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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 19 of 19. This is the beginning of the thread.
Posted by Phillipa on August 20, 2010, at 20:15:12
Add to list chronic especially low back pain to list of uses for cymbalta, fibro and depression. Phillipa
From Medscape Medical News
FDA Panel Gives Mixed Blessing to Duloxetine for Chronic Pain
Fran LowryAugust 20, 2010 A US Food and Drug Administration (FDA) advisory committee has voted 8 to 6 in favor of Eli Lilly's request to broaden the indication for its antidepressant drug duloxetine (Cymbalta) to include the treatment of chronic pain.
The Anesthetic and Life Support Drugs Advisory Committee's marginal vote was a reflection of the ambiguity many members felt about the data presented by the sponsor in support of its request.
The panel felt that duloxetine was effective to treat chronic low back pain, showing its confidence by a vote of 8 to 5, with 1 panel member abstaining. But it voted 9 to 4, again with 1 abstention, against endorsing the drug for the treatment of osteoarthritis.
Already in use by 15 million people in the United States and approved to treat depression, diabetic nephropathy, and fibromyalgia, broadening the indication to include low back pain will likely result in a substantial increase in the prescribing of the product in the general population, "given the large number of Americans suffering from this type of chronic condition," Bob A. Rappaport, MD, director of the Division of Anesthesia and Analgesia Products of the FDA, reminded the panel.
Thomas Boyer, MD, from University of Arizona College of Medicine, Tucson, agreed that the data from the clinical trials presented by Lilly provided adequate evidence of efficacy for the management of chronic low back pain. He added that chronic low back pain "causes significant disability in the US and is poorly managed with the current pain medication."
Srinivasan Dasarathy, MD, from the Cleveland Clinic in Ohio, said he voted yes "because we should have some alternate treatments and duloxetine is not so bad."
Maria E. Suarez-Almazor, MD, PhD, from the University of Texas MD Anderson Cancer Center, Houston, agreed, adding that it is difficult to find alternative treatments for chronic low back pain.
There was some debate as to the different causes of low back pain and the degree of effectiveness of duloxetine given such variety, but Jeffrey R. Kirsch, MD, from Oregon Health & Science University, Portland, and chair of the panel, said he felt confident that a good relationship between physician and patient would allow for appropriate prescribing.
A dissenting vote came from Charles Rohde, MD, from Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, who said that the studies presented by Lilly were done mostly in whites and left out minorities. "There is ample evidence to suggest that certain minority populations do not follow the same patterns as a Caucasian population, and so by giving this a vote of yes, we would be saying it's fine for everyone and [I] don't believe that's been shown."
Gary Walco, MD, from Seattle Children's Hospital in Washington, who also voted no, added that the low back pain population is very heterogeneous and he would like to see more data on which patients would benefit the most from duloxetine.
Only 4 panel members felt that duloxetine showed benefit in the treatment of osteoarthritis.
Sorin Brull, MD, from Mayo Clinic College of Medicine, Jacksonville, Florida, was one. He said that the overall preponderance of the evidence suggested that duloxetine was at least as effective as the other available treatments for osteoarthritis and explained that his vote was based on noninferiority.
Dr. Boyer said he voted no because the 2 trials presented by Lilly were in conflict, with one showing positive results and the other showing negative results.
The panel was not too concerned about the drug's safety profile. Duloxetine is known to be hepatotoxic but so are a lot of other drugs. I would never prescribe anything if I was concerned about hepatotoxicity, said Dr. Dasarathy, a hepatologist. The hepatotoxicity with duloxetine is really not that bad.
All but 2 panel members felt that not enough evidence had been presented as to the safety of 120 mg of duloxetine in comparison with a 60-mg dose. But John Markman, MD, from the University of Rochester Medical Center in New York, disagreed.
"The evidence we say today does not strongly support the higher dose range, but I voted yes because in clinical practice there is enormous interindividual variation, and I do think there is a significant subpopulation who have incremental benefit over 60 mg, and I'd like to preserve access to that dose range for those patients," said Dr. Markman.
Dr. Dasarathy added that everyone increases the dose of a medication if it does not work. "Ultimately it is a decision of the physician and the patient."
Some panel members said they were concerned about the way that Eli Lilly has been marketing duloxetine, particularly on television. Dr. Kirsch told the FDA, "I think duloxetine will be a very useful drug for a significant number of patients and I think it's important to have it, but that said, I am personally perturbed by the marketing that goes on on television. The advertising ends with 'Depression is Painful'. I think that's an attempt of the sponsor to try to premarket this drug and for an indication that was not previously addressed until this point."
