Advice from BUPA

Treatment of fibromyalgia

At the moment, there is no cure for fibromyalgia. However, there are treatments available to help manage its symptoms. And some simple changes to your lifestyle can help reduce how much the condition affects your daily activities.
Self-help treatments
There are a number of practical things you can do yourself to help control your symptoms of fibromyalgia.

• Take time out to relax your mind and muscles, for example have a massage.
• Don't drink alcohol, tea or coffee late at night, as these could make sleeping difficult.
• Sleep in a soft collar if your neck is uncomfortable. This may improve your sleep.
• Eat a healthy balanced diet with plenty of fruit and vegetables.

Physical therapies
Try swimming in a heated pool. Heated pool treatment (balneotherapy) can help reduce the pain of fibromyalgia and improve your day-to-day functioning. The benefits can last more than six months. If exercising in the pool is too painful, try bathing alone to begin with. This may also improve your symptoms.
A gentle programme of exercises that increase your heart rate and make you feel slightly out of breath can help improve your symptoms. Gentle muscle stretching exercises two or three times a day and a gentle walk can be good ways to start.
Ask your GP or physiotherapist to help you plan an exercise programme to suit your needs.
Talking therapies
Cognitive behavioural therapy helps some people with fibromyalgia. This is a talking treatment that can help you understand your thoughts (cognitions) and beliefs about your pain and develop new ways of coping with it (behaviours). Talking to other people who have fibromyalgia can reassure you that you are not alone.
Complementary therapies
Some people find that complementary therapies such as acupuncture and massage can help. Ask your GP to refer you to a qualified practitioner.
Medicines
Painkillers you would normally take for a headache can help with the muscle pain associated with fibromyalgia. If these don't help, your GP may prescribe stronger painkillers.
Your GP may also prescribe mild antidepressants to control some of your symptoms such as muscle pain, difficulty in sleeping and anxiety. The starting dose will be lower than that usually used for depression. It's best not to take over-the-counter sleeping tablets because they can cause dependence and eventually lose their effect.
Always ask your doctor or pharmacist for advice before taking any medicines and read the patient information leaflet that comes with your medicine.

http://www.bupa.co.uk/health-information/directory/f/fibromyalgia

Chelsea Therapeutics: Northera (droxidopa)

About Northera™
Northera (droxidopa), the lead investigational agent in Chelsea Therapeutics' broad pipeline, is currently in Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure – a group of diseases that includes Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa is also being studied for the treatment of fibromyalgia, adult attention deficit disorder and chronic fatigue syndrome in three ongoing Phase II trials and completed a Phase II study in intradialytic hypotension (IDH) study with positive results.
http://www.globenewswire.com/newsroom/news.html?d=209503

Jazz Pharmaceuticals: JZP-6 rejected by FDA

It wasn’t exactly the way that California-based Jazz Pharmaceuticals wanted to start the week.
On Monday, October 11, word came through from the Food & Drug Administration that it had rejected the company’s fibromyalgia treatment called JZP-6.
The reason? Turns out it contains sodium oxybate – an active ingredient in GHB, also known as “the date rape drug.”
http://www.investmentu.com/2010/December/when-an-fda-rejection-is-a-good-thing.html

Pregabalin, Gabapentin: Systematic Review of the Comparative Effectiveness of Antiepileptic Drugs for Fibromyalgia

Fibromyalgia is a difficult-to-treat chronic pain syndrome that affects 2% of the US population. Pregabalin is an antiepileptic recently FDA approved for fibromyalgia treatment. Other antiepileptics have been suggested for treatment. This systematic review examines the relative benefits and harms of antiepileptic drugs in the treatment of fibromyalgia. A literature search was conducted and 8 studies matched criteria (7 studies of pregabalin, 1 of gabapentin). Both drugs reduced mean pain scores more than placebo at a modest rate (pregabalin, 38% to 50%; gabapentin, 51%). In a 6-month trial of pregabalin responders, 32% continued to have response at 6 months, with a mean time to loss of response of 34 days. Compared to placebo, the drugs had similarly high rates of adverse events and withdrawals. Without a head-to-head trial it is not possible to conclude if 1 antiepileptic is more effective or harmful than the other, although limited evidence suggests potential differences. Future studies must directly compare the drugs, include a more broadly defined population, examine long term benefits and harms, and include cointerventions. We conclude that pregabalin and gabapentin are modestly effective for the treatment of fibromyalgia but that their long-term safety and efficacy remain unknown.

http://www.jpain.org/article/S1526-5900(10)00744-3/abstract

Will Cymbalta and Ly rica Be Vioxx II?

