More Hope for People with Fibromyalgia Pain
Chronic fatigue syndrome (CFS) and fibromyalgia1 (FM) share many symptoms. Studies of both patient groups estimate that in referral clinics, up to 70% of FM patients will meet the criteria for CFS, and 35-70% of CFS patients meet the definition for FM. Although some research studies have found differences between carefully selected FM and CFS patient groups, in the real world there is great similarity in the experience of having CFS and having FM.
Pain, disrupted sleep and difficulty thinking and concentrating are some of the symptoms that plague both CFS and FM sufferers. For both conditions, symptom management is still the state of the medical art; neither one has a primary therapy or cure.
Three drugs, Lyrica, Cymbalta and Savella, have been approved for the management of FM, while CFS still awaits its first FDA-approved treatment. CFS patients give mixed reviews of these drugs in online forums and at meetings and conferences, but for those seeking better control over symptoms, more awareness of Lyrica, Cymbalta and Savella might be helpful before your next appointment with a health care professional.
Keep in mind that most drugs have side effects and potentially dangerous interactions with other prescription, over-the-counter and natural therapies. Most CFS patients find that they are unusually sensitive to medications and that they cannot tolerate even the standard minimum dosages. As with any new medicine, start low and increase slowly. Monitor benefits and side effects and discuss any changes (good or bad) with your prescribing professional or pharmacist. Antidepressant medications Cymbalta and Savella are required to carry safety information about the increased risk of suicidality reported in studies of these types of medicines.
Name: Lyrica™ (pregabalin)
FDA Approval: June 2007
Type of Drug: antiepileptic
Recommended Dosage: 150-450 mg daily
Average Retail Cost: $1.50-$2.63 per 25 mg
Other FDA-Approved Indications: Nerve pain associated with diabetes, nerve pain associated with shingles, add-on treatment of partial seizures
Proposed Mechanism of Action: “Although the exact mechanism of action is unknown, results from animal studies suggest that Lyrica reduces the number of electrical signals that the brain cells send to each other. This could reduce the amount of pain you feel from fibromyalgia.” (Pfizer)
Name: Cymbalta™ (duloxetine hydrochloride)
Manufacturer: Eli Lilly & Co.
FDA Approval: June 2008
Type of Drug: serotonin-norepinephrine reuptake inhibitor (SNRI)
Recommended Dosage: 60 mg
Average Retail Cost: $2.21-$4.38 per 60 mg
Other FDA-Approved Indications: Depression, generalized anxiety disorder (GAD), diabetic nerve pain (DNP)
Proposed Mechanism of Action: “While the mechanism of action for Cymbalta is not fully known, its effects on depression, GAD, DNP, and fibromyalgia may be due to increasing the activity of two naturally occurring substances in the central nervous system, serotonin and norepinephrine.” (Lilly)
Name: Savella™ (milnacipran HCl)
Manufacturer: Forest Laboratories and Cypress Bioscience, Inc.
FDA Approval: January 2009
Type of Drug: selective serotonin and norepinephrine dual reuptake inhibitor (SNRI)
Dosages Tested in Clinical Trials: 100 mg/day and 200 mg/day
Average Retail Cost: (not yet available; due to be in pharmacies in March 2009)
Other FDA-Approved Indications: No other approved indications
Proposed Mechanism of Action: “Although the exact mechanism by which Savella improves the symptoms of fibromyalgia is unknown, some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia. Savella blocks the reuptake of both norepinephrine and serotonin, with greater selectivity for the inhibition of norepinephrine reuptake in vitro. This may be the mechanism by which Savella acts to improve the symptoms of fibromyalgia.” (Forest Laboratories, Inc.)
Big-budget national advertising campaigns to expand awareness of fibroymalgia and demand for Lyrica and Cymbalta have drawn criticism from journalists and people inside the medical community. Some patients feel mislead and deeply disappointed when the drugs don’t work for them. Pharmaceutical company spokespersons and FM patient advocates respond that the backlash is likely a consequence of increased awareness of a condition that has been misunderstood for too long, and for which more research is needed.
Whether you or a loved have been diagnosed with FM or you’d like to explore “off-label” use of one of these drugs, take time to become more informed. The drug sites listed below include more information about which symptoms each one is most effective in treating, common and rare side effects, and helpful tips for talking to your doctor about these medications.
For More Information:
Drug Prices: www.PharmacyChecker.com
Help Paying for Prescription Medications: The Partnership for Prescription Assistance is a service sponsored by the pharmaceutical industry. It offers a single point of access to more than 475 patient assistance programs. www.PPARx.org.
FDA Consumer Fact Sheet:
Living with Fibromyalgia; drugs approved to manage pain
1Fibromyalgia, also known as fibromyalgia syndrome, fibromyositis and fibrositis, is characterized by chronic widespread pain, multiple tender points, abnormal pain processing, sleep disturbances, fatigue and often psychological distress. For those with severe symptoms, fibromyalgia can be extremely debilitating and interfere with basic daily activities. To receive a diagnosis of FM, the patient must meet the following diagnostic criteria:
Widespread pain in all four quadrants of the body for a minimum duration of three months
Tenderness or pain in at least 11 of the 18 specified tender points when pressure is applied
Other symptoms include moderate to severe fatigue, sleep disorders, problems with cognitive functioning, irritable bowel syndrome (IBS), headaches and migraines, anxiety and depression and environmental sensitivities. The presence of other diseases, such as rheumatoid arthritis or lupus, does not rule out an FM diagnosis. For more information about FM: www.fmaware.org, www.painfoundation.org and www.niams.nih.gov.
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