The Food and Drug Administration has approved the anti-depressant Cymbalta for a different use: low back pain and osteoarthritis.
The drug, sold by Eli Lilly, has been used for the treatment of severe depression, anxiety, fibromyalgia and diabetic peripheral neuropathy. Now, low back pain and osteoarthritis will be added to the list.
Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, said
“ Up to three quarters of the population experience chronic pain at some time in their lives. This approval means that many of those people now have another treatment option.”
Initially it was approved in 2004 to treat only diabetic peripheral neuropathy and since that time, 30 million people in the USA have taken Cymbalta.
More than 600 patients with chronic back pain or osteoarthritis were studied during the clinical trial and the FDA say that compared with the placebo group, they had a significant reduction in their pain. However, they neglected to say what the placebo was.
Side-effects of the drug are:
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.
The FDA attempt to allay fears of the serious side-effects by saying that less than 1% of treated patients suffer serious side-effects. In real terms this means that for every 100 people taking Cymbalta, there could be one person becoming suicidal or having another type of serious effect.
They also say that all other drugs used to treat chronic back pain and osteoarthritis can also have serious side-effects.
There are some patients in which none of the drugs are effective at helping their condition.
If you are taking Cymbalta and you suffer an adverse effect, you can report it online at:
www.fda.gov/medwatch/how.htm
Source: FDA Press Release, 4th November 2010.
Joanna is a freelance health writer for The Mother magazine and Suite 101 with a column on infertility, http://infertility.suite101.com/. She is author of the book, 'Breast Milk: A Natural Immunisation,' and co-author of an educational resource on disabled parenting, in addition to running a charity for people damaged by vaccines or medical mistakes.