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FDA Approves Duloxetine (Cymbalta) for Fibromyalgia 6-16-08
INDIANAPOLIS, June 16 -- The FDA has approved duloxetine (Cymbalta), a serotonin-norepinphrine reuptake inhibitor, for fibromyalgia, the drug-maker said today.
The Lilly antidepressant Duloxetine is the second drug to be approved for this indication. A year ago the FDA approved the seizure drug pregabalin (Lyrica) for fibromyalgia.
Duloxetine is also indicated in adults for major depressive disorder, general anxiety, and peripheral diabetic neuropathy.
The added indication was approval on the basis of data from two three-month clinical trials of 874 fibromyalgia patients. In both studies, compared with placebo, duloxetine was associated with more than a 30% reduction in pain as measured by the Brief Pain Inventory (BPI) 24-hour average pain scale.
Moreover, patients randomized to duloxetine reported significant pain relief during the first week of treatment.
In both studies the majority of duloxetine patients -- 65% in one study and 66% in the other -- said they felt better since beginning treatment with 60 mg of duloxetine daily, as measured by a self-assessment (Patient Global Impression of Improvement).
The most commonly reported adverse events were nausea, dry mouth, constipation, decreased appetite, sleepiness, increased sweating, and agitation. Twenty percent of duloxetine patients discontinued the study drug because of adverse events versus 12% of placebo patients.
Duloxetine should not be taken by patients who are using or have recently used a monoamine oxidase inhibitor, patients taking thloridazine (Mellari) or patients with uncontrolled glaucoma. Severe and sometimes fatal liver problems have been reported among patients taking duloxetine. Duloxetine may increase the risk of hemorrhage among patients taking NSAIDs, aspirin, or other blood thinners.
I must again remind reader that this does not cure fibromyalgia just reduce pain if the pain is nerve related and reduce the depression that is of ten the cause of physical pain. As someone who had fibromyalgia before they had a name for it this angers me. It is as if the medical profession is still saying it is all in your head. Fibromyalgia is curable and very few people actually have it, once you figure out what the real problem is it will be gone.
WHAT IS FIBROMYALGIA SYNDROME?
This is what medicine has to conventional medicine has to say!
FMS (Fibromyalgia syndrome) is a widespread musculoskeletal pain and fatigue disorder for which the cause is still unknown. Fibromyalgia means pain in the muscles, ligaments, and tendons “ the soft fibrous tissues in the body.
Most patients with FMS say that they ache all over. Their muscles may feel like they have been pulled or overworked. Sometimes the muscles twitch and at other times they burn. More women than men are afflicted with FMS, and it shows up in people of all ages.
To help your family and friends relate to your condition, have them think back to the last time they had a bad flu. Every muscle in their body shouted out in pain. In addition, they felt devoid of energy as though someone had unplugged their power supply. While the severity of symptoms fluctuate from person to person, FMS may resemble a post-viral state. This similarity is the reason experts in the field of FMS and chronic fatigue syndrome (CFS) believe that these two syndromes may be one and the same. Gulf War syndrome also overlaps with FMS/CFS.
SYMPTOMS AND ASSOCIATED SYNDROMES
Pain - The
pain of FMS has no boundaries. People describe the pain as deep muscular aching,
throbbing, shooting, and stabbing. Intense burning may also be present. Quite
often, the pain and stiffness are worse in the morning and you may hurt more in
muscle groups that are used repetitively.
Fatigue - This symptom can be mild in some patients and yet
incapacitating in others. The fatigue has been described as "brain fatigue" in
which patients feel totally drained of energy. Many patients depict this
situation by saying that they feel as though their arms and legs are tied to
concrete blocks, and they have difficulty concentrating, e.g., brain fog.
Sleep disorder - Most FMS patients have an associated sleep disorder called
the alpha-EEG anomaly. This condition was uncovered in a sleep lab with the aid
of a machine which recorded the brain waves of patients during sleep.
Researchers found that most FMS patients could fall asleep without much trouble,
but their deep level (or stage 4) sleep was constantly interrupted by bursts of
awake-like brain activity. Patients appeared to spend the night with one foot in
sleep and the other one out of it.
Sleep lab tests may not be necessary to determine if you have disturbed sleep.
If you wake up feeling as though you've just been run over by a Mack truck “
what doctors refer to as unrefreshing sleep “ it is reasonable for your
physician to assume that you have a sleep disorder. Many FMS patients have been
found to have other sleep disorders in addition to the alpha-EEG, such as sleep
apnea, sleep myoclonus (nighttime jerking of the arms and legs), and restless
legs syndrome. A newly discovered sleep disorder, upper-airway resistance
syndrome, is also being evaluated for its association with FMS.
