FDA Approves Cymbalta® for Chronic Back Pain & Arthritis
November 11, 2010
The U.S. Food and Drug Administration (FDA) has approved duloxetine hydrochloride (Cymbalta®) for the treatment of chronic musculoskeletal pain, including pain caused by osteoarthritis and lower back pain.
The FDA first approved Cymbalta in 2004 to treat depression. Since that time, it has received FDA approval for the treatment of diabetic peripheral neuropathy (i.e., diabetes nerve damage), generalized anxiety disorder and fibromyalgia, according to an FDA news release.
The safety and effectiveness of Cymbalta for treating osteoarthritis and lower back pain was demonstrated in four randomized, double-blind, placebo-controlled clinical trails involving over 600 people, as well as in post-marketing data from the drug's previous approvals.
While Cymbalta is generally well tolerated, side effects can occur; the most common are nausea, dry mouth, insomnia, drowsiness, fatigue, constipation and dizziness. More serious reactions can include pneumonia, liver damage, allergic reactions, and suicidal thoughts and behaviors.
Because of the risk of suicidal thoughts, particularly among teenagers and young adults up to 24 years of age, Cymbalta carries a "black box" warning label describing these risks. People who are concerned about these risks should speak to their doctor about alternative treatments for pain or depression.
Source:FDA news release