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Author Topic: Medications For Fibromyalgia  (Read 19201 times)
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« on: February 01, 2006, 02:33:48 pm »


Devin Starlanyl On Medications For Fibromyalgia
by Devin Starlanyl

Often, you may have to try many medications before you find the optimum ones for you. We react differently to each medication, and there is no "cookbook recipe" for FMS (fibromylagia syndrome) or MPS (myofascial pain syndrome). What works well for one of us can be ineffective for another. A medication which puts one person to sleep may keep another awake. Each of us has our unique combination of neurotransmitter disruption and connective tissue disturbance. We need doctors who are willing to stick with us until an acceptable symptom relief level is reached.
These are not the only medications in use for FMS & MPS, but are simply a selection to show what is available. It may be necessary to address each perpetuating factor, such as pain, lack of restorative sleep, and muscle rigidity, separately.

Medications should be used along with a program of proper diet, life style changes, mind work and bodywork. Medications which affect the central nervous system are appropriate for FMS&MPS Complex. They target symptoms of sleep lack, muscle rigidity, pain and fatigue. Pain sensations are amplified by FMS, and so the pain of MPS pain is multiplied. FMS&MPS Complex patients often react oddly to medications.

It is the rule rather than the exception that a FMS&MPS Complex patient will save strong pain meds from surgery or injury for when they REALLY need it -- for an FMS&MPS Complex "flare". This is a sign that your needs aren't being met. I give you the following quotes. I hope you will pass them on to your doctor. They are from "PAIN A Clinical Manual for Nursing Practice", by McCaffrey and Beebe.

Health professionals "often are unaware of their lack of knowledge about pain control."

"The health team's reaction to a patient with chronic nonmalignant pain may present an impossible dilemma for the patient. If the patient expresses his depression, the health team may believe the pain is psychogenic or is largely an emotional problem. If the patient tries to hide the depression by being cheerful, the health team may not believe that pain is a significant problem."

"Research shows that, unfortunately, as pain continues through the years, the patient's own internal narcotics, endorphins, decrease and the patient perceives even greater pain from the same stimuli.

"The person with pain is the only authority about the existence and nature of that pain, since the sensation of pain can be felt only by the person who has it."

"Having an emotional reaction to pain does not mean that pain is caused by an emotional problem."

"Pain tolerance is the individual's unique response, varying between patients and varying in the same patient from one situation to another." "Respect for the patient's pain tolerance is crucial for adequate pain contol"

"THERE IS NOT A SHRED OF EVIDENCE ANYWHERE TO JUSTIFY USING A PLACEBO TO DIAGNOSE MALINGERING OR PSYCHOGENIC PAIN."

 "No evidence supports fear of addiction as a reason for withholding narcotics when they are indicated for pain relief. All studies show that regardless of doses or length of time on narcotics, the incidence of addiction is less than 1%."

This book is so clear and so well documented that I suggested my local library buy it. I wanted everyone in the area to have access to this information. Once you read this book, you get a greater understanding of pain and pain medications, as well as coping mechanisms. Many non-pharmaceutical methods of pain control are also described thoroughly in this reference.

It's normal to be depressed with chronic pain, but that doesn't mean depression is causing the pain. Maintenance with mild narcotics (Darvocet, Tylenol #3, Vicodin-Lorcet-Lortab) for nonmalignant (non-cancerous) chronic pain conditions be a humane alternative if other reasonable attempts at pain control have failed. The main problem with raised dosages of these medications is not with the narcotic components, per se, but with the aspirin or acetaminophen that is often compounded with them. For medical journal documentation on the use of narcotics for non-malignant chronic pain, see "The Fibromyalgia Advocate". Narcotics should not be given in conjunction with benzodiazepines, as the latter antagonize opioid analgesia.

Narcotic analgesics are sometimes more easily tolerated than NSAIDS, the Non-Steroidal Anti-Inflammatory Drugs. Neither FMS nor MPS is inflammatory. NSAIDS may disrupt stage 4 sleep. Prolonged use of narcotics may result in physiological changes of tolerance or physical dependence (with- drawal), but these are not the same as psychological dependence (addiction). Under-treatment of chronic pain of MPS/FMS results in a worsening contraction which results in even more pain. "Anti- anxiety" medications are not an indication that your symptoms are "all in the head". These medications don't stop the alpha-wave intrusion into delta-level sleep, but they extend quantity of sleep, and may ease daytime symptom "flares".

