CYMBALTA = ORAFLEX DE-JA-VU?
In an Oraflex de-ja-vu Cymbalta has just been approved in Canada for osteoarthritis pain. (See article below)
But what about the US? Cymbalta has long been approved in the US for many other conditions other than depression such as urinary incontinence, neuropathy, fibromyalgia, osteoarthritis, chronic low back pain, chronic musculoskeletal pain, etc.
What is Oraflex? The full Oraflex story is in the beginning of my book PROZAC: PANACEA OR PANDORA? – OUR SEROTONIN NIGHTMARE! (pgs. 56-57) Oraflex was another Eli Lilly drug approved years ago for arthritic pain. When the drug was approved by the FDA people were dying on Oraflex in Europe, but the drug manufacturer, Eli Lilly, the same manufacturer of Cymbalta, did not disclose to the FDA that patients taking Oraflex were dying in Europe.
So after Oraflex had been on the market in America for 2 months the reality set in about the dangers of Oraflex. At that point the drug was pulled & it was determined that at least 43 people had died as a direct result of the use of the pain killer for arthritis. And because Eli Lilly had not disclosed that they knew there were life threatening problems with Oraflex, Eli Lilly faced criminal charges for those deaths. They plead guilty to the criminal charges in August of 1985 which in my opinion would be the same as negligent homicide, and which I would call a form of premeditated murder. Were they jailed like any of us would be? Of course not! They were fined a whopping $20,000 for 43 American deaths (There were more in other countries)! There is basically no punishment for their crimes.
Will the Cymbalta scenario play out as the Oraflex nightmare did? No! It is clear that it will be FAR WORSE!!!! This drug is in a group of drugs known to produce suicide & homicide when you hit toxic levels. So not only will the patient die, but so will many of those around them. This is a very sad & very dangerous situation. Warn your family & neighbors – especially those who may be being treated for urinary incontinence, neuropathy, fibromyalgia, osteoarthritis, chronic low back pain, chronic musculoskeletal pain, etc. with yet another SNRI marketed in ways that most would never know that it is an antidepressant they are getting. (See Canadian article below)
Health Canada approves Cymbalta for the management of osteoarthritis knee pain
Once daily treatment a unique new option
TORONTO, Nov. 7, 2012 /CNW/ – Eli Lilly Canada announced that Health Canada has approved Cymbalta® (duloxetine hydrochloride) for the management of chronic pain associated with osteoarthritis (OA) of the knee, representing a new analgesic treatment option for patients suffering from the condition.
Cymbalta is the only serotonin and norepinephrine reuptake inhibitor (SNRI) approved in Canada for the management of chronic pain associated with OA of the knee. Other Cymbalta indications include: major depressive disorder, generalized anxiety disorder, neuropathic pain associated with diabetic peripheral neuropathy, pain associated with fibromyalgia and chronic low back pain.
“People with OA of the knee often experience debilitating pain and struggle to find an effective treatment without the safety or addiction concerns of other pain medications,” said Dr. Philip Baer, Chair of the Section on Rheumatology of the Ontario Medical Association. “This approval gives healthcare providers an important new option to help patients manage their pain so they can get back to doing the activities they enjoy.”
OA is a progressive disease that occurs when damaged joint tissues are unable to normally repair themselves, resulting in a breakdown of cartilage and bone. The most commonly affected joints are the hands and weight-bearing joints, including the knees, hips, feet and spine.
It is believed that Cymbalta helps enhance the body’s natural pain suppressing system by increasing the activity of serotonin and norepinephrine in the brain and spinal cord.
Safe and Effective
Taken once daily, the safety and efficacy of Cymbalta in the management of chronic pain associated with OA of the knee was established in two, randomized, double-blind, placebo-controlled clinical trials.
Patients randomized to Cymbalta or placebo in a 13-week clinical trial started treatment at a dose of 30mg once daily for one week, then increased to 60mg once daily. After seven weeks of treatment, patients with sub-optimal response to treatment (
In a 10-week, placebo-controlled, flexible-dose study, patients with OA pain of the knee, who had inadequate pain relief from an optimized dose of non-steroidal anti-inflammatory drug (NSAID) therapy for two weeks, received 60/120 mg/day of Cymbalta or placebo. After eight weeks of double-blind treatment, patients treated with Cymbalta added to NSAID experienced significantly greater pain reduction compared with placebo.
Furthermore, the studies also showed Cymbalta to be safe and well-tolerated. The most commonly observed adverse events in Cymbalta-treated OA patients included nausea, constipation, dry mouth, fatigue, diarrhea, abdominal pain, dizziness, insomnia, decreased appetite, and erectile dysfunction. Patients may take Cymbalta with or without food; however, food may help to reduce the incidence of initial nausea. The recommended starting dose for Cymbalta is 60mg per day.
Osteoarthritis in Canada
Osteoarthritis is the most common form of arthritis. In fact, one in eight Canadians live with it and almost everyone over 65 years of age has OA in at least one joint. Nearly 1 in 100 (or 300,000) Canadian adults (age 20+ years) have experienced at least moderate to severe pain due to OA.
Among all cases of OA, it is estimated that 40 per cent of patients have moderate to severe hip and/or knee OA.
About Eli Lilly Canada Inc.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. Eli Lilly Canada, headquartered in Toronto, Ontario, employs more than 500 people across the country. Additional information about Eli Lilly Canada can be found at www.lilly.ca.
® Registered trademark owned by Eli Lilly and Company; used under license.
i Lane NE, Brandt K, Hawker G, Peeva E, Schreyer E, Tsuji W, et al. OARSI-FDA initiative:
defining the disease state of osteoarthritis. Osteoarthritis Cartilage. 2011 May 19(5):478-82
Epub 2011 Mar 23
ii Living Well with Osteoarthritis, Knowing your Treatment Options
http://www.parl.ns.ca/rooms/healthroom/pdf/osteoarthritis.pdf. accessed: October 18, 2012
iii Cymbalta Product Monograph, Clinical Trials, Eli Lilly Canada, 2012
iv Cymbalta Product Monograph, Clinical Trials, Eli Lilly Canada, 2012
v Frakes EP, Risser RC, Hochberg MC, Wohlreich MM, et al. Duloxetine added to oral nonsteroidal anti-inflammatory drugs for treatment of knee pain due to osteoarthritis. Current Medical Research and Opinion, 2011: 27:12 2361-2372
vi Cymbalta Product Monograph, Clinical Trials, Eli Lilly Canada, 2012
vii Arthritis Network. Impact of Arthritis. http://www.arthritisnetwork.ca/downloads/20111022_Impact_of_arthritis.pdf. Accessed September 11, 2012.
SOURCE: Eli Lilly Canada Inc.
For further information:
Cohn & Wolfe
Eli Lilly Canada Inc.
About the Author: Ann Blake Tracy is the author of PROZAC: PANACEA OR PANDORA? –OUR SEROTONIN NIGHTMARE!, and the director of the International Coalition For Drug Awareness [www.drugawareness.org]. She has testified before the FDA and has testified as an expert in legal cases involving serotonergic medications since 1992.
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