Martha Rosenberg:  December 17, 2010

The withdrawal of Merck's "super aspirin," the COX-2 specific inhibitor Vioxx from the market may be as distant as the 2004 Bush-Kerry presidential election in the public's memory.
But it's not distant for Whitehouse Station, NJ-based Merck.
Last week the drug giant's profits plummeted 90 percent from dedicating $950 million to resolve a government criminal investigation into Vioxx research and marketing, says the Philadelphia Inquirer.
Merck, accused by the New England Journal of Medicine of concealing "critical data on an array of adverse cardiovascular events" caused by Vioxx, already paid $4.85 billion in 2007 to settle thousands of Vioxx product-liability lawsuits.
Nor is it over for the 27,785 patients who suffered heart attacks and sudden cardiac deaths, according to the Wall Street Journal.
Merck used Olympic gold medalist ice skater Dorothy Hamill to sell Vioxx. She skates five days a week for up to three hours, despite osteoarthritis. She pushed it for everyday minor pain like menstrual cramps.
Merck sold Vioxx as safer and more effective than simpler aspirin and other over-the-counter pain relievers (and some suspect was behind warnings about the safety of Advil and Aleve, publicized soon after Vioxx hit the hot seat). Not that Merck was the only company selling COX-2 specific inhibitors.
Pfizer withdrew Bextra, a similar drug, in 2005 and last year agreed to pay $2.3 billion for fraudulent marketing of Bextra, Lyrica and two other drugs which was the largest criminal fine ever imposed in the U.S. According to the American Heart Association, patients taking Bextra after heart surgery were 2.19 times more likely to suffer a stroke or heart attack.
Only five years earlier, Pfizer, a repeat offender, agreed to pay $430 million for abuses pertaining to seizure drug Neurontin and seven years before that, agreed to pay $49 million to settle charges it defrauded Medicaid by overcharging for cholesterol drug Lipitor.
Pfizer still manufactures the COX-2 specific inhibitor Celebrex, though it is also linked to life-threatening side effects like the case of Timothy Moorley, an outspoken patient in a class action suit against Pfizer in Canada, which is receiving wide publicity.
Though Vioxx and Bextra are gone and Celebrex is under a darkening cloud, the practice of prescribing unsafe drugs for simple pain that can just as easily be treated with older and over-the-counter drugs is alive and well.
FDA linked Lyrica and other seizure drugs to suicide in 2008 and mandated warnings, but Lyrica is widely prescribed off label in civilian and military contexts for pain and migraine -- no doubt from the marketing abuses Pfizer acknowledges in last year's settlement.
When Lyrica was first faced with a black box suicide warning, Pfizer sent FDA a 92-page appeal calling suicide statistics "an exaggeration of risk" that could "over-warn" patients and prescribers and make them "underestimate the risks of declining treatment." Especially revenue risks.
Lyrica, so similar to the deadly drug Neurontin it is called Son of Neurontin, is linked to memory loss, mental confusion, extreme weight gain, hair loss, impaired driving, disorientation, twitching and at least two deaths on the drug rating site askapatient.com
Another dangerous drug now pushed for simple pain is Lilly's Cymbalta.
Many remember Cymbalta as the drug that 19-year-old healthy clinical volunteer Traci Johnson killed herself on during trials on the Lilly campus in 2004 -- soon after FDA investigations into suicide/antidepressant links.
Johnson had no depression history said Rev. Joel Barnaby, a spokesman for the Johnson family, who called Lilly's decision to proceed with Cymbalta's launch as scheduled "offensive" posturing in the Philadelphia Inquirer. Five other suicides occurred during Cymbalta clinical trials, said the FDA and twice the rate of suicide attempts were seen in women who were prescribed the drug for stress and urinary incontinence.
Others remember Cymbalta as the drug Carol Anne Gotbaum, daughter-in-law of New York City Public Advocate Betsy Gotbaum, was taking during her macabre death in police custody at the Phoenix's Sky Harbor airport in 2007. There are 63 published news reports linking Cymbalta to depression, suicide and violence, including the suicide of Ohio 15-year-old Megan Fickert last month.
Last week, FDA approved Cymbalta for chronic musculoskeletal pain, "including discomfort from osteoarthritis and chronic lower back pain."
Cymbalta is the nation's fourth, most advertised prescription drug and Lilly's second bestselling product according to Indianapolis Star's John Russell, who has called it the Swiss Army knife of Lilly drugs. Last year it made a cool $3.1 billion.
Approved for depression, anxiety, fibromyalgia and diabetic nerve pain, the new osteoarthritis and chronic lower back pain indications should double Lilly's take. Already the front page of WebMD, the pharma mouthpiece website whose original partner was Lilly according to the Washington Post, sports three Cymbalta ads -- one for depression and two for pain. Maybe Dorothy Hamill is available.
http://www.huffingtonpost.com/martha-rosenberg/will-cymbalta-and-lyrica-_b_798245.html

Savella: Cypress Bio Bought by Ramius

 

Zacks Equity Research

December 17, 2010

Product Portfolio at Cypress Bio
With this acquisition, Royalty Pharma will gain access to Cypress Bio’s Savella royalty stream. Savella, which is indicated for the treatment of fibromyalgia, is the only marketed product at Cypress Bio.
Savella has been developed under an agreement with Forest Labs and Cypress Bio receives a 15% royalty on product sales. The company was previously co-promoting Savella with Forest Labs. However, the co-promotion agreement was terminated in August 2010.
http://www.zacks.com/stock/news/44844/Cypress+Bio+Bought+by+Ramius

Duloxetine Shows Promise in Aromatase Inhibitor-Associated Musculoskeletal Syndrome

