Treatment During Pregnancy

Fibromyalgia is a disorder that causes intense generalized fatigue, muscle pain, joint stiffness, anxiety, irritability, heightened sensitivity to external stimuli and sleep disturbances. There is no known cause for the condition. It cannot be cured and can only be moderately treated with medications. The medications don’t prevent the condition but can treat many of the symptoms. Sometimes fibromyalgia is overlooked during pregnancy and is often misdiagnosed as regular symptoms of pregnancy if the woman gets it for the first time while she is pregnant.

This is partly due to the highly generalized criteria for diagnosing the condition. Researchers are currently working on more accurate ways to diagnose fibromyalgia so that it can more easily be diagnosed in pregnant women as well as other individuals.

Fibromyalgia During Pregnancy

Women who have diagnosed or undiagnosed fibromyalgia before pregnancy tend to have worse symptoms during their pregnancy, according to the few studies that have been done on pregnant women and fibromyalgia. Symptoms tend to worsen in the third trimester. Researchers suspect the reason for this may be due to the higher amounts of the hormone relaxin produced during pregnancy as well as the physical and emotional stress placed on the body during pregnancy.

Treatments

There are very few to no medical pain relievers accepted as entirely safe for use during pregnancy. This means that pregnant women have limited options for treating the symptoms of the condition and must find other ways to manage the pain. If a woman is pregnant, most doctors will recommend against the pain relievers and antidepressants commonly used for treatment.

Is It Dangerous for the Baby?

Medications used to treat fibromyalgia can be dangerous for the baby but the condition itself isn’t. It doesn’t cut blood flow to the developing fetus and babies born of mothers with fibromyalgia don’t have more health problems than the general public and they don’t experience growth restrictions. Since there is no threat to the baby, it isn’t necessary to see a high-risk obstetrician unless your regular obstetrician suggests it.

Non-Medical Ways to Manage

Pregnant women with fibromyalgia have the challenging task of trying to manage the condition with no medication. Limited amounts of fibromyalgia medications will be prescribed if the symptoms are so severe that there is no other option, but there’s always concern that the drugs could damage the developing child.

Doctors recommend plenty of rest during pregnancy especially if a woman has fibromyalgia. The suggested amount of rest is at least two to three times during the day for about 20 to 30 minutes. The use of moist heat is encouraged to help manage the pain and this includes warm showers or baths.

Exercise like yoga is also encouraged. Exercise increases serotonin levels which can help with fibromyalgia symptoms like irritability and depression. Experts also suggest that women have a strong support system to help them when the symptoms of fibromyalgia become worse. Strong emotional support goes a long way towards helping women manage with the condition when there is no other option.

Waxing Lyrical Over Lyrica

Pfizer’s Lyrica (pregabalin) was the first medication ever approved by the USFDA for fibromyalgia. The anticonvulsant drug was developed to treat both partial seizures as are seen in temporal lobe epilepsy and neuropathic pain. The drug is also useful for spinal cord injuries. In Europe, doctors prescribe pregabalin as a medication for treating generalized anxiety disorder. The drug received first approval in Europe in the year 2004 and in the States in 2005.

In the United States, Lyrica has received approval as a medication that may be prescribed to treat epilepsy, diabetic nerve pain (neuropathy), and painful shingles (post-herpetic neuralgia). The FDA decided to approve the drug as a treatment for fibromyalgia as well, in 2007. Fibromyalgia manifests as widespread joint and muscle pain. The merest touch can cause excruciating pain in fibromyalgia sufferers.

In 2009, a subsidiary of Pfizer pleaded guilty to the charge of mischaracterizing Lyrica and three other drugs, with intent to mislead consumers. By illegal promotion of the drugs, false claims were submitted to government healthcare programs for use of the drugs in ways not medically sanctioned. Pfizer made a settlement of $2.3 billion and signed a corporate integrity agreement.

Side Effects?

No drug is free of side effects, and Lyrica is no exception. About 10% of patients treated with the drug experience dizziness or drowsiness. A somewhat smaller number of patients report problems with vision, coordination, speech, tremors, memory, lethargy, weight gain, constipation, euphoria, erectile dysfunction, swelling of the ankles, legs, and feet, and loss of libido. Fewer than 1% of those on pregabalin experience kidney stones, urinary problems, joint and muscle pain, cramped muscles, rashes, reddened skin, sweating, excessive salivation, an increase in heart rate, change in sensitivity response to touch, twitching muscles, hallucinations, agitation, confusion, or depression.

A smaller number of patients on the medication, fewer than 0.1%, find themselves with low neutrophil counts—these are a type of white blood cell, changes in blood pressure, pancreatic inflammation, heart block, cessation of urine production, skeletal muscle tissue breakdown, and difficulty swallowing.

