Navigation Links
FDA Clears Cymbalta to Treat Chronic Musculoskeletal Pain

SILVER SPRING, Md., Nov. 4, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Cymbalta (duloxetine hydrochloride) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. Cymbalta was first used to treat major depressive disorder in 2004.  



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

Since its initial approval, about 30 million patients in the United States have used Cymbalta. It was approved for the treatment of diabetic peripheral neuropathy in 2004; generalized anxiety disorder and maintenance treatment of major depression in 2007; and fibromyalgia in 2008.

More than 29,000 patients have used Cymbalta in clinical trials, and more than 600 patients were studied in the clinical trials involving osteoarthritis and chronic low back pain. The safety evaluation for Cymbalta included review of data from the clinical trials as well as post-marketing data from the previously approved patient populations.

The FDA assessed the efficacy of Cymbalta in chronic low back pain and osteoarthritis in four double-blind, placebo-controlled, randomized clinical trials. At the end of the study period, patients taking Cymbalta had a significantly greater pain reduction compared with placebo.

The most common side effects reported with Cymbalta include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. Other serious side effects include liver damage, allergic reactions such as hives, rashes and/or swelling of the face, pneumonia, depressed mood, suicide, suicidal thoughts and behavior.

While these serious side effects have been associated with the use of Cymbalta, they have occurred in less than 1% of treated patients. There are a finite number of drugs available for the treatment of chronic musculoskeletal pain, all of which are associated with rare, serious side effects. There are patients in whom none of the available treatments are effective.  

The recommended dose for Cymbalta is a 60 milligram capsule taken once daily without regard to meals. The capsule should be swallowed whole, and not chewed, crushed or opened; the contents should never be sprinkled on food or mixed with liquids.

Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at

Cymbalta is manufactured by Indianapolis-based Eli Lilly and Co.

For more information:

Approved Drugs: Questions and Answers

Media Inquiries: Shelly Burgess, 301-796-4651,

Consumer Inquiries: 888-INFO-FDA


SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Clears Software Upgrade for Fenwal Plasma-Collection System
2. FDA Clears AirStrip RPM for CRITICAL CARE & CARDIOLOGY Remote Patient Monitoring Solutions
3. FDA Clears Xlumenas NAVIX(TM) Access Device
4. FDA Clears Three Additional Antimicrobials for Use on TREK Sensititre(R) In Vitro Diagnostic (IVD) MIC Susceptibility Plates: Minocycline and Telavancin Used to Treat MRSA and Other Infections; and Tigecycline, Now Cleared for Streptococcus Pneumoni
5. FDA Clears the Fenwal Amicus(R) Separator System for Collecting Platelets in New Additive Solution
6. FDA Grants Cequent IND - Clears Way for First-Ever Clinical Trial of Orally Delivered RNAi Therapeutic: CEQ508, a tkRNAi Drug Candidate in Oncology
7. FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets
8. U.S. Food and Drug Administration Clears Alcatel-Lucent Remote Patient Monitoring Solution for Sale in the United States
9. Private Investment Firm Czura Thornton Today Introduces Clearstone Central Laboratories as the Newest Member of the Czura Thornton Life Science Group
10. FDA Clears a Test for Ovarian Cancer
11. U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies SUPERA Peripheral Stent
Post Your Comments:
(Date:11/30/2015)... Nov. 30, 2015 Oramed Pharmaceuticals Inc. (NASDAQ: ... the development of oral drug delivery systems, announced today ... at up to $50,000,000 with Hefei Tianhui Incubator of Technologies Co., Ltd. ... capsule, ORMD-0801, in China , ... . The agreements were signed at the Israel ...
(Date:11/30/2015)... 30, 2015 Cumberland Pharmaceuticals (CPIX), today announced that ... on December 3, 2015. TIME: 3:15p.m. ET ... ET LINK: --> DATE: ... --> --> ... are invited to ask the company questions in real-time - ...
(Date:11/30/2015)... Nuance Communications, Inc. (NASDAQ: NUAN ) and ... today jointly announced a new integrated set of clinical ... College of Radiology,s (ACR) Imaging 3.0™ tools to enable ... current and emerging value-based payment models . ... clinical decision support, radiology reporting and image sharing technology ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... , ... Scott Newman MD, FACS of New York’s Advanced ... in the New York City area to utilize the new, non-invasive SculpSure™ Laser ... treatment for fat loss in the abdomen, flanks, and other areas that is ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... GKhair & ... of the San Juan Beauty Show held on November 8th and 9th at the ... by media personalities, hair artists, renowned beauticians and top of the line fashion journalists. ...
(Date:11/30/2015)... (PRWEB) , ... November 30, ... ... ), a leading provider of enterprise Time and Attendance/Workforce Management cloud-based ... in the Microsoft Partner Program with competencies in the Application Development, demonstrating ...
(Date:11/30/2015)... , ... November 30, 2015 ... ... Inc. are pleased to announce their strategic partnership at the Radiological Society ... Transcription Service, Inc., and Winscribe, global providers of cutting-edge dictation and speech-enabled ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... dealer. Joining more than 30 HealthPostures’ dealers located throughout the United States, is ... the number of corporate, industrial, manufacturing and government workers and organizational leaders that ...
Breaking Medicine News(10 mins):