By Jill Stein SAN ANTONIO, Tex -- December 13, 2010 -- The serotonin and norepinephrine reuptake inhibitor duloxetine seems to be effective and well tolerated in women with hormone receptor-positive, early-stage breast cancer treated with an aromatase inhibitor (AI), according to a study presented here at the 33rd annual San Antonio Breast Cancer Symposium (SABCS). Norah L. Henry, MD, University of Michigan, Ann Arbor, Michigan, and colleagues tested the use of duloxetine in postmenopausal women with breast cancer who developed new or worsening grade 1 or higher musculoskeletal pain or sensory neuropathy after receiving adjuvant AI therapy for at least 2 weeks. Treatment for AI-associated musculoskeletal symptoms is often ineffective, Dr. Henry pointed out on December 11. AI-associated musculoskeletal syndrome occurs in roughly half of treated patients. Duloxetine was selected for evaluation because the agent has been effective in the treatment of multiple chronic pain states, including fibromyalgia, osteoarthritis, and low-back pain. The drug may act via alteration of central pain processing. In the trial, women received duloxetine 60 mg daily and had the option of increasing their dose to 60 mg twice daily for a total of 8 weeks. The primary endpoint was a 30% decrease in average pain score over 8 weeks. Results showed that 21 (72.4%) of 29 patients achieved at least a 30% decrease in average pain, and 18 (78.3%) of 23 patients who completed protocol-directed treatment continued duloxetine therapy. Duloxetine therapy reduced pain severity by a mean of 60%, which is comparable to the response rates for other chronic pain conditions, Dr. Henry said. Treatment also improved functional status and depression. Overall, 20.6% of patients stopped therapy prematurely because of side effects. Dr. Henry said that the study findings are limited by the small sample size, "fairly high" discontinuation rate, and lack of a concurrent control group. [Presentation title: Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS). Abstract PD-08-06] http://www.docguide.com/news/content.nsf/news/852576140048867C852577F80072A223

Pramipexole (Mirapex) Lawsuits

Allison Gandey

December 13, 2010 — The sometimes tragic personal toll of impulse control disorders associated with use of the Parkinson's drug pramipexole is now being debated in US and Canadian courtrooms, and a health law expert says these lawsuits have important implications for prescribers.
The drug, marketed under the brand name Mirapex and also used to treat restless legs syndrome, has been shown to trigger compulsive gambling, shopping, eating, and heightened sexuality.
In August, the first pramipexole gambling addiction trial ended in an $8.3 million judgment for the plaintiff against drug-maker Boehringer Ingelheim.
Many lawsuits, including a class action in Canada, are now ongoing, alleging the manufacturer failed to provide patients with appropriate warning of the potential risks. The company declined to comment on how many cases are currently being debated.
"As part of our company's communication policy, Boehringer Ingelheim does not comment on pending litigation," Susan Holz, public relations manager, told Medscape Medical News.
But although current litigation is aimed at the drug manufacturer and not against any physicians, William Mandell, a lawyer specializing in health law with the firm of Pierce and Mandell, PC, in Boston, warned this could change, and prescribers may be held accountable.
"All physicians who regularly prescribe medications for which there could be significant and detrimental side effects should realize that they could also be named as defendants in such adverse reaction suits," Mr. Mandell said.
A prescribing physician could be found liable to a patient if the physician fails to adequately assess the potential risks of a medication's adverse side effects for that individual. This means, in certain situations, physicians should screen patients to determine whether they may be subject to the risks of taking a particular medication.
$8.3 Million Judgment
The first pramipexole case was heard in the US District Court in Minneapolis, Minnesota. Retired police officer Gary Charbonneau reportedly started taking pramipexole for Parkinson's disease in 1997. His lawsuit claimed he had a gambling addiction beginning in 2002 that cost him $260,000.
Charbonneau's lawsuit alleged not only that pramipexole caused his gambling problem but also that Boehringer Ingelheim and Pfizer, which marketed the drug in the United States, knew about its potential to cause compulsive behavior and did not issue any warnings or take steps to investigate the scope of the problem.
Other lawsuits claim the companies received reports linking the drug to compulsive behavior during clinical trials conducted in the 1990s and received additional reports of patients developing gambling addictions but failed to act. The suits charge that it wasn't until 2005 — 8 years after the drug's introduction — that information about compulsive behavior was finally added to the pramipexole label.
The companies argued they were not liable for Charbonneau's addiction because the US Food and Drug Administration (FDA) had not asked for any label changes despite reports that pramipexole was causing compulsive behavior. The companies also claimed that Charbonneau's gambling problems had preceded his use of the drug and continued after he stopped taking it.
The jury hearing the case was not convinced by these arguments. Charbonneau was awarded all of his gambling losses and punitive damages. Many legal experts say there is a good chance similar lawsuits will be successful. Boehringer Ingelheim and Pfizer are planning to appeal the decision. The FDA has declined to comment on the case.
Mr. Mandell was not involved in this lawsuit, but he says the judgment is "a wake-up call" for physicians who prescribe medications that may have significant risks.
Campaign Targeted Physicians
"Although Mirapex was initially hailed as having great promise for patients with Parkinson's disease and those suffering from restless legs syndrome, it turned out that the manufacturers had engaged in a major promotional campaign targeted at physicians and did not fully disclose all risks," he said. "$7.8 million of the jury verdict against the drug manufacturers was for punitive damages related to the finding that they had misrepresented the facts associated with the risks of taking Mirapex as it could cause patients to engage in compulsive behaviors such as gambling."
The companies, Mr. Mandell noted, had gradually changed the labeling information for the drug by listing compulsive behaviors such as pathological gambling under the adverse reactions and precautions sections of the label but stated that those compulsive behaviors "are generally reversible upon dose reduction or treatment discontinuation" and did not list compulsive behaviors in the warnings section of the label.
Asked by Medscape Medical News to comment, Anthony Lang, MD, director of the Movement Disorder Center at Toronto Western Hospital in Ontario, Canada, said the problem is a class effect with dopamine agonists and is not specific to pramipexole. "Many patients have suffered considerably from the presence of impulse control disorders," he noted.
Pramipexole is a nonergoline dopamine agonist. It is also sometimes used off label as a treatment for cluster headache and to counteract problems with sexual dysfunction experienced by some antidepressant users. It is currently being investigated for the treatment of clinical depression and fibromyalgia.
Dr. Lang agreed that physicians have a very important obligation to patients informing them of the potential occurrence of impulse control disorders and monitoring regularly. He pointed out, however, that he has seen patients who at first deny the problems.
"Initiating dopamine agonists has become a very time-consuming process because of the need to inform the patients carefully of the potential problems," he said. "We usually also insist on informing their spouses."
DOMINION Study