There is a very low likelihood of developing a dependence of pregabalin. Those who experience withdrawal symptoms, often do so after having been treated with the drug for a lengthy period of time. Symptoms of withdrawal include anxiety, insomnia, and restlessness. While it is rare for a patient to experience dependence on Lyrica, it’s best to reduce the dosage of pregabalin on a gradual basis. 

Drug Interactions

Pfizer says there are some dangerous drug interactions that can occur with Lyrica, in particular with these drugs and substances:

*Drugs that serve to depress the central nervous system

*Alcohol

*Barbiturates

*Benzodiazepines

*Opioids

Early Treatment Crucial

Research has uncovered the fact that the brains of fibromyalgia sufferers show reduced activity in those areas responsible for inhibiting pain. Furthermore, it has been proven that drugs affecting the central nervous system are effective measures for treating fibromyalgia, in particular when they are administered early on. These new facts have been revealed in a thesis written by Karin B. Jensen, a postgraduate student at the Swedish medical university, the Karolinska Instituet.

Jensen, hailing from the Instituet’s Department of Clinical Neuroscience said, “It’s a common misconception that fibromyalgia is a manifestation of mental problems. But in the studies that comprise my thesis, we’ve made careful measurements and have found no correlation at all between pain sensitivity in fibromyalgia patients and the degree of anxiety or depression they show.”

Less Activity

In one study performed by Jensen’s team, two groups of participants—one with fibromyalgia, the other healthy—had their thumbs squeezed until they felt mild pain. By employing functional magnetic resonance imaging, fMRI, the researchers were able to demonstrate that both groups displayed similar levels of activity in those parts of the brain that experience emotions as well as those areas which contain the thumb’s assensory information. But the fibromyalgia group had less activity in the part of the brain that attempts to inhibit pain.

Further, the team found that drugs acting on the central nervous system, for instance SNRI antidepressants are an effective treatment for fibromyalgia. However, it is not the antidepressant nature of the drugs that work against fibromyalgia, but rather other properties inherent in these medications.

Early Detection

Jensen elaborates that those patients who had experienced pain for the shortest period of time were the most responsive to the medications tested. This suggests that patients receiving the medication early on in the course of their disease had shown the best response. The researcher believes that this is further proof of how imperative it is that fibromyalgia be detected and treated as soon as possible.

Jensen’s thesis also treats the idea of a relationship between pain regulation and genetics. Studies performed on healthy subjects prove a connection between a certain genetic variation and response to drugs such as morphine in relation to repetitive pain stimulus. While still under study, it appears this gene only affects the body’s ability to regulate pain at times of psychological distress. The research team believes this knowledge may one day prove crucial in the development of more personalized treatment which might lead to improved, more efficacious pain relief.

JZP-6 No Threat To Existing Treatments

Jazz Pharmaceuticals has already filed an application with the FDA for its fibromyalgia treatment JZP-6 (sodium oxybate oral solution). That means there’s a good chance that this new treatment will be the fourth medication approved to treat fibromyalgia syndrome (FMS). Be that as it may, JZP-6 is unlikely to threaten sales of the other three fibromyalgia treatments on the market.

Liquid Ecstasy

That’s because sodium oxybate is a liquid form of ecstasy, which is a well-known recreational drug with a serious potential for abuse. Also, the drug is not going to be in wide supply and will come with a hefty price tag affixed. On the other hand, in two separate Phase III trials, sodium oxybate gave significant pain relief, reduced fatigue, and improved the daily functioning, sleep quality, and global impression of change in fibromyalgia patients.

Fibromyalgia is a debilitating condition causing widespread muscle pain and fatigue which affects mostly women. Around 6 million US residents suffer from FMS. But the condition is little understood.

Thus far, three drugs have been approved by the FDA for the treatment of FMS: Lyrica (Pfizer’s pregabalin), Cymbalta (Eli Lilly’s and Boehringer Ingelheim’s duloxetine), and Savella (Pierre Fabre and Forest’s milnacipran). These drugs only received approval during the past two and a half years. Because of the entrance of these treatments on the market, a greater awareness of fibromyalgia has grown and developed.

New Kid

The new kid on the fibromyalgia medication block, sodium oxybate, is gamma-hydroxybutyrate in sodium salt form. Gamma-hydroxybutyrate is known as an endogenous neurotransmitter as well as a metabolite of GABA.

Already marketed as Xyrem for treating cataplexy, a sudden temporary loss of muscle tone and a symptom associated with narcolepsy, the FDA classifies this drug as a controlled substance (Schedule III drug). By law, Xyrem is labeled with a black box warning stating that the drug depresses the central nervous system, carries the potential for abuse, and cannot be used in tandem with alcohol or other central nervous system depressants.

Xyrem has earned a decent reputation with sleep experts and this should boost the success of JZP-6 as a fibromyalgia treatment. But marketing experts predict that due to the black box warning, a certain stigma will be attached to the use of JZP-6, limiting its potential value as a treatment for fibromyalgia.  Restricted distribution plus a high price tag will tend to limit the potential of sodium oxybate as a widely-used treatment for fibromyalgia.

