability, anxiety, and depression.

The brain imaging technique, called single photon emission computed tomography (SPECT), is able to detect functional abnormalities in the brain.

Past imaging studies of patients with fibromyalgia had shown abnormalities in cerebral blood flow, also called brain perfusion. In some areas of the brain, blood flow was below normal, and in some areas, it was above normal. In this study, by using whole-brain scans on the participants, researchers were able to analyze how perfusion in each area of the brain related to measures of pain, disability, anxiety, and depression.

Researchers confirmed that patients with fibromyalgia exhibited brain perfusion abnormalities in comparison to the healthy participants. These abnormalities corresponded with the severity of the disease. An increase in blood flow was found in areas of the brain involved in sensing pain and a decrease was found within an area thought to be involved in emotional responses to pain.

There seemed to be no relationship between these abnormalities and presence of depression or anxiety. "We found that these functional abnormalities were independent of anxiety and depression status," Guedj says in a news release.

SOURCES:
Guedj, E. Journal of Nuclear Medicine, 2008; vol 49: pp 1798-1803.
News release, Society of Nuclear Medicine.
American College of Rheumatology web site.
© 2008 WebMD, LLC. All rights reserved.

a song of CFS and invisible illness

in a recent comment cinderkeys let me know about a song she'd written. i was quite touched by the depth of the emotion conveyed about the everyday of invisible illness, CFS in particular. With her permission... here are the lyrics (link to her myspace and the song below):

Copyright 2006 Susan Wenger
Band name: Cinder Bridge

EVERYBODY KNOWS ABOUT ME

Here I am again
Sitting by the window
In my small apartment on the second floor
Keep myself occupied
By looking at the traffic
As if I've lost the right to ask for more

My body feels like it's
Moving underwater
As I lift a cup of coffee to my face
I think about the things
I'd like to try and do today
But somewhere in the middle lose my place

Thick fog hazy brown
The two-ton weights that pull me down
They don't exist if no one else can see
Everybody knows about
The failings of the down and out
And everybody knows about me

I had a good job had some good friends
Had a life I could look forward to
When I woke up each day
And then the fog rolled in
Consumed them one by one
'til there was nothing left for it to take away

Sometimes I count it as a victory
When I manage
Just to drag my aching body out of bed
The doctors, mystified
Could not produce an answer
So they told me it was all in my head

'cause if I wanted to
I could shake this yuppie flu
Straighten out and set myself free
Anyone can clearly see
We all choose our own destiny
And everybody knows about me

Does it make it easier for you
To think there must be something I could do
Rise like a phoenix from the ashes of this solitary world

So I remain here
Sitting by the window
Watching all the people with their lives to live
I would give anything
To go outside and join them
But today I don't have anything to give

And still they have no doubt
I'm looking for an easy out
And this is what I wanted secretly
Everyone will have their say
They shake their heads
They walk away
And everybody knows about me
Everybody knows about me
Everybody knows about me


To take a listen head to myspace.com/cinderbridge

(If it doesn't start playing immediately, click the "Everybody Knows About Me" link.)

In Susan's own words, "My aim in writing "Everybody Knows About Me" was twofold. First, I wanted people with CFIDS or similar invisible illnesses to feel they weren't alone -- that not everyone believes it's just hypochondria or laziness. Second, I wanted to make nonsufferers understand why it's silly to believe that CFIDS/other invisible illnesses are just hypochondria or laziness."

Epilepsy Drugs to Get Suicide Warnings, FDA Confirms

so many of these drugs are used off label to treat "pain conditions" and other "enigmatic illnesses" so i'm posting this here - AnnEnigma

From newsinferno.com
Date Published: Friday, June 6th, 2008

US regulators are very close to finalizing new suicide warnings for 11 epilepsy drugs, The Wall Street Journal reported today. This past January, the Food & Drug Administration (FDA) issued an Early Communication announcing a safety review of the epilepsy drugs after a study showed they increased patients’ risk of suicidal thoughts and behavior.

