May 29, 2008

Lilly Submits Cymbalta For Chronic Pain Indication

Eli Lilly today announced that it has submitted a supplemental new drug application to the FDA for Cymbalta, its newish blockbuster anti-depressant, for the treatment of chronic pain. The drug is already approved for treating depression and diabetic neuropathic pain, and racked up over $2 billion in sales last year, its third full year on the market.

The company did not announce results of chronic pain studies it was submitting to the FDA. Previously, some of Lilly's pain-treating claims for the drug have been challenged in academic papers as being wildly overstated. Personally, I don't know what to make of this new paradigm of anti-depressants to treat pain, except to say that I am fairly skeptical. But anything to keep the DEA happy in its attempt to keep doctors from using legitimate pain killers such as opiates and medical marijuana.

Posted by Philip Dawdy at May 29, 2008 09:59 AM
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In my limited personal experience with Cymbalta (half the recommended dosage when I took it), it did help with chronic pain. Then again, around the same time that I started Cymbalta, I also started to practice yoga regularly, and this latter change is more likely to have addressed my chronic pain problems, which were musculo-skeletal in origin. Let's just say that the Cymbalta made it possible for me to drag myself to yoga class in first place -- beyond that, I am not sure what it has done. And, by the way, withdrawal symptoms from Cymbalta are similar to some other nasty SSRI withdrawal symptoms, like those dreaded brain zaps.

Posted by: maria at May 29, 2008 12:44 PM

Another dump an anti-d on the chronic pain people because the "depression" isn't based on the reality that the doctor isn't prescribing adequate pain medication. Who cares if someone has a few extra pills and feels good when the current situation is to have people crippled and disabled due to pain levels. Address the pain and remove the depression and hopelessness.

Another stop and worthless bullshit treatment a person suffering in pain will have to go through before being "allowed" what should have been a first line choice. The amount of bullshit and suffering makes these people mental cases. The DEA hasn't been successful in anything they've done and now they've screwed up medicine even worse. Doctors are fearful of prescribing adequate medicine in case it triggers an "investigation" Who would want to risk going up the government on a witch hunt? Most people don't have enough spine before you add the risk of the livelihood into the mix.

Posted by: asdf at May 29, 2008 01:53 PM

As someone who took 120mg of Cymbalta daily for chronic pain, I can say that I would have been better off on placebo. Cymbalta alleviated none of my pain and caused a significant number of side effects, including weight gain.

Yoga, on the other hand, was much more effective.

I don't feel depressed, but I will say that I'm happier when I can talk effective medication that lets me go out to see a movie every so often as opposed to ineffective meds that destroy my libido, cause me to gain weight and do through several weeks of hell in withdrawal from them during which I suffered from brain zaps, vertigo, insomnia, etc. At least painkillers just made me feel like I had a nasty flu.

Fuck Lilly. There's a special place in Hell for those bastards and I hope it involves choking them on their products and then ignoring their complaints about side effects until you change their medication / dosage.

Posted by: Puckett at May 30, 2008 12:14 AM

"I don't know what to make of this new paradigm of anti-depressants to treat pain, except to say that I am fairly skeptical."

It's not a new paradigm at all. The tricyclic class of antidepressants have been used for chronic for a couple of decades. Amitriptyline (Elavil) is one in particular. You might want to check your facts more in the future instead of knee jerk dumping on all uses of psychotropic medications.

Posted by: cairn at May 30, 2008 03:37 AM

Yes, Elavil WAS used, but few pain management docs use it as anything other than a last-ditch effort due to its side effects. I had the best dreams of my life while I was taking it - until my fiancee woke me up because I had grabbed her wrists in my sleep and was hurting her because I was dreaming she had joined a cult and I wanted to get her out of it. My understanding is that vivid dreams and acting out on them while asleep is not uncommon.

Posted by: Puckett at May 30, 2008 08:36 AM

I've been on Cymbalta for almost a year. This is my fourth attempt at treatment, and my third drug. Like many others, I was first diagnosed with Generalized Anxiety Disorder, then depression secondary to the anxiety, and finally, Bipolar Type II. This has occurred from when I was about 25 until now, nine years later. I have also faithfully attempted therapy of multiple types.

While I was experiencing these mental issues, I developed a lethargy and fatigue that progressed to 'discomfort.' (I am hesitant to use the word "pain" to describe this sensation.) It was similar to the day after a hike or vigorous exercise. It sometimes woke me up when I was sleeping. The aches and soreness were constant, and were affecting my job and limiting my ability to enjoy life.

The only thing that has helped was the Cymbalta. I can now say that I am 100% ache and 'discomfort' free.

I am very cautious to discuss what may or may not help people in pain. No medical professional has ever been able to even offer a guess as to why an otherwise healthy, active, young women more or less suddenly developed a chronic-fatigue-type-syndrome. (My words.) I was worked up for thyroid disease, tick borne diseases, viral diseases, autoimmune disease, you name it. Add to that I work in biomedical research in New York for world renowned physicians and researchers, so I have greater access to high quality medical care than most.