Folic acid: This vitamin is often in short supply in FMS & MPS. Drs. Travell and Simons found it especially effective for Restless Leg Syndrome.

Relafen (nambumetone):This is a NSAID that is often well tolerated because it is absorbed in the intestine, sparing the stomach.

Benedryl (dyphenhydramine):a helpful sleep aid/antihistamine which is safe in pregnancy. This should be the first sleep medication tried. Some patients have reported urinary retention. The starting dose is 50 mg 1 hr. before bed. Increase as tolerated until symptoms are controlled or 300 mgs. About 20% of patients react with excitation rather than sedation when taking Benadryl. (non-prescription)

Desyrel (Trazodone): an antidepressant that helps with sleep problems. It must be taken with food.

Atarax (hydroxyzine HCl): suppresses activity in some areas of Central Nervous System to produce an anti-anxiety effect. This antihistamine and anxiety-reliever may be useful when itching is a problem. Elavil (amitriptyline): a tricyclic antidepressant (TCA) is cheap and sometimes useful. It generates a deep stage four sleep. Most patients will adapt to this med after a few weeks. It can cause photosensitivity and morning grogginess. It often causes weight gain, dry mouth, as well as stopping the normal movements of the intestine. It may cause Restless Leg Syndrome.

Wellbutrin (bupropion HCl): is a weak Specific Serotonin Reuptake Inhibitor (SSRI) and antidepressant that is sometimes used in FMS & MPS Complex in place of Elavil. It can promote seizures. It seems to be less likely to promote sexual dysfunction than the most SSRIs.

Ambien (zolpidem tartate): hypnotic -- sleeping pill, for short-term use for insomnia. There have been reports of serious depression, but some people with FMS find it allows them to experience restorative sleep.

Soma (carisoprodol): acts on Central Nervous System to relax muscles, not on the muscles themselves. It works rapidly and lasts from 4 to 6 hrs. It helps detach from pain, and modulates erratic neurotransmitter traffic, damping the sensory overload of FMS and muscular rigidity of MPS.

Flexeril (cyclobensaprine): this medication can sometimes stop spasms, twitches and some tightness of the muscle. It is related chemically to Elavil. It generates stage four sleep, but it may cause gastric upset and a feeling of detachment from life. Sinequan (doxepin): heterotricyclic antidepressant and antihistamine. It can produce marked sedation. This medication may enhance Klonopin, but can reduce muscle twitching by itself.

Prozac (fluoxetine hydrochloride): anti-depressant that increases the availability of serotonin, useful for those patients who sleep excessively, have severe depression and overwhelming fatigue. Some people have reported profound depression from Prozac.

Ultram (tramadol): non-narcotic, Central Nervous System medication for moderate to severe pain, in a new class of analgesics called CABAs -- Centrally Acting Binary Agents. Many people said it brought more alertness for longer times, and less "fibrofumble" of the fingers. It can lower the seizure threshold. Side-effects reported are grogginess, insomnia (may not be able to take at night), headache or loss of sex drive. Some people have reported profound depression resulting from Ultram.

Hydrocodone/Guaifenisen Syrup: This medication is generally given as a cough suppressant. Each teaspoon contains 5 mg. Hydrocodone and 100 mg Guaifenisen. It has no aspirin or ibuprofen. It may be effective for pain medication, and can be "titrated" because it is in syrup form. The patient can take very small amounts and can find the amount which works without causing undue side effects."

Xanax (alprazolam):an anti-anxiety medication, that may be enhanced by ibuprofen. It must not be used in pregnancy. It enhances the formation of blood platelets, which store serotonin, and also raises the seizure threshold. When stopping this medication, you must taper it very gradually. EMLA: a prescription only topical cream, that may help cutaneous TrPs. It is a mixture of topical anesthetics.

Pamelor (nortriptyline):this is used to help sleep. Some people find it stimulating, and must take it in the morning. Others use it before bed to help sleep. Some reports of depression with use.

Klonopin (clonazepam): anti-anxiety medication and anticonvulsive/ antispasmodic. It is useful in dealing with muscle twitching, Restless Leg Syndrome and nighttime grinding of teeth.

BuSpar (buspirone HCl): may improve memory, reduce anxiety, helps regulate body temperature, and is not as sedating as many other anti-anxiety drugs. This medication often takes a few weeks to take effect.

Zoloft (sertraline):this is an SSRI and antidepressant, and is commonly used to help sleep. It has less of an effect on liver enzymes than other SSRIs.