The 11 epilepsy drugs slated for a new suicide warning are:

• Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
• Felbamate (marketed as Felbatol)
• Gabapentin (marketed as Neurontin)
• Lamotrigine (marketed as Lamictal)
• Levetiracetam (marketed as Keppra)
• Oxcarbazepine (marketed as Trileptal)
• Pregabalin (marketed as Lyrica)
• Tiagabine (marketed as Gabitril)
• Topiramate (marketed as Topamax)
• Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
• Zonisamide (marketed as Zonegran)

In addition to treating epilepsy, the anti-seizure medications are used for a variety of other illnesses, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide.

The FDA began investigating if epilepsy drugs posed any suicide risk in 2005. In doing so, the FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades. The studies tracked almost 28,000 people given epilepsy medications and another 16,000 given dummy pills.

According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers. The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups. For every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.

In an interview with The Wall Street Journal, Russell Katz, director the FDA’s neuropharmacological drug division confirmed the suicide warnings are coming. “We are working on the labeling changes that we want to get to the companies,” he said. An FDA advisory panel is slated to take up the issue of epilepsy drugs and suicide on July 10, but the Journal speculated the new warnings could come even sooner than that.

At least one drug maker, Pfizer Inc., is less than pleased at this development. Pfizer disputed the FDA’s analysis in a forum this week sponsored by the Epilepsy Study Consortium in New York. Pfizer especially disputes the inclusion of Lyrica - one of the company’s biggest growth drivers -on the FDA’s warning list. Pfizer said that Lyrica accounted for only 6.3% of the total 142 suicidal events cited by the FDA analysis. But the FDA is sticking to its guns, and the new suicide warning will apply to all 11 epilepsy drugs.

Most other epilepsy drug makers are resigned to the label changes, according to the Journal. GlaxoSmithKline, the maker of Lamictal, approached the FDA this year to volunteer changes regarding possible suicidal-behavior risks. Other drug makers may have chosen not to challenge the FDA on suicide warnings because their medications are no longer as lucrative as they once were, as patents on many epilepsy drugs have, or are close to, expiring.

A handy response to all the unsolicited "helpful suggestions"

'Seven genetic types of ME' found

Geneticists have identified a biological basis for seven different subtypes of chronic fatigue syndrome.

The researchers from St George's Hospital, University of London, hope the work could lead to a blood test to distinguish between the forms.

Campaigners hope it will help counter the opinion, which remains in some quarters of the medical profession, that it is a psychological condition.

The research findings are to be presented to a conference in Cambridge.

It's a hard illness to get a handle on, so a clinical test would be the single best way forward for everyone Neil Abbot, ME Research UK

Chronic fatigue syndrome (CFS), also known as ME, is a condition with a diverse range of symptoms but particularly characterised by profound muscle fatigue after physical exertion.

In its most extreme form, CFS/ME leaves sufferers bed-ridden. There is currently no diagnostic test or cure.

It affects around one in 200 people.

'Biologically meaningful'

The St George's study looked at 55 patients from the US and UK with the condition, and carried out a genetic analysis of them and 75 healthy blood donors.

It identified the seven distinct subtypes of CFS/ME identified by a specific genetic pattern.

These were linked to specific symptoms.

Type one had the worst anxiety and depression levels, along with poor sleep and high pain levels.

Type two was characterised by significant post-exercise fatigue and joint and muscle pains, while type three was the mildest form of the disease.

The research identified type four as linked to moderate levels of body pain and sleep problems, with type five having stomach complaints and the most marked muscle weakness.

Type six was specifically connected to fatigue, and type seven had the most severe symptoms including pain, swollen glands and headaches.

Type four and type six were the most common forms of the condition.

Dr Jonathan Kerr, who led the St George's research, said: "We must now determine what these sub-types represent, as they appear to be biologically meaningful, and discover their natural history and possibilities for treatment."

Neil Abbot, of ME Research UK, which is organising the conference along with the Irish ME Trust, said: "The discovery of a 'thumb-print' for the illness would be the single greatest advance that could be made because, at the moment, diagnosis is on the basis of a set of vague symptoms association with other illnesses.

"It's a hard illness to get a handle on, so a clinical test would be the single best way forward for everyone."

Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/7378440.stm

Published: 2008/05/05 23:02:16 GMT

© BBC MMVIII