"Up to three-quarters of the population experience chronic pain at some time in their lives," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement."This approval means that many of those people now have another treatment option."
A clinical trail of more than 29,000 patients including people with osteoarthritis and chronic low back pain took one 60-milligram capsule of Cymbalta once a day. The people taking Cymbalta (duloxetine hydrochloride) had significantly reduced chronic pain, compared with a placebo.
The most common side effects among Cymbalta users were nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. There were serious side effects as well, including liver damage, hives, rashes, swelling in the face, pneumonia, depressed mood, and suicidal thoughts and behavior. These more serious side effects have occurred in less than 1% of patients taking Cymbalta.
Cymbalta (duloxetine hydrochloride) is a brand name drug manufactured by Eli Lilly and Co., a major pharmaceutical company based in Indianapolis. Since its approval in 2004, an estimated 30 million people have used Cymbalta.