FDA Clears Cymbalta to Treat Chronic Lower Back Pain, Osteoarthritis

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The antidepressant Cymbalta has gotten the go-ahead to be prescribed for persistent back pain and osteoarthritis, the Food and Drug Administration said.

The FDA approved the drug on Thursday for chronic musculoskeletal pain, including pain in the lower back and that caused by osteoarthritis.

"Up to three quarters of the population experience chronic pain at some time in their lives," Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said in a statement. "This approval means that many of those people now have another treatment option."

Cymbalta first emerged in 2004 as a medication for major depressive disorder. Since then, about 30 million people in the United States have used it.

After its release as an antidepressant, Cymbalta was also approved as a treatment for fibromyalgia, generalized anxiety disorder and diabetic peripheral neuropathy.

More than 600 patients participated in randomized clinical trials on the effectiveness of Cymbalta, or duloxetine hydrochloride, in alleviating lower back pain and symptoms of osteoarthritis. By the end of the study, the subjects taking the drug reported a significant reduction in back pain compared with those who were given placebos, the FDA said.

The most common side effects of Cymbalta are nausea, dry mouth, insomnia, drowsiness, dizziness, fatigue and constipation. Other, more serious, side effects have been seen in less than 1 percent of patients, including liver damage, hives, rashes and other allergic reactions, depression, pneumonia, suicide and suicidal thoughts, according to the agency.

Currently there are few drugs on the market that treat chronic musculoskeletal pain, all of which carry the risk of severe side effects. For some patients, none of the existing treatments are effective in treating their pain.

The FDA said Cymbalta, made by drug giant Eli Lilly and Co., should be taken in a 60 milligram capsule once a day and needs to be swallowed whole rather than crushed or mixed with food or liquids.

Any unpleasant reactions to the drug can be reported to the FDA's MedWatch hotline at 1-800-FDA-1088, or online at www.fda.gov/medwatch/how.htm.

Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

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