New drugs: milnacipran hydrochloride, fesoterodine fumarate, and silodosin.

Agent for fi bromyalgia Fibromyalgia is one of the most common types of chronic widespread muscle pain, affecting an estimated 3 to 6 million Americans. Most patients with this disorder are women (>80%) who typically develop the condition in early-to-middle adulthood. Patients may experience different types of symptoms, the most common of which include muscle soreness, tenderness, fl u-like aching, dull pain in the muscles, morning stiffness, fatigue, and problems sleeping. The American College of Rheumatology has identifi ed criteria for a diagnosis of fi bromyalgia that include widespread pain lasting for at least 3 months, plus pain present at 11 or more of the 18 parts of the body called “tender points.” Medications such as analgesics, muscle relaxants, antidepressants, antiepileptic drugs, and agents for insomnia have been used in the management of fi bromyalgia, but often without success. In 2007, pregabalin (Lyrica) was the fi rst drug to be approved by the Food and Drug Administration (FDA) for managing fi bromyalgia. It had already been on the market with indications that included managing neuropathic pain associated with diabetic peripheral neuropathy, managing postherpetic neuralgia, and adjunctive therapy for adult patients with partialonset seizures. Duloxetine (Cymbalta) was the second agent to be approved (in 2008) for managing fi bromyalgia, having already been marketed for the management of neuropathic pain associated with diabetic peripheral neuropathy, the acute and maintenance treatment of major depressive disorder, and the acute treatment of generalized anxiety disorder. Milnacipran hydrochloride (Savella— Forest; Cypress) is the third drug to be approved for managing fi bromyalgia, which is its only indication in the United States, although it is marketed in certain other countries for treating depression. Like for each of these agents includes a boxed warning regarding the increased risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (aged 18–24 years). All patients treated with one of these agents should be closely observed for clinical worsening, suicidality, and unusual changes in behavior, particularly during the fi rst several months of therapy and when the dosage is changed. The use of milnacipran is contraindicated in patients treated with a monoamine oxidase inhibitor (MAOI) or within 14 days after discontinuing an MAOI. Treatment with an MAOI should not be initiated for at least 5 days following discontinuation of therapy with milnacipran. The development of a life-threatening serotonin syndrome (e.g., mental status changes, autonomic instability, neuromuscular aberrations) may occur with milnacipran, other SNRIs, and SSRIs, particularly if another serotonergic drug (e.g., triptans, tramadol [e.g., Ultram]) is used concurrently. The concomitant use of these agents must be closely monitored, especially when treatment is being initiated and when dosages are increased. The concurrent use of milnacipran with tryptophan, a serotonin precursor, is not recommended. As with other central nervous system–active drugs, patients should be advised to avoid consuming alcoholic beverages while being treated with milnacipran. Some patients treated with milnacipran, other SNRIs, or a SSRI have experienced seizures, hyponatremia, and abnormal bleeding, and treatment should be closely monitored in patients who are at greater risk of these complications. The risk of bleeding events is increased by concurrent use of warfarin (e.g., Coumadin) and other anticoagulants, aspirin, and nonsteroidal anti-infl ammatory drugs. The SNRIs, including milnacipran, have been associated with increases in