Tagamet, Zantac, Prilosec, Axid: often used to counter esophageal reflux. Tagamet may increase stage 4 sleep, and enhance Elavil. Acid suppressors may interfere with B-12 absorption.

Paxil (paroxetine HCl):serotonin and norepinephrine reuptake inhibitor, and may reduce pain. It should not be used with other meds that also increase brain serotonin. Suggested dosage is 10 mgs (half a scored tablet) may cause insomnia or drowsiness.

Effexor (venlafaxine HCl):Fast acting antidepressant and serotonin and norepinephrine reuptake inhibitor. Suggested trial dosage is 25 mg, taken in the morning. Food has no affect on its absorption. When discontinuing this medication, taper off slowly. May raise blood pressure.

Inderal (propranolol HCl):sometimes helps in the prevention of migraine headaches, although blood pressure may drop with its use. Antacids will block its effect, and should not be used. May be very useful in decreasing "adrenalin rush".

Librax: for Irritable Bowel Syndrome. It is a combination of antispasmodic plus tranquilizer, that helps modulate bowel action.

Diflucan (fluconazole): this antifungal penetrates all of the body's tissues, even the central nervous system. Very short term use can be considered if cognitive problems and/or depression is present, and yeast is suspected. Yeast may also be at the root of irritable bowel, sleep dysfunction (muramyl dipeptides from bowel bacteria induce sleep), and other common FMS problems.

Imitrex (sumatriptan): this is available as an injectable solution or pill that will not prevent migraines, but it is effective for migraine pain in many cases. Works on serotonin release instead of blood vessel spasm, and may provide relief in less than 20 minutes. It should not be used within 24 hours of ergot (a common migraine drug) medications. It can increase blood pressure. It may cause spasm of muscles in jaw, neck, shoulders and arms. Also reported were tingling sensations, rapid heartbeat and the "shakes". Frequent use of Imitrex may cause a rebound reaction, worsening migraines.

Remeron (mirtazapine): tetracyclic antidepressant, which effects several neurotransmitters, including serotonin and norepinephrine. May cause drowsiness and/or weight gain. Reported increase in cholesterol with some patients.

Zanaflex (tizanidine): is a relatively new medication for muscle tightness and pain. It also reduces muscle spasm frequency and myoclonus. Effective dosage varies considerably in patients. May cause drowsiness."

COX-2 inhibitors:These medications will be out shortly. They block cyclooxygenase-2, an enzyme that helps create enormous mounts of prostaglandins. they not only seem to be effective for inflammation (FMS & MPS are not inflammatory), but they may be a promising alternative to narcotics for pain relief.
 

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« Last Edit: February 21, 2009, 12:56:35 pm by Adminஐﻬ » Logged


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« Reply #1 on: December 31, 2007, 11:24:23 pm »

December 31, 2007 

Forest Laboratories Inc.  and Cypress Bioscience Inc.  have recently submitted a New Drug Application to the U.S. Food and Drug Administration for milnacipran, a unique dual-reuptake inhibitor being developed for the treatment of fibromyalgia syndrome.

FMS is defined by widespread chronic pain, as well as a broad spectrum of related symptoms including fatigue, cognitive dysfunction, and reduced physical function. The NDA for milnacipran is based on a composite responder analysis that requires each patient to experience concurrent and clinically meaningful improvements in three validated measures: pain, patient global impression of change in disease status, and physical function.

The submission includes efficacy data from two pivotal phase three trials involving 2,084 patients, which showed that milnacipran demonstrated improvement compared to placebo in treating FMS. Moreover, safety data collected from 2,209 patients during the development program demonstrated that milnacipran was generally well tolerated with the majority of adverse events reported as mild to moderate in nature.
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« Reply #2 on: February 21, 2009, 11:25:26 am »

New drug, Savella, brings hope for fibromyalgia patients

February 21, 2009

Hard to define and even harder to treat, fibromyalgia has become one of the most controversial medical conditions of the past quarter-century. Affecting an estimated 5.8 million Americans, it has been recognized as a disease by the American Medical Association since 1987. But because its most significant symptoms are pain and fatigue, with no obvious cause, FM patients — most of whom are women — can sometimes find that they're not taken seriously even by some medical professionals.

