February 25, 2009
By Sandra Thornton
After noticing a change in TV ads for Cymbalta, now only claiming to help with depression, I was led to do extensive research on the internet as well as using valuable input from my fellow victims of fibromyalgia, and what I found was appalling.
Per FDA requirements each potential drug requires three phases of testing. Phase I of testing assesses the safety and tolerability of the drug. Phase II tests the efficacy of the drug, and Phase III tests the effects from long-term use of the drug and builds on the findings of two previous phases to further evaluate safety and effectiveness. These three phases are long and grueling… The company then submits application to the FDA for approval, a process that can take up to 2 ½ years. It takes approximately an average of 12 years to get a new drug from the laboratory unto the pharmacy shelf.
Dr. Michael R. Clark, Director of the Chronic Pain Treatment Program of John Hopkins Medical Institution, stated clinical trials were done for 12 weeks and 15 weeks. Info provided on websites stated two pivotal 3 month clinical trials were done. NIH also refers to a 6 month study whereby 60/120 mg per day appears to be safe and efficacious in patients with fibromyalgia. In a fibromyalgia article dated 10/15/2004, U.S. News stated that in most tests Cymbalta improved the score of pain in participants. However, in one of the primary measures of pain there was no significant difference. Since trial lasted only 12 weeks, it is impossible to tell how well the drug would control treatment for a longer period of time.
Interestingly, Europe expresses negative views for Cymbalta as a treatment for fibromyalgia.
Lilly submitted a chronic pain application in the second quarter of 2008 for chronic osteoarthritis of knee pain and low back pain. In Indystar dated November 28, 2008, Lilly withdrew its application for Cymbalta for chronic pain, with plans to resubmit in first half of 2009.
Cymbalta has encountered problems all along, as noted December 20, 2007, stating pain treatment claims overstated. People were given Cymbalta for chronic low back problems and experienced no relief, but plenty of side effects including liver damage, agitation, thoughts of suicide and withdrawal symptoms. It was insinuated that this drug was needed due to doctors' reluctance to prescribe opiates. If ,in fact, this is true, then perhaps physicians need to have doctor-patient contract whereby a patient agrees to take pain medication as prescribed and any drug abuse negates prescribing any future pain meds.
I refer the reader to a Cymbalta side effects, ratings and patient comments website which indicates the horrifying condition the majority of 1121 patients are in due to ingestion of this drug, and they only gave Cymbalta a 3 in effectiveness for multiple conditions it was prescribed for.
I have had fibromyalgia for several years, which I consider to be a neuromuscular disorder. In February 2008 I was prescribed 30 mg of Cymbalta to take at bedtime for peripheral neuropathy. I got immediate relief for the neural aspect; however it did not give muscular chronic pain relief.
I contacted the FDA to ask if Lilly/FDA would be pulling approval for fibromyalgia treatment, since it was no longer being advertised. FDA stated they were not aware of withdrawing the fibromyalgia claim on this product. I was urged to report info to FDA MedWatch program, which I did.
In summary, there are a lot of red flags surrounding Lilly's Cymbalta claims for treatment of anything which they must be aware of with changing ad. Extra emphasis was put on liver damage after approval early on as side effect and FDA put it on med alert listing. It is always worrisome to note side effects to any medication; however, when side effects are changed and more added there is a huge problem, due in part to the fact that drug trials were too short, inconsistencies in results and pure greed to get it on market as fast as possible to rake in the big bucks. How could this drug help fibromyalgia if it is ineffective for chronic pain? Also, with all the suicides and deaths associated with taking Cymbalta in the trial period, how could this drug have even been approved? Eli Lilly and FDA need to be held accountable for all the damage this has done and remove this medication from the market. I feel that I must speak for the millions of people who are unable to have a voice because they are so incapacitated with their illnesses, as I have been in that boat also.
Author's Bio: I retired last year. I was a former work at home medical transcriptionist. I have fibromyalgia among other ailments and am very passionate about treatment of victims of this and drug companies trying to rip us off. I wish everyone knew about when having problem with taking particular drugs that they contact FDA MedWatch. FDA needs to be gutted and started over for safety of everyone. A few months ago I adopted a senior Maine Coon cat from humane society and my whole world has been turned upside down. I have had cats in my life for many years but this critter was a whole new experience.