New article about Cymbalta

New Topic Post Reply Printable Version
[ << Previous Thread | Next Thread >> ]

mrsm123
Veteran Member


Date Joined Dec 2007
Total Posts : 1228
   Posted 8/17/2010 10:52 PM (GMT -7)   

I hope that posting this isn't going to get me in trouble but I really thought that it was relevant to us, and we all need to see it, especially those of us who take cymbalta for chronic pain or depression.

Sandi

 

Cymbalta Seeks Approval to Treat Chronic Pain, FDA Questions Safety

 

Categories: News

Federal health scientists are questioning whether the antidepressant Cymbalta is safe and effective enough to be approved for use against chronic pain.

The Food and Drug Administration on Tuesday posted its review of Eli Lilly and Co.'s application to market the drug for a range of pain ailments, including lower back pain. But FDA reviewers appeared cautious about further expanding use of a powerful psychiatric drug already used by nearly 15 million patients.

FDA reviewers raised questions about the statistical methods used to study the drug and its liver side effects.

The drug is already approved to treat depression, diabetic nerve pain and fibromyalgia.

The FDA will ask a panel of outside experts on Thursday to consider whether Cymbalta should be approved for chronic pain.

Eli Lilly has been trying to gain approval for the new indication for more than two years. The company withdrew its FDA application in November 2008 after agency evaluators questioned the method and design of some of the company's trials. The company resubmitted its application last summer with new data on Cymbalta's use against pain caused by osteoarthritis.

Three studies submitted by Lilly showed that Cymbalta lowered patient-reported pain scores significantly more than placebo after three months.

But in its review posted online, FDA scientists said Lilly's methodology still appeared "problematic." Specifically, the company included positive feedback data from patients who later dropped out of the study, possibly because of side effects to the drug. According to FDA reviewers, this practice could "potentially assign good pain scores to subjects who could not tolerate the drug."

The FDA also has concerns about widening use of a drug associated with serious liver toxicity. Cymbalta already carries a warning label about liver toxicity risks based on more than a dozen reports from patients taking the drug.

According to FDA records, use of Cymbalta has already expanded threefold - from 5 million in 2005 to 14.6 million last year - as the drug has picked up additional indications.

The agency will ask its panel of advisers to discuss the safety of further expanding the drug's use. The FDA is not required to follow the group's advice, though it often does.

Cymbalta is part of a class of drug called serotonin-norepinephrine reuptake inhibitors, which include antidepressants Effexor and Pristiq. If approved, it would be the first antidepressant cleared for chronic pain.

The drug was Eli Lilly's second best seller last year with sales of $3 billion, behind the anti-psychotic Zyprexa.

Copyright 2010 The Associated Press.

 
 

PLIF/TLIF Fusion w/Instrumentation L4-5 Spondololysthesis L4-5.Laminectomies L4-5, foraminal stenosis L3-4, L4-5, L5-S1, herniations L3-4, L4-5, L5-S1, central canal stenosis L3-4, L4-5 and L5-S1
POST OP CES 3/30-06
Neurogenic Bladder and Bowel, bilateral numbness legs and feet
Revision for failed Back surgery, pseudoarthrosis L4-5, hemilaminectomies L3-4, L4-5, L5-S1, bmp added to revision fusion, replaced two bent screws that were reversing out of vertebrae - August 2, 2007
On going back pain and neuropathic pain, failed back surgery, consult for scs, decided not to do that at this point.
Adhesive Arachnoiditis also......just what I didn't need..9/08- adding bilateral ulnar neuropathy with severe compression to the mix. They want me to see a surgeon for ulnar nerve surgery, but I'm not biting.
I've seen enough surgeons over the last few years.
Avascular necrosis of left wrist- maybe hips too

Blessedx8
Veteran Member


Date Joined Aug 2008
Total Posts : 3193
   Posted 8/18/2010 12:05 AM (GMT -7)   
Sandi...