St. Petersburg geriatrician and fibromyalgia expert Dr. Mildred Farmer says there's new hope on the horizon for FM sufferers. Meridien Research, the company she co-founded in 1990, was one of the institutions that tested the efficacy and safety of a new fibromyalgia medication called Savella that was recently approved by the FDA and should be on the market later this year. It's just the third anti-FM medication approved by the FDA, following Cymbalta and Lyrica.

Savella is already being prescribed in Europe as an antidepressant, but Meridien Research and other test sites across the country were looking at how it could help FM sufferers by affecting norepinephrine, a central nervous system neurotransmitter.

Neither Farmer nor her company has a financial interest in Savella or the company that makes it, Cypress Bioscience.

ஐﻬ What is fibromyalgia?

Essentially, it's a collection of symptoms, a pain syndrome that is otherwise non-specific. Some people have aches and pains and not much fatigue, and some people have mostly the chronic fatigue and not as much pain. It could spring from a variety of causes.

ஐﻬ How can you diagnose something that's so elusive?

You must have widespread pain, in all four quadrants of the body, and it must be chronic. It's characterized by the presence of trigger points. When you press on one of these points, they cause pain. It's the presence of these trigger points and widespread pain, and the absence of joint and muscle pain, that makes fibromyalgia. It can be very subtle, and you might not even know you have it.

ஐﻬ Who's most likely to suffer from fibromyalgia?

It's more common in women than men, and nobody knows why. I've read estimates that the ratio is 9 to 1. I wouldn't be able to verify that, but it's in that ballpark. Most of my fibromyalgia patients had a pain incident that preceded it — a car accident, a blow to the head. My usual patient is someone who has had back surgery. There's also a genetic component, but it's not just one gene, it's a combination of genes.

ஐﻬ How has it traditionally been treated?

What's been happening for a long time is that rheumatologists have been treating fibromyalgia as a muscular-skeletal condition, and now it's recognized as neuro-muscular. Traditional pain medications don't do much. Non-steroidal anti-inflammatories, muscle relaxants, tricyclic antidepressants and exercise have all been somewhat effective, but different patients respond to different treatments. Even though the antidepressants can work, fibromyalgia is not depression. The patient may feel depressed, because of the chronic pain and because maybe no one believes her, but antidepressants can be effective for fibromyalgia itself.

ஐﻬ Is Savella a dramatic breakthrough or just one more weapon in the arsenal?

In a way it's just one more weapon. But the anti-fibromyalgia arsenal is so incredibly limited that even one additional weapon is significant.

ஐﻬ What's different about Savella?

Savella has more norepinephrine activity, and antidepressants with more norepinephrine activity seem to be more effective in treating pain. But there's not been a head-to-head comparison of Cymbalta and this drug, so we can't say this is better.
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« Reply #3 on: September 12, 2009, 09:10:35 pm »

New Data Show Patients With Chronic Low Back Pain
               

                    Maintained Pain Reduction on Duloxetine                   

   Further Pain Reductionon Duloxetine Shown During Study's Extension Phase 
   



Sept. 09,2009
 New data show patients with chronic low back pain on duloxetine hydrochloride (Cymbalta®) maintained reductions in pain for 41 weeks. In patients who initially responded to duloxetine, this maintenance of pain reduction was accompanied by further reduction in pain that was statistically significant as measured by the Brief Pain Inventory (BPI) average pain rating.1 The data will be presented today at the sixth triennial congress of the European Federation of InternationalAssociation for the Study of Pain Chapters (EFIC®).

A total of 181 patients enrolled in the open-label 41-week extension phase of
the study, designed to evaluate long-term maintenance of effect in patients
with chronic low back pain taking duloxetine 60 mg or 120 mg once daily.
Maintenance of effect was assessed in the responders - 58 duloxetine patients
who had experienced at least 30 percent pain reduction from baseline during the
13-week, placebo-controlled acute phase of the study.

The most common adverse events in the study (those occurring in more than 5
percent of study participants) included headache, nausea, upper abdominal pain,
excessive sweating (hyperhidrosis), back pain, diarrhoea and fatigue. Adverse
events were similar to those seen in previous duloxetine studies.1 A total of
18 patients in the study discontinued due to adverse events during the
extension phase.

"Chronic low back pain is a painful and debilitating condition and this study
is an important step in the fight against it," said Vladimir Skljarevski, M.D.,
lead study author and a neurologist and medical fellow at Lilly Research
Laboratories.