Irritable Bowel Syndrome - Constipation, diarrhea, frequent abdominal
pain, abdominal gas, and nausea represent symptoms frequently found in roughly
40 to 70% of FMS patients.
Chronic headaches -
Recurrent migraine or tension-type headaches are seen in about 50% of FMS
patients and can pose a major problem in coping for this patient group.
Temporomandibular Joint Dysfunction Syndrome - This syndrome, sometimes
referred to as TMJ or TMD, causes tremendous jaw-related face and head pain in
one quarter of FMS patients. However, a 1997 published report indicated that
close to 75% of FMS patients have a varying degree of jaw discomfort. Typically,
the problems are related to the muscles and ligaments surrounding the jaw joint
and not necessarily the joint itself.
Other common symptoms - Premenstrual syndrome and painful periods, chest
pain, morning stiffness, cognitive or memory impairment, numbness and tingling
sensations, muscle twitching, irritable bladder, the feeling of swollen
extremities, skin sensitivities, dry eyes and mouth, dizziness, and impaired
coordination can occur. Patients are often sensitive to odors, loud noises,
bright lights, and sometimes even the medications that they are prescribed.
Aggravating factors - Changes in weather, cold or drafty environments,
infections, allergies, hormonal fluctuations (premenstrual and menopausal
states), stress, depression, anxiety and over-exertion may all contribute to
symptom flare-ups.
THE TRUTH:
I have found that the majority of Fibromyalgia is misdiagnosis of another condition. Many people with pain or fatigue that is localized or undiagnosable to their General Practitioner is labeled Fibromyalgia. The following steps were developed by myself through clients and my own personal experience. They have been successful in over 90% of cases. I give this information freely because I have had to deal with the condition for so long! I hope it works well for you.
The steps are designed to rule out any misdiagnosis or underlying conditions that cause these symptoms. Do each step for at least 2 weeks before moving on. Keep progressing to the next step until you are well.
Steps To Fibromyalgia Recovery
Important: Bella Mira Essential Oil Release and Organic Excellence Joint Pain Cream for immediate relief while doing these steps. Visit our PAIN page for great information on all types of pain!
Step 1: Take Candida Questionnaire. If score is high treat with Temple Cleanse 1 capsule Bella Mira Perfect Enzymes on an empty stomach 3 times a day for 14 days, and dietary changes.
Step 2: Have bodily PH tested. If it is acidic (under 7.0) Immediately eliminate all grains ( see gluten free living) reduce animal protein and begin juicing (especially cucumber, black cherry, melons and lemons) Drink half your body weight a day in ounces of distilled water. Continue this diet until PH is in normal range. Then slowly add back protein. And monitor PH and reduce protein as needed.
Step 3: Have your Thyroid levels checked. TSH and Free T3. Take Free Thyroid Function Test!
New guidelines are normal TSH 0.3-3.0!
Step 4:
Step 5:
Step 6: If you have Mercury Amalgam (Silver) Fillings. Get them removed by a Huggins trained Dentist. You are risking your health by having anyone else do it. Make sure you do 2 courses of Life Flo Metal X afterwards.
Step 7: Seek Chiropractic advice to check for postural abnormalities that may be causing pain.
Step 8: Use Bella Mira Essential Oils Spruce or Release 2 drops on the soles of the feet twice daily. You May also have to also take 1 drop twice daily orally (in water or juice).
Step 10: Make sure you are getting enough fiber. You should be "moving" 1-3 times a day. If not start a colon cleanse such as Temple Cleanse. Then add a daily fiber supplement. My favorite is Ground flaxseed 3tbsp day or juice plums or prunes.
Step 11: Get chemical free! Filter of distill water, get shower filter, use natural non chemical soaps, shampoo, household cleaners, laundry products, fluoride free toothpaste, natural room fresheners like essential oils; don’t use plug-ins, carpet fresh or any artificial perfumes; find natural alternatives to pesticides indoors and out, find aluminum free deodorant, nix artificial sweeteners use stevia, stay away from dyes, preservatives
Step 12: Start exercising! I know it’s hard but start with gentle stretching and work up to walking or swimming (Not in Chlorinated pools). You will feel much better.
These are just the basics on the road to good health. Take your time; don’t try to do everything all at once. Remember these are STEPS! If you have ANY questions or need any help please email.