Great article :) --I don't take cymbalta but I think several people on here do.

I mainly just wanted to say hi and that it's great to see you here, my friend!

Love, Tina

PAlady
Veteran Member


Date Joined Nov 2007
Total Posts : 6795
   Posted 8/18/2010 12:46 AM (GMT -7)   
Sandi,
Thanks for the article. I've tried cymbalta and may be trying it once more as it did help quite a bit with the neuropathy in my feet, but I also had one adverse reaction. My new PM thinks it's worth another try and I agree, especially since I'm not working anymore and can change back to effexor if needed. But I'd be using it for one of the "on label" conditions (actually, 2 of them). Not sure about its broader use for CP, especially if other medications that don't affect the liver as much are equally or more helpful.

I'm just rambling. But I am glad to see you posting again! Missed you!

PaLady

Jim1969
Veteran Member


Date Joined Jul 2009
Total Posts : 2042
   Posted 8/18/2010 7:18 AM (GMT -7)   
I have been taking Cymbalta for years for my diabetic nueropathy and it has worked wonders for that, but it has done nothing for my back pain. I know this because I have had to go off it twice due to financial reasons and my back pain did not get any worse.
2 confirmed herniated lumbar discs. Spinal Arthritis. Spinal Stenosis, diabetic peripheral nueropathy.

mama6
Regular Member


Date Joined Jul 2010
Total Posts : 416
   Posted 8/18/2010 8:44 AM (GMT -7)   
Good article, thaks. I take cymbalta and hate it. It doesn't work for my pain at any level. Or I might say if it is then it's not worth *** on a bullfrog...sorry all I could relate it to. The side effects are horrid, trying to get off of it has been a nightmare. I know it has worked for some, but not me and I have even worse side effects with Lyrica
Big Hugs, Mama6

DX. with Fibromyalgia, Narcolepsy, Poss. RA or Psoratic Arthritis, Herniated disc 3x in last 7 months
Meds: Nuvigl, Cymbalta, Tramadol

Mother to 5 wonderfull kids. Oldest is 18 and just left the nest for animation school. Youngest just started 2nd grade. So I am crazy, and feeling my age plus some.

antbuggey
Veteran Member


Date Joined May 2010
Total Posts : 594
   Posted 8/18/2010 9:12 AM (GMT -7)   
Thanks for posting this! I used Cymbalta in the past and felt like it worked miracles! Was off of it for a while and now I am back on it. This time it feels like it is helping with the nerve pain some.....but that is about it! My back seems like it is worse then ever and my depression... let's just say VERY bad! I am not sure if the back pain is worse because of the onset of RA, because they have not confirmed it yet.....and I know the depression is worse because of how bad I feel and the not knowing! I am not ready to give up on cymbalta yet, and who knows... maybe they will get the other stuff figured out and it will work better!

Wishing everyone a LPD!
Spinal Stenosis L3/L4, L4/L5 & L5/S1 with Nerve Impingement, Fibromyalgia, TMJ, GERD, Severe Depression, VERY Large Cyst Right Ovary causing mild twisting, Small Cysts Left Ovary & 3 Large Cysts Uterus and Possible RA