FDA Center for Drug Evaluation and Research Meeting of the Anesthetic and Life Support Drugs Advisory Committee, Bethesda, Maryland, August 19, 2010.
Posted by ed_uk2010 on August 21, 2010, at 10:34:15
In reply to Cymbalta approved by FDA for chronic pain, posted by Phillipa on August 20, 2010, at 20:15:12
No doubt we will see a large increase in the number of people complaining about withdrawal symptoms once the use of Cymbalta becomes more widespread.
How popular is Cymbalta in the US? It isn't used a great deal here. For neuropathic pain, amitriptyline is the most widely used treatment. Most people take 10mg to 50mg per day, sometimes more.
> Add to list chronic especially low back pain to list of uses for cymbalta, fibro and depression. Phillipa
>
> From Medscape Medical News
> FDA Panel Gives Mixed Blessing to Duloxetine for Chronic Pain
> Fran Lowry
>
> August 20, 2010 A US Food and Drug Administration (FDA) advisory committee has voted 8 to 6 in favor of Eli Lilly's request to broaden the indication for its antidepressant drug duloxetine (Cymbalta) to include the treatment of chronic pain.
>
> The Anesthetic and Life Support Drugs Advisory Committee's marginal vote was a reflection of the ambiguity many members felt about the data presented by the sponsor in support of its request.
>
> The panel felt that duloxetine was effective to treat chronic low back pain, showing its confidence by a vote of 8 to 5, with 1 panel member abstaining. But it voted 9 to 4, again with 1 abstention, against endorsing the drug for the treatment of osteoarthritis.
>
> Already in use by 15 million people in the United States and approved to treat depression, diabetic nephropathy, and fibromyalgia, broadening the indication to include low back pain will likely result in a substantial increase in the prescribing of the product in the general population, "given the large number of Americans suffering from this type of chronic condition," Bob A. Rappaport, MD, director of the Division of Anesthesia and Analgesia Products of the FDA, reminded the panel.
>
> Thomas Boyer, MD, from University of Arizona College of Medicine, Tucson, agreed that the data from the clinical trials presented by Lilly provided adequate evidence of efficacy for the management of chronic low back pain. He added that chronic low back pain "causes significant disability in the US and is poorly managed with the current pain medication."
>
> Srinivasan Dasarathy, MD, from the Cleveland Clinic in Ohio, said he voted yes "because we should have some alternate treatments and duloxetine is not so bad."
>
> Maria E. Suarez-Almazor, MD, PhD, from the University of Texas MD Anderson Cancer Center, Houston, agreed, adding that it is difficult to find alternative treatments for chronic low back pain.
>
> There was some debate as to the different causes of low back pain and the degree of effectiveness of duloxetine given such variety, but Jeffrey R. Kirsch, MD, from Oregon Health & Science University, Portland, and chair of the panel, said he felt confident that a good relationship between physician and patient would allow for appropriate prescribing.
>
> A dissenting vote came from Charles Rohde, MD, from Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, who said that the studies presented by Lilly were done mostly in whites and left out minorities. "There is ample evidence to suggest that certain minority populations do not follow the same patterns as a Caucasian population, and so by giving this a vote of yes, we would be saying it's fine for everyone and [I] don't believe that's been shown."
>
> Gary Walco, MD, from Seattle Children's Hospital in Washington, who also voted no, added that the low back pain population is very heterogeneous and he would like to see more data on which patients would benefit the most from duloxetine.
>
> Only 4 panel members felt that duloxetine showed benefit in the treatment of osteoarthritis.
>
> Sorin Brull, MD, from Mayo Clinic College of Medicine, Jacksonville, Florida, was one. He said that the overall preponderance of the evidence suggested that duloxetine was at least as effective as the other available treatments for osteoarthritis and explained that his vote was based on noninferiority.
>
> Dr. Boyer said he voted no because the 2 trials presented by Lilly were in conflict, with one showing positive results and the other showing negative results.
>
> The panel was not too concerned about the drug's safety profile. Duloxetine is known to be hepatotoxic but so are a lot of other drugs. I would never prescribe anything if I was concerned about hepatotoxicity, said Dr. Dasarathy, a hepatologist. The hepatotoxicity with duloxetine is really not that bad.