Boehringer Ingelheim is currently funding the DOMINION study to explore the link between dopamine agonists and impulse control disorders. Phase 1 of the large cross-sectional trial was published in May in the Archives of Neurology (2010;67:589-595).

As expected, impulse control disorders were more common in those treated with a dopamine agonist, occurring in 17.1% vs 6.9% among those not taking a dopamine agonist (odds ratio, 2.72; 95% confidence interval, 2.08 – 3.54; P < .001). The frequency was reportedly similar between those taking pramipexole vs ropinirole (17.7% vs 15.5%; odds ratio, 1.22; 95% confidence interval, 0.94 – 1.57; P = .14).
The DOMINION study included 3090 patients with Parkinson's disease treated at movement disorder centers in the United States and Canada. Each was assessed using the Massachusetts Gambling Screen for current problem or pathological gambling, the Minnesota Impulsive Disorders Interview for compulsive sexual behavior and buying, and the Diagnostic and Statistical Manual of Mental Disorders research criteria for binge eating.
The findings highlight the need for patients with Parkinson's to be screened for a range of impulse control symptoms as part of routine clinical care, said lead study author Daniel Weintraub, MD, from the University of Pennsylvania, Philadelphia.
Results from phase 2 of the DOMINION study were presented at the American Academy of Neurology 62nd Annual Meeting in April this year.
Here, the researchers found that impulse control disorder patients are much more functionally impaired, are more depressed and anxious, and have more obsessive-compulsive symptoms. They also score higher on scales of novelty seeking and impulsiveness compared with Parkinson's patients who had not developed such disorders.
"What's intriguing about this group of patients is that they're all exposed to the same dopamine agonist, but for some reason, some people develop specific behaviors, and not other behaviors, and the question is why that's the case," said presenter Valerie Voon, MD, from the University of Cambridge, England.
"It may be that some of these associated factors might reflect underlying mechanisms or individual susceptibilities, and we clearly need more prospective studies to identify risk factors for developing these behaviors," she concluded.
New Generic Doses of Pramipexole
Despite these concerns, new generic doses of pramipexole will soon be entering the US market. In October, the FDA approved Mylan Inc's application for new doses, including 0.125, 0.25, 0.5, 1, and 1.5 mg. Mylan already had approval for a 0.75-mg dose.
Mylan said pramipexole had US sales of about $536 million during the 12-month period ending June 30.
"Regardless of whether a medication's label warnings are adequate," Mr. Mandell told Medscape Medical News, "doctors must always exercise their best medical judgment in determining whether a medication is suitable for a patient."
Dr. Lang added, "The ongoing use of this treatment requires regular monitoring and questioning about all of the potential impulse control problems. We do this routinely."

Allison Gandey is a journalist for Medscape. She can be contacted at agandey@webmd.net.
http://www.medscape.com/viewarticle/734153

Aquatic Physical Therapy

Aquatic Physical Therapy requires a doctor referral with a licensed physical therapist doing treatment. The therapist uses the buoyancy, hydrostatic pressure and the warmth to relax the muscles, support submerged joints and reduce or eliminate axial weight bearing, resulting in a reduction of pain.