Experts estimate chronic low back pain affects between 4 percent and 33 percent
of the world's population at any one time. According to the International
Association for the Study of Pain (IASP), the pain is an unpleasant sensory and
emotional experience associated with actual or potential tissue damage, or
described in terms of such damage. Chronic pain is defined as pain that
persists beyond acute pain or beyond the expected time for an injury to heal.
Men and women are equally affected by chronic low back pain, and it occurs most
often between the ages of 30 and 50.

In Europe, duloxetine is approved for the treatment of diabetic peripheral
neuropathic pain (DPNP), major depressive disorder (MDD), generalised anxiety
disorder (GAD) and stress urinary incontinence (SUI)

Duloxetine is approved in various countries outside of Europe for the
management of DPNP, for the treatment of MDD, for the treatment of GAD and for
the management of fibromyalgia.
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« Reply #4 on: August 24, 2010, 09:13:32 am »

FDA Worries About Abuse With Jazz Fibromyalgia Drug

 Aug. 19, 2010


WASHINGTON--FDA drug reviewers Wednesday said it was unclear whether Jazz Pharmaceuticals Inc.’s risk evaluation and mitigation strategy (REMS) plan could fully mitigate the risks of misuse, abuse and overdose of its sodium oxybate drug to treat fibromyalgia.

The drug, whose active ingredient is gamma-hydroxybutyrate, or GHB--known as the illicit "date rape" drug--already is sold in another formulation under the brand name Xyrem as a treatment to reduce daytime sleepiness and cataplexy in patients with narcolepsy. But Jazz has proposed selling a lower dose under the name Rekinla for fibromyalgia, which regulators said could lead to dual prescriptions, resulting in overdose or death.

Nonetheless, investors were confident in the drug, driving shares of the Palo Alto, Calif.-based specialty pharma (NASDAQ:JAZZ) up as high as 16 percent Wednesday, before closing at $10.61 , a gain of 36 cents, or 3.5 percent.

In briefing documents released ahead of Friday's joint meeting of the FDA's Arthritis and Drug Safety and Risk Management Advisory Committees, regulators said patients diagnosed with fibromyalgia and narcolepsy could mistakenly be prescribed both Rekinla 375 mg/mL and Xyrem 500 mg/mL by prescribers who fail to recognize that the commercial products each contain sodium oxybate, which could result in overdose and potentially death.

While Jazz argued that the narcolepsy and fibromyalgia patient populations do not overlap, the FDA said the company had failed to provide data to back up that claim. "We remain unconvinced that the narcolepsy patient population and fibromyalgia patient population are mutually exclusive since some patients might be diagnosed with both narcolepsy and fibromyalgia," FDA drug reviewers said.

The agency's scientists said the basis for their concerns for the use of two brand names for sodium oxybate is that "medication errors of this type have been reported with other products that share a common active ingredient, but use different proprietary names."

Jazz has insisted that the elements within the Rekinla and Xyrem REMS programs, which include restricted distribution, mitigate the risk of dual prescribing medication errors.

But regulators said it was not clear from the information provided by Jazz whether the company's claim would prove true.

Jazz spokeswoman Ami Knoefler told BioWorld Today Wednesday that the company planned to continue its pursuit of the two separate trade names for its sodium oxybate drugs.

In contrast to the number of sodium oxybate-treated narcolepsy patients, "a much larger population of fibromyalgia patients is likely to be exposed to sodium oxybate," regulators said.

The FDA reviewers said the distribution restrictions of sodium oxybate-containing products for the various approved indications must take into consideration patient access and the possible increases in the rates of abuse, diversion and misuse including drug-facilitated sexual assault. Regulators noted that in its illicit form, GHB is a Schedule I controlled substance.

Xyrem, however, has been designated a Schedule III controlled substance. The FDA acknowledged that any sodium oxybate-containing product approved for fibromyalgia would be similarly scheduled, whatever name it eventually goes by.

The FDA Friday will ask its panel of arthritis and drug safety experts whether Rekinla's risk-benefit profile favors approval of the drug for fibromyalgia or if more efficacy or safety data are needed, in addition to changes to the proposed REMS.

The agency also wants to hear whether two separate trade names pose a risk for medication errors by having essentially the same drug on the market for different indications.

If approved, Jazz's sodium oxybate drug would be the fourth product approved in the U.S. for the treatment of fibromyalgia, joining Eli Lilly and Co.'s Cymbalta (duloxetine), Forest Laboratories Inc.'s Savella (milnacipran) and Pfizer Inc.'s Lyrica (pregabalin).

The FDA is scheduled to make a decision by Oct. 11.
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