Pharmaceutical companies are looking at a liquid form of ecstasy to help treat fibromyalgia. While that may not happen within the next several months, ecstasy remains to be a popular drug of choice among many, which can cause ecstasy overdose with very unpleasant symptoms.

Direct Treatment Effect With Cymbalta

Pooled Data

According to data coming out of four separate clinical trials, patients who suffer from both depression and fibromyalgia experience significant improvement for the two conditions when they are treated with duloxetine (Cymbalta). The pooled data from these trials were presented in San Antonio, Texas, at a meeting of the American Academy of Pain. It seems that Cymbalta relieves pain in the same measure no matter the severity of the level of the patient’s depression, while mood improves no matter the severity level of the patient’s pain.

Mood Improvement

An analysis of the data from these trials showed that the medication yielded both direct and indirect benefits in pain and mood improvement. The data suggests that the direct benefit of the drug is between 60%-70% while the indirect benefit makes up the remaining 30%-40% of the apparent improvement in pain and mood. Lauren B. Marangell MD, of the Indianapolis-based Eli Lilly &Co. and her colleagues, made a presentation in poster form at the meeting which stated, “Improvement in pain and improvement in major depressive disorder are positively correlated. Improvement in pain reflected greater direct treatment effect with an indirect effect of improved mood, indicating that the improvement seen with duloxetine in fibromyalgia is not solely a mood effect.”

The presentation emphasized that mood improvement was discovered to reflect the greater, more direct effect of the treatment, while pain improvement was found to be an indirect benefit of the drug therapy. The researchers stated in their presentation that these findings show that duloxetine can have an independent benefit in treating the pain of fibromyalgia, even where depression is not co-morbid.

Shout Out

Up to a third of all fibromyalgia patients suffer from major depression, as well, while 70% of all fibromyalgia patients have a history for major depression. Trying to figure out how these two conditions fit in with each other gets muddled because pain tends to shout its presence, which serves to obscure the depression. This can lead to undiagnosed, co-morbid depression, which in turn may mean that the depression part of the equation goes untreated.

To confuse matters further, major depression can worsen in response to the way that pain gets in the way of everyday activities. That means that worsening depression leads to an increase in reports of pain with the pain increasing in intensity and in duration in those patients afflicted with fibromyalgia.

Chili Peppers May Save The Day

Scientists have known for awhile that a natural chemical named capsaicin is responsible for the heat of chili peppers. Capsaicin has the ability to bind to receptors contained within the cells that line the inside of your mouth. The result is that familiar burning sensation of which some people can’t get enough.

Hot Stuff 

Researchers at San Antonio’s University of Texas (UT) are grateful to the chili pepper for helping them find a way to stem pain at its source. This finding promises hope to people all over the world who suffer from chronic pain. A report of these discoveries has been published in the April 26, 2010 Journal of Clinical Investigation.

Stopped Cold

The UT researchers found that something resembling capsaicin exists at points of pain within the body. They then saw that if they blocked the production of this substance, the pain too, was stopped cold. These capsaicin-resembling molecules trigger the pain receptor known as transient potential vanilloid 1 (TRPV1). TRPV1 pain neurons are activated in response to trauma. Eating a chili pepper will also activate these TRPV1 pain receptors.

When scientists eliminated the gene for these pain receptors in mice, the mice no longer showed sensitivity to the capsaicin-resembling substance. The researchers also found that as pain is experienced, the body responds by producing something much like capsaicin. This substance is a mishmash of several fatty acids that combine to create oxidized linoleic acid metabolites (OLAMs).

Dr. Kenneth Hargreaves, lead researcher on the project said, “This is a major breakthrough in understanding the mechanisms of pain and how to most effectively treat it.” Hargreaves is a professor who chairs the Department of Endontics Dental School at the UT Health Science Center. “These data demonstrates, for the first time that OLAMs constitute a new family of naturally occurring capsaicin-like agents, and may explain the role of these substances in many pain conditions.”

New Treatments

Hargreaves says that this hypothesis suggests the idea that blocking activity or the production of such substances may be the way toward finding new ways of treating a variety of pain disorders and inflammatory diseases.

The Texas team has already managed to devise two separate drugs that can either block or inactivate the OLAMs. They now hope to find a suitable way of administering these drugs as a topical or oral drug, or as an injection. Such a treatment method may prove invaluable for those who suffer from the chronic pain of fibromyalgia or cancer.

Experts believe that 50 million Americans are forced to live with chronic pain. A study performed in 2000 showed that 36 million Americans had lost work time because of chronic pain. This new finding should lead to non-addictive treatments that can target pain at its source as opposed to conventional pain meds which must travel all the way to the nervous system and the brain.