Warm water is one of the oldest forms of medicine and research indicates warm water works wonders for all kinds of musculoskeletal conditions including fibromyalgia, arthritis and low back pain. It can also help improve your range of motion, balance strength and coordination, and may even reduce your pain medication.

http://www.wausaudailyherald.com/article/20101216/WDH06/12160301/LETTER-Pool-therapy-is-beneficial-to-seniors

Effirma - Flupirtine

With a diverse clinical program looking for new treatments in several different and key central nervous system disorders, Adeona Pharmaceuticals, Inc. (AEN) has great potential and some of those programs look quite likely move into a commercial deal similar to the one the Ann Arbor-based drug development firm locked up earlier this year. That was a $17.5 million deal with Swedish drug maker Meda, but there is likely to be more where that came from.
"The drugs are extremely exciting," says James Kuo, chairman and CFO of Adeona Pharmaceuticals. "They address the needs of large pharma."
Adeona Pharmaceuticals has five drugs in various stages of development and hopes to form another similar corporate partnership or two this year. It’s too bad their depressed stock price doesn’t reflect the progress they are making in the clinic and at their laboratory.
In fact, we’ve noticed that they are starting to become a little more active in their efforts for visibility (CEO is scheduled to start making the rounds and presenting at more conferences, for instance) and maybe that will resonate more with those who follow the company and it should certainly attract new followers and investors to the stock.
Adeona Pharmaceuticals is developing innovative medicines for the treatment of serious Central Nervous System (CNS) diseases. Their primary strategy is to license product candidates that have demonstrated a certain level of clinical efficacy and develop them to a stage that results in a significant commercial collaboration – basically this means they develop their product candidates to attract large pharmaceutical partners with deep pockets.
Those looking for a good trade, need to look elsewhere. We see this as a low-risk, nice reward investment candidate. They have a robust pipeline that includes product candidates in spaces that represent some big markets and unmet needs: a prescription medical food for Alzheimer’s disease, and four drugs for multiple sclerosis, fibromyalgia, age-related macular degeneration and rheumatoid arthritis.
In May 2010, Adeona demonstrated their ability to attract a partner when they entered into a $17.5 million corporate deal with Sweden-based Meda AB for the development of their product candidate flupirtine for the treatment of fibromyalgia. They received an up-front payment of $2.5 million and are entitled to milestone payments of $5 million upon filing of a New Drug Application with the FDA for flupirtine for fibromyalgia and $10 million upon marketing approval. Adeona is also entitled to receive royalties of 7% of net sales of flupirtine approved for the treatment of fibromyalgia.
Below is a listing of the diseases and associated product candidates that they are working on. For those with nearer term potential additional comments have been included:
Treatment of fibromyalgia – Effirma (flupirtine):

• Partnered with Meda AB
• In the press release about the corporate partnership, the company stated that Meda estimates the US market for fibromyalgia to be near $1 billion at the time of potential launch of flupirtine

http://seekingalpha.com/article/241361-adeona-pharmaceuticals-addresses-the-needs-of-large-pharma

CORVALEN

Raj Khankari
Chief Executive Officer
Bioenergy, Inc.
13840 Johnson Street NE
Ham Lake, Minnesota  55304
Dear Mr. Khankari:

On June 14, 30 and July 1, 2010, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility...  During the inspection, the investigator collected your Corvalen M® product label and an order brochure for your Corvalen®, ...and found that your Corvalen®... products are misbranded under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(a)(1)], because the products are labeled and marketed as “medical food” but do not meet the statutory definition of a medical food in the Orphan Drug Act ...Furthermore, these products are promoted for conditions that cause them to be drugs ...in that your products’ labeling is false and misleading.  Your products are labeled and marketed as medical foods for the conditions of fibromyalgia, chronic fatigue syndrome, and cardiovascular disease but do not meet the statutory definition of a medical food set forth in the Orphan Drug Act ...
Specific examples of claims in your order brochure that promote your products as drugs are as follows:

• “Corvalen, with the active ingredient ribose, can help you overcome fatigue caused by fibromyalgia, chronic fatigue, cardiovascular disease….”
• “[C]orvalen helps the body quickly restore energy levels that have been depleted by…disease.”
• “Overcome pain and fatigue associated with:

o Fibromyalgia
o Chronic Fatigue Syndrome
o Cardiovascular disease”

Your order brochure also contains disease claims in the form of personal testimonials, including:

• “The energy building benefit of ribose dramatically improved pain and quality of life in my fibromyalgia and chronic fatigue syndrome patients...
-Dr. Jacob Teitelbaum
certified internist, medical director”  

An example of claims on your Corvalen M® product label are as follows:

• “Clinically proven to improve cardiac function and restore energy diminished by fibromyalgia and chronic fatigue.”...

You should take prompt action to correct the violations described above and prevent their future recurrence.  Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within 15 working days of the receipt of this letter, of the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur.  Include any documentation necessary to show that correction has been achieved.  If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Gerald J. Berg
Director
Minneapolis District
MIM/ccl

   http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm232086.htm 

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MILNACIPRIN: SAVELLA

Milnacipran

(mil na' si pran)

Last revised: April 1, 2009.

