Duloxetine Is Safe in Adolescents with Fibromyalgia, Study Reports

Duloxetine Is Safe in Adolescents with Fibromyalgia, Study Reports
Duloxetine, commonly used to treat fibromyalgia in adults, did not decrease average pain scores for adolescents living with with the disease when compared to a placebo, a study showed. However, more patients treated with the drug reported some reduction in pain scores, and no new safety concerns were identified. The study, "Efficacy and safety of duloxetine versus placebo in adolescents with juvenile fibromyalgia: results from a randomized controlled trial," was published in the journal Pediatric Rheumatology.  Duloxetine (brand names include Cymbalta and Irenka) is a serotonin and norepinephrine re-uptake inhibitor, meaning that it prolongs the activity of neurotransmitters (i.e. serotonin and norepinephrine), chemicals brain cells use to send signals. The medication is approved by the U.S. Food and Drug Administration (FDA) for several uses, including treating depression, generalized anxiety disorder, and a variety of pain conditions. Cymbalta is approved for the treatment of fibromyalgia in adults, but not in younger fibromyalgia patients. There are currently no medications approved to treat adolescent fibromyalgia. This study reports the results of a Phase 3b clinical trial (NCT01237587) that tested whether duloxetine could reduce pain in adolescents with fibromyalgia in a safe manner. In the trial, fibromyalgia patients from the United States, Puerto Rico, Argentina, and India who were between 13 and 17 years old were recruited and randomly assigned to be given either a placebo or duloxetine for 13 weeks. Duloxetine was given at a dose of 30 mg, taken as a pill, for the first week; the dose was then doubled (60 mg) for the rest of the study, although clinicians were permitted to adjust dosages based on patients' responses. In total, 184 patie
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