Medications - MS-Contin, Cymbalta, Famotidine and currently Prednisone

mrsm123
Veteran Member


Date Joined Dec 2007
Total Posts : 1228
   Posted 8/18/2010 1:14 PM (GMT -7)   
Hi Momto6boys,
It's good to see you too! How are you feeling? I read the last update and responded, hope that you got it.
I tried Cymbalta twice and it didn't do anything for me, and the side effects were really bad for me as well. It was one of the three meds that I tried that I just couldn't deal with the side effects of.
I know that it works really well for some people and others, not so well, if at all. It is like every other medication out there, it will work fantastically well for one and for the next person, it's a bust.
Ah well, I just wanted those of us here , who take it to see the article since it has important information that we all need to know if we're taking it or considering taking it.
I know of one woman that took over a year with tiny decreases in dosage to get off it, she had some pretty horrendous side effects , but so many others have none. I think though that the liver concerns really need to be kept watch of.
Anyway, hope this finds everyone having a decent day.
Sandi
PLIF/TLIF Fusion w/Instrumentation L4-5 Spondololysthesis L4-5.Laminectomies L4-5, foraminal stenosis L3-4, L4-5, L5-S1, herniations L3-4, L4-5, L5-S1, central canal stenosis L3-4, L4-5 and L5-S1
POST OP CES 3/30-06
Neurogenic Bladder and Bowel, bilateral numbness legs and feet
Revision for failed Back surgery, pseudoarthrosis L4-5, hemilaminectomies L3-4, L4-5, L5-S1, bmp added to revision fusion, replaced two bent screws that were reversing out of vertebrae - August 2, 2007
On going back pain and neuropathic pain, failed back surgery, consult for scs, decided not to do that at this point.
Adhesive Arachnoiditis also......just what I didn't need..9/08- adding bilateral ulnar neuropathy with severe compression to the mix. They want me to see a surgeon for ulnar nerve surgery, but I'm not biting.
I've seen enough surgeons over the last few years.
Avascular necrosis of left wrist- maybe hips too

mrsm123
Veteran Member


Date Joined Dec 2007
Total Posts : 1228
   Posted 8/18/2010 1:26 PM (GMT -7)   
Hi PA Lady!
How are you doing my friend? I hope as well as you can be for today. If you had side effects that caused you to stop taking it because they were significant before ,please be careful about going back on it , since an adverse reaction is usually worsened each time the exposure happens again to the medication or other substance.
I know that you will be, you are a careful consumer of medical care, so I have no doubt that you will check things out again before trying it. If there is another medication that offers similar relief, but with less side effects , it might be worthwhile giving that medication a try.
It is good to see you again too PA Lady, I've missed you also.
Sandi
PLIF/TLIF Fusion w/Instrumentation L4-5 Spondololysthesis L4-5.Laminectomies L4-5, foraminal stenosis L3-4, L4-5, L5-S1, herniations L3-4, L4-5, L5-S1, central canal stenosis L3-4, L4-5 and L5-S1
POST OP CES 3/30-06
Neurogenic Bladder and Bowel, bilateral numbness legs and feet
Revision for failed Back surgery, pseudoarthrosis L4-5, hemilaminectomies L3-4, L4-5, L5-S1, bmp added to revision fusion, replaced two bent screws that were reversing out of vertebrae - August 2, 2007
On going back pain and neuropathic pain, failed back surgery, consult for scs, decided not to do that at this point.
Adhesive Arachnoiditis also......just what I didn't need..9/08- adding bilateral ulnar neuropathy with severe compression to the mix. They want me to see a surgeon for ulnar nerve surgery, but I'm not biting.
I've seen enough surgeons over the last few years.
Avascular necrosis of left wrist- maybe hips too

mrsm123
Veteran Member


Date Joined Dec 2007
Total Posts : 1228
   Posted 8/18/2010 1:29 PM (GMT -7)   
Hi Jim,
It didn't do anything for my back pain either so that , along with the side effects made it so that there was no reason to continue it.
I think it's because like all of the other meds out there, one works really well with someone's body chemistry and with others, it conflicts or causes some reaction that is adverse so we have to stop taking it.
I wish that it had helped, I get tired of being in a pretty severe level of pain all of the time and I would take it again despite the side effects if it were of some help.
Sandi
PLIF/TLIF Fusion w/Instrumentation L4-5 Spondololysthesis L4-5.Laminectomies L4-5, foraminal stenosis L3-4, L4-5, L5-S1, herniations L3-4, L4-5, L5-S1, central canal stenosis L3-4, L4-5 and L5-S1
POST OP CES 3/30-06
Neurogenic Bladder and Bowel, bilateral numbness legs and feet
Revision for failed Back surgery, pseudoarthrosis L4-5, hemilaminectomies L3-4, L4-5, L5-S1, bmp added to revision fusion, replaced two bent screws that were reversing out of vertebrae - August 2, 2007
On going back pain and neuropathic pain, failed back surgery, consult for scs, decided not to do that at this point.
Adhesive Arachnoiditis also......just what I didn't need..9/08- adding bilateral ulnar neuropathy with severe compression to the mix. They want me to see a surgeon for ulnar nerve surgery, but I'm not biting.
I've seen enough surgeons over the last few years.
Avascular necrosis of left wrist- maybe hips too