>
> All but 2 panel members felt that not enough evidence had been presented as to the safety of 120 mg of duloxetine in comparison with a 60-mg dose. But John Markman, MD, from the University of Rochester Medical Center in New York, disagreed.
>
> "The evidence we say today does not strongly support the higher dose range, but I voted yes because in clinical practice there is enormous interindividual variation, and I do think there is a significant subpopulation who have incremental benefit over 60 mg, and I'd like to preserve access to that dose range for those patients," said Dr. Markman.
>
> Dr. Dasarathy added that everyone increases the dose of a medication if it does not work. "Ultimately it is a decision of the physician and the patient."
>
> Some panel members said they were concerned about the way that Eli Lilly has been marketing duloxetine, particularly on television. Dr. Kirsch told the FDA, "I think duloxetine will be a very useful drug for a significant number of patients and I think it's important to have it, but that said, I am personally perturbed by the marketing that goes on on television. The advertising ends with 'Depression is Painful'. I think that's an attempt of the sponsor to try to premarket this drug and for an indication that was not previously addressed until this point."
>
> FDA Center for Drug Evaluation and Research Meeting of the Anesthetic and Life Support Drugs Advisory Committee, Bethesda, Maryland, August 19, 2010.
>
Posted by simcha on August 21, 2010, at 19:55:35
In reply to Re: Cymbalta approved by FDA for chronic pain » Phillipa, posted by ed_uk2010 on August 21, 2010, at 10:34:15
I'm not sure why this bugs me, but it does. It just infuriates me that our War on Drugs in the US makes treating chronic pain 1000 times more difficult. I've been on Cymbalta for years and was originally put on it because they thought that not only would it be a good anti-depressant for me, but it would take care of my alleged Fibromyalgia pain. I have to say that it's done nothing for my aches and pains. I still have back pain, for apparently no good reason. And I've been on Cymbalta for years. The only classes of meds that has ever worked for my back pain has been opiates or opioids. I only take Vicodin when I have a flare up that becomes debilitating (which is rare). I used to take Neurontin for similar reasons. It allegedly helps with pain. All it did for me is make me gain weight. It didn't even help with my restless legs as the doc promised. I had to fight to get put back on clonazepam, which continues to stop my restless legs without having to increase the dose. I'm on 0.5mg per night and I'm allowed to go as high as 1mg. It's very rare that I take the 1mg dose. I go that high maybe three times per month.
Lyrica was once mentioned to me and I refused. I'm glad I did because my Mom was put on it for alleged Fibromyalgia and all it did was make her gain weight. It never touched her pain. However, she doesn't do well on opiates or opioids so she relies on heavy doses of Aleve and ice packs. And she may not even have Fibromyalgia. She's getting more tests and who knows what they will decide she has next?
I believe that these meds get approved for pain because docs are afraid to prescribe opiates or opioids when they are indicated due to the pressure from the DEA in fighting its War on Drugs. I believe that our FDA is in on the whole thing too. For me, these alleged "pain meds" which are really anti-convulsants and anti-depressants aren't worth spit.
I'm annoyed that Ely Lilly gets to push Cymbalta (which seems to be useless to me as an anti-depressant. all I get from it is increased heart rate and sweating as far as I can tell) on a whole new group of people who need relief but won't get it while they make big $$$ on a drug that won't help them.
This is my opinion and isn't intended to negate other people's experience or to be construed as medical advice.
Posted by Phillipa on August 21, 2010, at 20:08:55
In reply to Re: Cymbalta approved by FDA for chronic pain, posted by simcha on August 21, 2010, at 19:55:35
To answer you both first Ed everytime I do a google search or go into newsletters there is cymbalta again. So yes it is popular. For me it did nothing anxiety/depression wise but did hide back pain. Now about the fibro and opiods I do agree can't get them even hard after surgeries. Phillipa
Posted by linkadge on August 22, 2010, at 12:39:03
In reply to Re: Cymbalta approved by FDA for chronic pain, posted by simcha on August 21, 2010, at 19:55:35
Some people do well on agents like Cymbalta for pain - especially if the pain is of nonspecific origin or psychosomatic.
However, I think the TCA's have more analgesic effects namely direct opioid receptor interaction, calcium channel blockade and NMDA antagonism.
I do agree with you, that for some people there is a lot of flaking around with agents that don't get to the point for pain. As well, agents like cymbalta are not without dependance potential.
It also depends on the source of the pain too. My father had back pain that was unsucessfully treated with opiates. Ultimatley celabrex provided the best pain relief.
