Navigation Links
FDA Clears Cymbalta to Treat Chronic Musculoskeletal Pain
Date:11/4/2010

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.  

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

"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 www.fda.gov/medwatch/how.htm.

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, shelly.burgess@fda.hhs.gov

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:
*Name:
*Comment:
*Email:
(Date:1/16/2017)... India , January 16, 2017 ... Market Research, titled, "Sterilization Technologies Market by Type and ... the global sterilization technologies market is expected to reach ... growing at a CAGR of 5.8% from 2016 to ... market in 2015, with more than half share, in ...
(Date:1/16/2017)... January 16, 2017 Bill is an internationally ... general management and leadership positions with global medical device companies, including ... track record of launching new products and building successful businesses in ... Africa and North America ... Educated at ...
(Date:1/16/2017)... , Jan. 16, 2017 CBDRx, the ... large amounts of phyto-nutrient rich hemp extract to Veteran,s ... donation of their proprietary hemp extract to Veteran,s groups ... the best hemp company in the world and through ... most nutritious, full spectrum phyto-nutrient rich hemp extract available. ...
Breaking Medicine Technology:
(Date:1/16/2017)... (PRWEB) , ... January 16, 2017 , ... San Francisco ... iTero Element, the latest in 3-D scanning device which is capable of taking digital ... latest advances in dentistry, such as CAD CAM restorations , in terms of ...
(Date:1/15/2017)... ... ... In this role, Courtney will be responsible for developing new business initiatives ... mark. This certification program was created by ASL and the nonprofit Asthma and Allergy ... for the 60+ million people living in the U.S. with asthma and allergies. Courtney ...
(Date:1/15/2017)... ... January 15, 2017 , ... Accreditation Commission for ... for its specialty care services. Albertsons Companies is the largest national food ... for pharmacy patients. , Accreditation by ACHC reflects Albertsons Companies’ dedication and commitment ...
(Date:1/15/2017)... ... January 14, 2017 , ... Wondering where to go ... delivered straight to your door for a romantic, lobster feast in the comfort of ... for Valentine's Day. The dinners will be featured until February 15th, 2017. , ...
(Date:1/14/2017)... ... January 14, 2017 , ... ... among their expanding line of activated charcoal products. With more and more people ... categorizing their products according to how they cater to specific needs. , Moody ...
Breaking Medicine News(10 mins):