mrsm123
Veteran Member


Date Joined Dec 2007
Total Posts : 1228
   Posted 8/18/2010 1:44 PM (GMT -7)   
Pebbles,
I do hope that it is helping with the back pain,and it is truly wise on your part and that of your doctors to stay on top of the blood work to make sure that things are fine.
We should all find the time to make sure that we do that, I know that I don't go see my PCP unless I need to and that's not a good thing but I just get so sick of doctors that I just don't want to see one more .....
Sandi
PLIF/TLIF Fusion w/Instrumentation L4-5 Spondololysthesis L4-5.Laminectomies L4-5, foraminal stenosis L3-4, L4-5, L5-S1, herniations L3-4, L4-5, L5-S1, central canal stenosis L3-4, L4-5 and L5-S1
POST OP CES 3/30-06
Neurogenic Bladder and Bowel, bilateral numbness legs and feet
Revision for failed Back surgery, pseudoarthrosis L4-5, hemilaminectomies L3-4, L4-5, L5-S1, bmp added to revision fusion, replaced two bent screws that were reversing out of vertebrae - August 2, 2007
On going back pain and neuropathic pain, failed back surgery, consult for scs, decided not to do that at this point.
Adhesive Arachnoiditis also......just what I didn't need..9/08- adding bilateral ulnar neuropathy with severe compression to the mix. They want me to see a surgeon for ulnar nerve surgery, but I'm not biting.
I've seen enough surgeons over the last few years.
Avascular necrosis of left wrist- maybe hips too

mrsm123
Veteran Member


Date Joined Dec 2007
Total Posts : 1228
   Posted 8/18/2010 1:51 PM (GMT -7)   
Hi Mama6,
I'm sorry that you are struggling with getting off it. I've read that some have had great difficulty with stopping the medication once they started it. Someone on another board also had great difficulty stopping it and found that lowering the dosage by grains rather than milligrams helped more with the withdrawal symptoms she was having but that is something that you should discuss with your doctor before trying.
I hope things improve for you and that you can find a medication that brings more relief and less side efffects.
Sandi
PLIF/TLIF Fusion w/Instrumentation L4-5 Spondololysthesis L4-5.Laminectomies L4-5, foraminal stenosis L3-4, L4-5, L5-S1, herniations L3-4, L4-5, L5-S1, central canal stenosis L3-4, L4-5 and L5-S1
POST OP CES 3/30-06
Neurogenic Bladder and Bowel, bilateral numbness legs and feet
Revision for failed Back surgery, pseudoarthrosis L4-5, hemilaminectomies L3-4, L4-5, L5-S1, bmp added to revision fusion, replaced two bent screws that were reversing out of vertebrae - August 2, 2007
On going back pain and neuropathic pain, failed back surgery, consult for scs, decided not to do that at this point.
Adhesive Arachnoiditis also......just what I didn't need..9/08- adding bilateral ulnar neuropathy with severe compression to the mix. They want me to see a surgeon for ulnar nerve surgery, but I'm not biting.
I've seen enough surgeons over the last few years.
Avascular necrosis of left wrist- maybe hips too