Linkadge
Posted by ed_uk2010 on August 22, 2010, at 16:00:43
In reply to Re: Cymbalta approved by FDA for chronic pain, posted by linkadge on August 22, 2010, at 12:39:03
>Ultimately, Celebrex provided the best pain relief.
For some types of pain, NSAIDs such as Celebrex are more effective and more consistent than opioids.
Amitriptyline is at least 100 times more widely used than Cymbalta over here (for chronic neuropathic pain).
Posted by sigismund on August 22, 2010, at 16:11:43
In reply to Re: Cymbalta approved by FDA for chronic pain » linkadge, posted by ed_uk2010 on August 22, 2010, at 16:00:43
Most people with chronic pain put up with it knowing that it is not worth asking a doctor to help. It's supposed to be about 1 in 20 people here.
If you are really desperate it is easier to organise it yourself.
Posted by simcha on August 22, 2010, at 16:48:14
In reply to Re: Cymbalta approved by FDA for chronic pain, posted by sigismund on August 22, 2010, at 16:11:43
Yes, I give up on getting my pain properly treated because there really is nothing that docs seem to be able to do about it on a consistent basis.
I do go in when I have a huge flare-up though. And it takes an exceptional flare-up for me to have the will to go in and see a doctor. These days they give me a Toradol shot (anti-inflammatory) and vicodin. The last time it was so bad they added prednisone and valium. I had a herniated disk in my neck. Believe me, I was on Cymbalta and it didn't even touch the pain I was in. I was crying in my car driving home after putting up with the excruciating pain, numbness, and tingling for a week or two. I pulled over and called an advice nurse for my health plan and she convinced me to go to the emergency room. I was having numbness in my right arm and hand, radiating pain, and tingling. I still have occasional numbness in my right hand. They told me that I might have some residual nerve damage, lovely.
Our medical system in this country is terrible at treating chronic pain and some of the physical issues causing it. I've given up on having my daily pain treated. I'm used to it now.
Posted by sigismund on August 22, 2010, at 18:30:04
In reply to Re: Cymbalta approved by FDA for chronic pain » sigismund, posted by simcha on August 22, 2010, at 16:48:14
You have my sympathies (which is about all you're likely to get).
I had a ruptured disc in my lumbar spine, a long time ago now.
I do Pilates and similar stuff religiously......it has given me some resilience.
Posted by ed_uk2010 on August 23, 2010, at 14:15:12
In reply to Re: Cymbalta approved by FDA for chronic pain » sigismund, posted by simcha on August 22, 2010, at 16:48:14
>I've given up on having my daily pain treated. I'm used to it now.
Don't you get any regular treatment for it at all Simcha?
I guess the options are limited. Amitriptyline is often used but it interacts with sotalol. I believe you've already tried gabapentin and Lyrica.
I'm not a fan of Toradol, by the way. It has similar efficacy to most NSAIDs (at an adequate dose) but its toxicity is remarkably high in comparison. Toradol (either injection or tablets) can ulcerate the stomach very quickly. It can also cause renal impairment. Definitely one of the least safe NSAIDs ever marketed!
You have my sympathy too, although I guess my sympathy doesn't help too much.
Posted by simcha on August 23, 2010, at 18:27:56
In reply to Re: Cymbalta approved by FDA for chronic pain » simcha, posted by ed_uk2010 on August 23, 2010, at 14:15:12
ed_uk2010, thanks for the comment. My background pain has become familiar and I've learned to tune it out most of the time. I have a very high tolerance for pain as a result. This helps me manage well enough, so it can be an advantage. However, my very high tolerance for pain can prevent me from going to seek medical help when I should sometimes.
I always promise I won't wait as long to go to the doctor for the next flare up just as I get relief from going to the doctor for the current flare up. Then, I forget and fight going to the doctor, because I get frustrated at hearing the same old thing every time. There's really nothing that can be done when they don't know exactly what's causing the pain between flare ups.
Honestly, I have to say that probably most people deal with some level of pain every day once they reach a certain age. I know I'm not alone. Sometimes it scares me because I see my Mom deteriorating and having more frequent flare ups as she ages. She's tough. At the moment, she's getting treatment for a flare up. She's doing better. She has it worse because she has had 4 discs removed from her spine and she always has a few bulging discs. And she has permenant nerve damage that they can't fully explain.
I'm better at 40 than she was at 40 and I've not needed any surgery, so I'm very hopeful. Sometimes pain helps me to focus. It's a reminder to take better care of myself (when I listen to it). And I know I should exercise more, because it usually helps when I'm gentle about it.