U.S. National Library of Medicine
National Institutes of Health

National Center for Biotechnology Information

U.S. National Library of Medicine

National Institutes of Health

Important Warning:

Milnacipran is not used to treat depression, but it belongs to the same class of medications as many antidepressants. Before you take milnaciprin, you should be aware of the risks of taking antidepressants because taking milnaciprin may carry similar risks. During clinical studies, this type of antidepressant ('mood elevator') caused a small number of children, teenagers, and young adults (up to 24 years of age) to become suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should be treated with an antidepressant or antidepressant-like medication. Children younger than 18 years of age should not normally take milnacipran, but in some cases, a doctor may decide that milnacipran is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take milnacipran even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied, abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking milnacipran, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with milnacipran. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.

No matter what your age, before you take an antidepressant, you or your caregiver should talk to your doctor about the risks and benefits of treating your condition with milnaciprin or with other treatments. You should also talk about the risks and benefits of not treating your condition. Although taking milnaciprin or similar medications may increase the risk that you will become suicidal, you should know that there are other things that also increase this risk. If you have depression or another mental illness, there is a greatly increased risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited), mania (frenzied, abnormally excited mood), or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

Why is this medication prescribed?

Milnacipran is used to treat fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). Milnacipran is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It works by increasing the amount of serotonin and norepinephrine, natural substances that help stop the movement of pain signals in the brain.

How should this medicine be used?

Milnacipran comes as a tablet to be taken by mouth. It is usually taken two times a day. Milnacipran may be taken with or without food, but taking it with food will decrease the chance that milnacipran will upset your stomach. Take milnacipran at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take milnacipran exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will start you on a low dose of milnacipran and gradually increase your dose during the first week of treatment.

Milnacipran may help control the symptoms of fibromyalgia, but will not cure it. Do not stop taking milnacipran without talking to your doctor. If you suddenly stop taking milnacipran, you may experience withdrawal symptoms such as mood changes, irritability, agitation, dizziness, numbness or tingling in the hands or feet, anxiety, confusion, headache, tiredness, difficulty falling asleep or staying asleep, ringing in the ears, abnormal excitement, or seizures. Your doctor will probably decrease your dose gradually.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking milnacipran,

• tell your doctor and pharmacist if you are allergic to milnacipran, aspirin, any other medications, or tartrazine (FD&C Yellow No 5).
• tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take milnacipran. If you stop taking milnacipran, you should wait at least 5 days before you start to take an MAO inhibitor.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, or herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); and other antidepressants; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); clonidine (Catapres); clomipramine (Anafranil); digoxin (Lanoxicaps, Digitek, Lanoxin); diuretics ('water pills'); duloxetine (Cymbalta); epinephrine (Epipen, Primatene Mist); lithium (Eskalith, Lithobid); medications for anxiety, mental illness, pain, or seizures; medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); sedatives; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); sleeping pills, tramadol, tranquilizers, and venlafaxine (Effexor). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what nutritional supplements you are taking, especially tryptophan or 5-HTP.
• tell your doctor if you have glaucoma (increased pressure in the eye that may lead to vision loss). Your doctor will probably tell you not to take milnacipran.
• tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had high blood pressure; seizures; an irregular heartbeat; an enlarged or inflamed prostate (a male reproductive gland); difficulty urinating; or heart, kidney, or liver disease. .
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking milnacipran, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking milnacipran.
• you should know that milnacipran may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• talk to your doctor about the safe use of alcoholic beverages while you are taking milnacipran.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Milnacipran may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• constipation
• stomach pain
• weight loss
• dry mouth
• feeling of extreme facial warmth and/or redness
• increased sweating
• headache
• dizziness
• blurred vision
• difficulty falling or staying asleep
• decreased sexual desire or ability
• pain or swelling of the testicles
• difficulty urinating
• rash
• itching

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:

• hallucinations (seeing things or hearing voices that do not exist)
• confusion
• difficulty concentrating
• memory problems
• weakness
• unsteady walking that may cause falling
• seizures
• fainting
• coma (loss of consciousness for a period of time)
• slowed or stopped breathing
• fast or pounding heartbeat
• difficulty breathing
• extreme tiredness
• lack of energy
• loss of appetite
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• flu-like symptoms
• black and tarry stools
• red blood in stools
• bloody vomit
• vomit that looks like coffee grounds
• unusual bleeding or bruising
• nosebleeds
• tiny red spots directly under the skin

Milnacipran may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• extreme sleepiness
• confusion
• dizziness
• coma (loss of consciousness for a period of time)
• slowed or stopped heartbeat and breathing

What other information should I know?

Keep all appointments with your doctor. Your doctor will check your blood pressure and pulse regularly during your treatment with minalcipran.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

In this page

• Why is this medication prescribed?
• How should this medicine be used?
• Other uses for this medicine
• What special precautions should I follow?
• What special dietary instructions should I follow?
• What should I do if I forget a dose?
• What side effects can this medication cause?
• What storage conditions are needed for this medicine?
• In case of emergency/overdose
• What other information should I know?
• Brand names

American Society of Health-System Pharmacists, Disclaimer

AHFS® Consumer Medication Information. © Copyright, 2010. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

The following brand names are from RxNorm, a standardized nomenclature for clinical drugs produced by the National Library of Medicine:

Brand names

• Savella

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000495

Pregabalin

(pre gab' a lin)

Last revised: September 1, 2009.