mrsm123
Veteran Member


Date Joined Dec 2007
Total Posts : 1228
   Posted 8/18/2010 1:57 PM (GMT -7)   
Cymbalta is supposed to help with the nerve pain so that is probably why you are getting some relief but not from the mechanical pain. I think that the news article makes it sound like it's going to help with the mechanical pain and I don't know of any medication that helps with that beyond the pain meds to mask it. Even those only offer a partial relief from the pain rather than complete.
Unfortunately, once you injure something, it is never truly the same again, there is always some residual ache, pain, twinge .
I hope that you get the answers you are waiting for soon. The "hurry up and wait" thing with doctors is enough to drive us all crazy at times.
Sandi
PLIF/TLIF Fusion w/Instrumentation L4-5 Spondololysthesis L4-5.Laminectomies L4-5, foraminal stenosis L3-4, L4-5, L5-S1, herniations L3-4, L4-5, L5-S1, central canal stenosis L3-4, L4-5 and L5-S1
POST OP CES 3/30-06
Neurogenic Bladder and Bowel, bilateral numbness legs and feet
Revision for failed Back surgery, pseudoarthrosis L4-5, hemilaminectomies L3-4, L4-5, L5-S1, bmp added to revision fusion, replaced two bent screws that were reversing out of vertebrae - August 2, 2007
On going back pain and neuropathic pain, failed back surgery, consult for scs, decided not to do that at this point.
Adhesive Arachnoiditis also......just what I didn't need..9/08- adding bilateral ulnar neuropathy with severe compression to the mix. They want me to see a surgeon for ulnar nerve surgery, but I'm not biting.
I've seen enough surgeons over the last few years.
Avascular necrosis of left wrist- maybe hips too

PAlady
Veteran Member


Date Joined Nov 2007
Total Posts : 6795
   Posted 8/18/2010 1:59 PM (GMT -7)   
Hi, Sandi,
You're right - I intend to be very careful about trying it again, but I have to say it's the only medication so far that enabled my feet to feel close to normal again, and that makes it worth another shot for me. The problem I had was it affected my seizure threshold (I also have a seizure disorder), and of course that's not acceptable. I had no other side effects - figures, eh? But my PM doc is also a psychiatrist, and I talked with him extensively about it and since I don't drive much anymore and don't work, I will be able to tell fairly quickly if it's going to cause problems, in which case I just return to the effexor. The 30mg of cymbalta helped my mood, but I had to go to the 60 mg to get the decrease in neuropathic symptoms, which is pretty much what the research states. However, it was the 60mg that also gave me some other problems. I didn't have another seizure, but had some indicators I didn't like. But since I've been taking effexor for awhile now, and they're similar classes, the psychiatrist (he has a subspecialty in neurology) thought my body may be more accustomed to it, but the decision to try it again was all mine. It would be worth it if it worked.

BTW my regular neurologist, who I've seen for decades for my seizure disorder, is also involved. He does blood work 2X/yr to check, among other things, liver enzymes. He used to do it only once a year, but since I've added all the CP meds he now does it more often, and then I send it to all my other docs. I think it's important for any of us on long term medications to keep tabs on our liver and other internal organs. My liver enzymes are actually still in the normal range, which is great as they used to be elevated but have improved.

Anyway, glad to see you back!

PaLady

Hello~Kitty
Veteran Member


Date Joined Jun 2005
Total Posts : 610
   Posted 8/18/2010 5:17 PM (GMT -7)   
I've been on Cymbalta for almost 2 years now, last month I got up to 90mgs daily, it really hasnt done much for my depression/anxiety, and very little for my fibro, and MAYBE a little bit towards my back pain, but it has done ALOT for my severe migraines. Actually I havent had a migraine in the 2 years that I've been taking it, which is just wonderful for me. And I've tried every other migraine med under the sun and none of them worked or barely worked. So I think if anything, maybe they should do trials on migraine control with Cymbalta.

Cymbalta has been the ONLY anti-D that I can handle, as other anti-Ds made me very ill from the side effects, I was actually scared to take them at all, but my doctor talked me into it, and to my surprise, I had really no side efects at all, it made me kinda sleepy the first few days of taking it and when I raise my dosage, but that's nothing.

