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European CHMP Adopts Negative Opinion on Cymbalta for the Treatment of Fibromyalgia
Date:10/24/2008

nditions (both treatable and life-threatening) have similar symptoms.(10) To diagnose fibromyalgia, physicians apply pressure to a series of "tender points" throughout the body(9) and ask the patient if it feels painful. The American College of Rheumatology (ACR) classification criteria for fibromyalgia are the most commonly used in clinical and therapeutic research.(11) The accepted diagnostic criteria require that spontaneous pain be present for over three month's duration along the spine and in all four quadrants of the body.(10)

About Duloxetine

While duloxetine's mechanism of action in humans is not fully known, it is believed to affect both serotonin and norepinephrine/noradrenaline mediated nerve signaling in the brain and the spinal cord. Based on pre-clinical studies, duloxetine is a reuptake inhibitor of serotonin and norepinephrine/noradrenaline. Scientists believe its effect on pain perception is due to increasing the activity of serotonin and norepinephrine in the central nervous system.

Duloxetine is approved for the treatment of major depressive disorder and diabetic peripheral neuropathic pain in many countries, and is approved in some countries for the treatment of stress urinary incontinence and generalised anxiety disorder. Duloxetine is approved only for adults 18 and over. There is a possibility of an increased risk of suicidal thoughts or behaviour in children and young adults treated with antidepressants. Patients should call their doctor right away if they experience worsening depression symptoms, unusual changes in behaviour or thoughts of suicide, especially at the beginning of treatment or after a change in dose.

Patients taking duloxetine may experience dizziness or fainting upon standing. The most common side effects of duloxetine include:

-- For depression: Nausea, dry mouth, headache, insomnia, diarrhoea

-- For diabetic peripheral neuropathic pain: Nausea, somnolence

(sleepiness)
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SOURCE Eli Lilly and Company
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