U.S. National Library of Medicine
National Institutes of Health

National Center for Biotechnology Information

U.S. National Library of Medicine

National Institutes of Health

Why is this medication prescribed?

Pregabalin is used to relieve neuropathic pain (pain from damaged nerves) that can occur in your arms, hands, fingers, legs, feet, or toes if you have diabetes or in the area of your rash if you have had shingles (a painful rash that occurs after infection with herpes zoster). It is also used to treat fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). Pregabalin is used with other medications to treat certain types of seizures in people with epilepsy. Pregabalin is in a class of medications called anticonvulsants. It works by decreasing the number of pain signals that are sent out by damaged nerves in the body.

How should this medicine be used?

Pregabalin comes as a capsule to take by mouth. It is usually taken with or without food two or three times a day. Take pregabalin at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Your doctor will probably start you on a low dose of pregabalin and may gradually increase your dose during the first week of treatment.

Take pregabalin exactly as directed. Pregabalin may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

Pregabalin may help control your symptoms but will not cure your condition. It may take several weeks or longer before you feel the full benefit of pregabalin. Continue to take pregabalin even if you feel well. Do not stop taking pregabalin without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking pregabalin, you may experience withdrawal symptoms, including trouble falling asleep or staying asleep, nausea, diarrhea, headaches, or seizures. Your doctor will probably decrease your dose gradually over at least one week.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with pregabalin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking pregabalin,

• tell your doctor and pharmacist if you are allergic to pregabalin, any other medications, or any of the ingredients in pregabalin capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiotensin converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten, in Capozide), enalapril (Vasotec, in Vaseretic, Lexxel), fosinopril (Monopril), lisinopril (Prinivil, Zestril, in Prinzide, Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon), quinapril (Accupril, in Accuretic, Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); antidepressants; antihistamines; medications for anxiety, including lorazepam (Ativan); medications for mental illness or seizures; certain medications for diabetes such as pioglitazone (Actos, in Duetact) and rosiglitazone (Avandia, in Avandaryl, Avandamet); narcotic pain medications, including oxycodone (OxyContin, in Percocet, others); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications. Also tell your doctor if you have or have ever had swelling of the eyes, face, lips, tongue, or throat; problems with your vision, bleeding problems or a low number of platelets (type of blood cell needed for blood clotting) in your blood, or heart or kidney disease.
• tell your doctor if you are pregnant, or if you or your partner plans to become pregnant. Also tell your doctor if you are breast-feeding. If you or your partner becomes pregnant while you are taking pregabalin, call your doctor. Pregabalin has caused decreased fertility in male animals and birth defects in the offspring of male and female animals who were treated with the medication. There is not enough information to tell if pregabalin causes these problems in humans.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking pregabalin.
• you should know that pregabalin may make you dizzy or drowsy. Do not drive a car operate machinery, or do other dangerous activities until you know how this medication affects you. Ask your doctor when you may do these activities.
• do not drink alcohol while taking pregabalin. Alcohol can add to the drowsiness caused by this medication.
• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking pregabalin for the treatment of epilepsy, mental illness, or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took antiepileptics such as pregabalin to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an antiepileptic medication such as pregabalin, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an antiepileptic medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

If you forget to take a dose and remember a few hours later, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Pregabalin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness
• dizziness
• headache
• dry mouth
• nausea
• vomiting
• constipation
• gas
• bloating
• ''high'' or elevated mood
• speech problems
• difficulty concentrating or paying attention
• confusion
• difficulty remembering or forgetfulness
• anxiety
• lack of coordination
• loss of balance or unsteadiness
• uncontrollable shaking or jerking of a part of the body
• muscle twitching
• weakness
• increased appetite
• weight gain
• swelling of the arms, hands, feet, ankles, or lower legs
• back pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• blurred vision, double vision, or other changes in eyesight
• hives
• rash
• itching
• blisters
• swelling of the eyes face, throat, mouth, lips, gums, tongue, head or neck
• shortness of breath
• wheezing
• muscle pain, tenderness, soreness, or weakness, especially if it comes along with fever
• chest pain

If you have diabetes, you should know that pregabalin has caused skin sores in animals. Pay extra attention to your skin while taking pregabalin, and tell your doctor if you have any sores, redness, or skin problems.

Pregabalin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to pregabalin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

In this page

• Why is this medication prescribed?
• How should this medicine be used?
• Other uses for this medicine
• What special precautions should I follow?
• What special dietary instructions should I follow?
• What should I do if I forget a dose?
• What side effects can this medication cause?
• What storage conditions are needed for this medicine?
• In case of emergency/overdose
• What other information should I know?
• Brand names

American Society of Health-System Pharmacists, Disclaimer

AHFS® Consumer Medication Information. © Copyright, 2010. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

The following brand names are from RxNorm, a standardized nomenclature for clinical drugs produced by the National Library of Medicine:

Brand names

• Lyrica

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000327

Pregabalin was the first drug approved for prescription by the US FDA for the treatment of fibromyalgia

Your constant head pain can be fibromyalgia!