The only thing that scares me about them approving Cymbalta for "chronic pain" is that I feel that it gives doctors another pill to prescribe for when they don't wanna deal with the patients in pain, it's like a fix-all pill....your back hurts? here take Cymbalta...Can't sleep at night from the pain? here take Cymbatla.......having body pains everywhere? here take Cymbalta.....Your dying? here take Cymbalta.....instead of them actually taking your pain seriously. I feel they do this already with Amitriptyline and a few others. Basically it just gives doctors another reason to not prescribe strong pain medications to the patients that really need them. Eventough I feel most of us with chronic pain need anti-Ds to help with the depression that comes along with chronic conditions like pain, and that Cymbalta does have it's place in the chronic pain world, I just feel that alot of doctors are gonna beleive that if it's FDA approved for chronic pain, then that's all one needs if they have chronic pain. I hope I'm making any sense....lol.

-hellokitty

Carmen~*~*~Chronic Pain Moderator

DX-Chronic Pain due to two freak car accidents, Pancreatic Divisum, Fibromyalgia, Asthma, Depression w/anxiety, Migraines, and Kids!!!

Meds- buprenorphene (Subutex) for chronic pain, Cymbalta, prilosec, Zyrtec, ProAir inhaler, and the best medication is my puppy, kitty, and 5 guinea pigs!!!

 


skeye
Veteran Member


Date Joined Mar 2008
Total Posts : 2976
   Posted 8/18/2010 8:36 PM (GMT -7)   
Thanks Sandi!

I was just thinking about you the other day & wondering how you were doing. I'm so glad to see that you posted.

As for the article, that was an interesting read. I was on Cymbalta about 3 1/2 yrs ago. I was originally started on in for depression (at 30 mg/day), and then after having no success with neurontin, my neurologist, and then my PM, increased it from 30 mg to 60 mg, to 90 mg. Unfortunately, it didn't help at all with my pain or depression & at 90 mg, actually made my depression much much worse, so I ended up coming off of it (which was a whole fiasco in itself, because regardless of slowly tapering off the med, I had some nasty side effects). I'm not a big fan of Cymbalta, just because of the negative effect that it had on me, however, I certainly do believe that it has the potential to help some people.

However, I also have to agree with Carmen, about being afraid that if Cymbalta is approved for CP, that it may be overused & used where not necessarily appropriate. However, I'm not sure that this isn't necessarily being done already -- regardless of FDA approval for CP. If you talk to anyone with CP, they'll most likely tell you that they are on Cymbalta, or were on it for pain at some point. In a way it almost seems like it's becoming a "right of passage" drug (as are drugs like amitriptyline & neurontin, like Carmen mention). Basically, if Cymbalta doesn't work, THEN you can try something else, but you have to try Cymbalta first. Yes, it is going to work for some people, and that is FANTASTIC, but I think that FDA approval may lead it to be used widespread, rather than for particular types of pain (ie neuropathic pain), like it has been shown to help with & that could be dangerous.

Skeye

Post Edited (skeye) : 8/18/2010 9:40:40 PM (GMT-6)

New Topic Post Reply Printable Version
Forum Information
Currently it is Saturday, December 10, 2016 11:11 PM (GMT -7)
There are a total of 2,736,221 posts in 301,362 threads.
View Active Threads


Who's Online
This forum has 151452 registered members. Please welcome our newest member, sarajseri.
206 Guest(s), 4 Registered Member(s) are currently online.  Details
c130j, bluelyme, jrpsf, julymorning


Follow HealingWell.com on Facebook  Follow HealingWell.com on Twitter  Follow HealingWell.com on Pinterest
Advertisement
Advertisement

©1996-2016 HealingWell.com LLC  All rights reserved.

Advertise | Privacy Policy & Disclaimer