So, if my background pain gets worse, then I will try to go to a pain clinic again and try all the things they throw at me like I have before. For now, it's manageable.
And, yes, my pain can make me crabby and it affects my mood sometimes. It can trigger a depressive episode. I do seek treatment when I notice this happening.
Thanks for everyone's concern, I didn't mean to make this thread about me and my pain. I just couldn't believe the strong reaction I had to learning that Cymbalta is being approved for chronic pain.
Posted by emmanuel98 on August 23, 2010, at 21:02:33
In reply to Re: Cymbalta approved by FDA for chronic pain » simcha, posted by ed_uk2010 on August 23, 2010, at 14:15:12
I agree with Ed about the Toradol. My dentist prescribed it for two weeks when I got a dry socket after having a tooth pulled. By day three, the gastritis was so bad, I needed to take a prilosec with every dose and it didn't work any better than ibuprofen.
Posted by ed_uk2010 on August 24, 2010, at 15:35:58
In reply to Re: Cymbalta approved by FDA for chronic pain » ed_uk2010, posted by simcha on August 23, 2010, at 18:27:56
>Thanks for everyone's concern, I didn't mean to make this thread about me and my pain. I just couldn't believe the strong reaction I had to learning that Cymbalta is being approved for chronic pain.
It's OK. It's good to have strong reactions sometimes :)
Posted by sigismund on August 24, 2010, at 22:30:11
In reply to Re: Cymbalta approved by FDA for chronic pain » simcha, posted by ed_uk2010 on August 23, 2010, at 14:15:12
>I'm not a fan of Toradol, by the way. It has similar efficacy to most NSAIDs (at an adequate dose) but its toxicity is remarkably high in comparison. Toradol (either injection or tablets) can ulcerate the stomach very quickly. It can also cause renal impairment. Definitely one of the least safe NSAIDs ever marketed!
I don't bother with NSAIDs. I keep my arthritis in line with boswellia and the usual hundred other natural anti-inflammatories that the medical profession assures us are unproven. If I had bad back pain I still wouldn't bother with them. Chronic pain requires treatment that is relatively benign (like opiates!) or none at all. TCM has more effective painkillers than the 30mg codeine/gutrot formulations available to the riffraff.
Posted by ed_uk2010 on August 25, 2010, at 14:21:19
In reply to Re: Cymbalta approved by FDA for chronic pain, posted by sigismund on August 24, 2010, at 22:30:11
>TCM has more effective painkillers than the 30mg codeine/gutrot formulations available to the riffraff.
I dunno. Codeine is not very effective for arthritis pain. NSAIDs are often useful though. If I was in a lot of pain, I would take an NSAID.
Posted by RocketMan on August 25, 2010, at 14:32:16
In reply to Cymbalta approved by FDA for chronic pain, posted by Phillipa on August 20, 2010, at 20:15:12
My wife started cymbalta 3 weeks ago for chronic pain. The results have been nothing short of a miracle. Works mich better than amitriptyline, lyrica, or even tramadol.
Posted by simcha on August 25, 2010, at 16:27:46
In reply to Re: Cymbalta approved by FDA for chronic pain, posted by RocketMan on August 25, 2010, at 14:32:16
I'm glad it works for her. I hope it continues to work. That's exciting if it's giving her relief from chronic pain. Good luck. :)
Posted by sigismund on August 27, 2010, at 19:51:22
In reply to Re: Cymbalta approved by FDA for chronic pain, posted by ed_uk2010 on August 25, 2010, at 14:21:19
> dunno. Codeine is not very effective for arthritis pain.
Ed, codeine just transfers the pain from wherever to your gut. The pain you get rid of (at best) for a little while and the pain from my gut will last longer than that
>NSAIDs are often useful though. If I was in a lot of pain, I would take an NSAID.What if the pain is continuous? Not so useful then. About as useful as a hole in the gut. Typical pharmaceutical products. They had better 2,000 years ago (Frankinsence).
Posted by ed_uk2010 on August 28, 2010, at 13:52:12
In reply to Re: Cymbalta approved by FDA for chronic pain » ed_uk2010, posted by sigismund on August 27, 2010, at 19:51:22
>What if the pain is continuous? Not so useful then. About as useful as a hole in the gut.
I would probably take naproxen + a proton pump inhibitor to protect the stomach. This normally helps, and the risk of GI adverse reactions is then low.
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