 December 9, 2010,

KUALA LUMPUR: “It is just a pain in your head, just ignore it,” a doctor once told Mary Gaspar, 54, when she consulted him for the continuous pain she had been suffering from.

Mary had been working in a bank before she suffered the unexplained pain since 2005.
“I was told much later, I could have suffered from fibromyalgia or FM in short, since 2005.
“It made me go through a tough state of depression. I was not able to walk and sleep. All these made me cry day and night,” Mary explained further.
That would be the one advice a patient should not take seriously from their doctors but instead, seek a second opinion.
“The pain they feel is real. With the right help, it can be effectively managed,” Dr Mary Suma Cardosa, Consultant Anaesthesiologist at Selayang Hospital as well as the president elect of Malaysian Medical Association (MMA) told attendees to an afternoon session of revelations by South East Asia Fibromyalgia Awareness, Concerns and Trends Survey (Seafacts), recently.
The press conference was organised by Pfizer Inc and it opened the eyes of many who were not aware of such disease.
What causes fibromyalgia or this FM syndrome? Professor Ramani Vijayan, the President of Malaysian Association for the Study of Pain, noted: “There is no scientific consensus as to the cause of this disease.
“It could have developed in individuals with certain vulnerability elements. It may arise from biological factors such as genetics, age, trauma, gender or a tissue injury.
“Depression, anxiety, a person’s belief about pain and coping strategies are just as important.
“Two to five per cent of the people are affected by this debilitating and chronic pain condition.
“It is occurring more often in the young to middle aged females.
“It is characterised by musculoskeletal pain and tenderness in the up, down, left and right regions of the body,” Ramani added.
FM is said to be seven to nine times more common in females.
People with FM are actually suffering from a significant disability and reduced quality of life.
The most vulnerable age group suffering this most common pain condition is between 30 and 65 years of age.
Patients suffering from fibromyalgia will experience symptoms like stiffness, muscle cramps, fatigue and depression.
The severity of pain felt is widespread thus this chronic though not life threatening condition should not be misunderstood.
However, FM has yet to record cases affecting children and those below the age of 20.
According to survey results, one out of five Malaysian patients found their quality of life and ability to participate in hobbies have been strongly impacted by this disease.
And four out of 10 FM sufferers or 38 per cent, agreed that FM had caused their quality of work to deteriorate.
“Three quarters of GPs and almost all specialists surveyed agreed that fibromyalgia is not well understood among many physicians.
“Education, training and support from physicians are the keys to enabling them to help manage FM patients,” said Dr Mary Cardosa.
Most FM patients have to wait between 3.3 to 15.4 months, with an average of two physician visits before receiving an accurate diagnosis.
FM sufferers worldwide, also have to endure tenderness at almost eleven different points — top or bottom, left and right.
Treatment and management of FM involves a multi-faceted approach.
It includes exercise, behavioural management and lastly the approved medication.
Patients suffering from FM are dependent on complete medication reliance until they feel better or learn to manage their fibromyalgia, coping with the management procedures.
Sadly, there are no available laboratory tests to diagnose the symptoms of FM.
Forty million people suffer from this chronic pain disease worldwide.
“A total of 506 people took the survey in South East Asia. A total of 941 physicians were also asked about their understanding on fibromyalgia.
“The outcome proved that the disease is poorly understood by both quarters.
“The survey also revealed that this negatively impactful disease can cause people experiencing the chronic condition to suffer serious financial consequences, from the condition, including the inability to work,” said Professor Ramani, also shared when the Seafact Survey results were revealed.
Pregabalin was the first drug approved for prescription by the US FDA for the treatment of fibromyalgia.
The drug was effective, it reduced symptoms of pain, disturbed sleeps and fatigue.
Patients and physicians from Indonesia, Malaysia, Philippines, Singapore and Thailand took part in this Seafact survey, held from June right through August 2009.
Currently there are no short cuts to relieving an FM sufferer of pain.
Drugs alone will not take the debilitating pains away but they will ease one’s suffering if the medications; as prescribed by a physician or upon referrals to a specialist, is taken with a consistent exercise session, done after sufficient knowledge had been acquired.
“I had to learn how to manage my pain. I exposed myself to the standing and sitting tolerance to extend pain endurance.
“I cannot and must not lift anything as it would exert more pressure on the pain I felt.
“I began to think positively and that had helped me to cope better,” said Mary Gaspar, accompanied throughout the afternoon session by her supportive husband.
Seeking the doctor’s advice even if the pain felt was at one isolated area only, is a must do.
Mary insists that exercising is the main key towards managing one’s FM pain.
“Having an FM support group is another option to expedite the know-your-disease factor.
“Informing the patients and their family members at home on the hypersensitivity to pain conditions suffered, is very essential.
“It would help patients feel less awkward talking about the pain they feel and possible home remedies to try on,” Dr Mary also recommended.
Fibromyalgia is not an imaginary pain.
It is a disease that has yet to set its clinical practice guidelines for physicians to follow through.
If you feel pain and tenderness upon self pain examination, reach out for help and visit a physician for the next positive step forward.
http://www.theborneopost.com/?p=79486