My options were to stay in this state of constant discomfort, or try another antidepressant. I opted to try the drug. It would not have been close to appropriate to treat me with pain killers. (And, I've tried them via "self-medication." It only works momentarily, and then I would quickly get no relief.)

You cannot generalize and state that people in chronic pain will not benefit from this treatment. There are many causes for what we perceive as pain, and many of the pathways need to be better understood.

This may offer an atypical solution to someone who previously had no option.

And when you're in constant, life-altering pain: If a placebo works, so be it. Chronic pain has been shown to be disastrous on the body. With informed consent, the patient can decide whether they want to try it or not.

Posted by: Jo Ann at May 30, 2008 12:41 PM

In May the 26th 2007,I was taking cymbalta.I had been on (only) that antidepressant for about 11/2 months.I argued with my Doctor about how antidepressants affect me but he kept insisting.The day (26thof May) I took my dose and a few hours later started hearing voices.I went to my room and wrote a suicide letter to my 3 daughters and Mother,which I barely remember doing.The voices got clearer and I remember feeling like a zombie.I went to the cabinet and got out the 38 special like I was told to.I walked outside and shot myself right towards my heart,thank God it missed my heart but I died and was flown to the hospital where they massaged my heart back to beating.They took the artery out of my leg and put it to my heart.I am left with my left arm still numb and I have no use of my hand.I am getting injections in my neck monthly for the pain and now am on methadone for the pain.I am not even sure if I am on the correct site for this type of issue but can you tell me where to go if I'm not?Can someone tell me who to get in touch with about this damn DEVIL'S DRUG? I want INFO on how to sue the m-fuckers for almost taking my life.I can't even take care of my Grand daughter the way that I should.I am limited as far as using my left arm.Have they ever tried doing every day tasks with one arm? HELL NO!

Posted by: tonda at May 31, 2008 01:34 PM

tonda, oh you are on the right site alright. i'm sorry you had such a horrific awful thing happen on cymbalta. use the search box on this site for cymbalta and you'll find a lot to read.

Posted by: Stephany at May 31, 2008 04:54 PM

@ Posted by Philip Dawdy at May 29, 2008 09:59 AM

said

"I don't know what to make of this new paradigm of anti-depressants to treat pain, except to say that I am fairly skeptical."

I don't think there is anything new about using AD's for this indication. In my country amyltryptaline is commonly prescribed for peripheral neuropathy in diabetic patients.

Quite whether the indication is listed on the drugs P.I.L. is neither here nor there given that doctors are free here to prescribe it "off indication" if in their clinical judgements they think it might help.

Sara xxx

What might be new is listing the pain indication on the duloxitine (Cymbalta) P.I.L.

Posted by: sara at June 1, 2008 02:12 AM

Tonda,
Seeing stories like yours bring tears to my eyes.
Yes, I'm quite emotional and I cry and laugh easily.
It would be good to see them paying with money for they have no heart and only understand pain when there's money involved.
After all people are being put on this drugs not because they are good for their health.
We have an huge amount of data to be sure that at least SSRIs are poisons.
I've revisited Yahoo's group that was created on 2005 http://health.groups.yahoo.com/group/SSRIsex/
The moderator "Vornan19" made a good job collecting data from patients.
I'm appalled seeing children who perhaps will never have a normal sexual life.
This is one of the stories that you can find there:
"I was diagnosed with major depression at the age of 15. At the time my doctor decided to put me on paxil. After 2 months of annoying side effects and no real improvement, he swiched me to Celexa. Once again, 2 months later, I was switched, this time to Zoloft. After 3 weeks I become suicidal, and was put into an inpatient program. They slowly decreased my dosage until I was sent home. My mother insisted on holistic medicine paired with a therapist. After 2 years of this my depression was worsening. A new doctor suggested I go back on Zoloft, on a different dosage (100mg). 2 weeks later I noticed that I had no libido whatsoever, and no real emotion, good or bad. By week 4 I felt like a zombie, doing nothing but thinking about suicide. By the third month it had gotten so bad that it was interfering with daily life. My doctor pulled me off the medication immediately. Now, 2 years later, I still have no sex drive which is a source of constant frustration for me. I'm happy to have found this group, and hopefully someday I'll be able to enjoy sex like I used to."

15 years old!

"18 year old female diagnosed with depression at 16. low mood for most of childhood and teenage years. former self harmer, when my mother found out i'd been cutting she packed me off to my gp who put me on prozac for a few months, subsequently referred to child psychiatrist and psychologist who further messed...."

18 years old...
There are many stories, lots of side effects that last after people are out off these drugs.

They are creating a generation of people with serious problems.

Can't these greedy people at least spare the teenagers?

Now they are putting children on these drugs!

That's what at stake here!
People with serious problems.
I hope that some miserable people that come here to make useless comments have the decency to raise their miser cases someplace else.

Posted by: Ana at June 1, 2008 10:14 AM

Some researchers are trying to understand what has happened to the brain after being on a SSRI:

Paxil reduces the volume of the amygdala
Study showing that paxil reduces the size of the amygdala in adolescent patients with OCD
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14970831

Do Antidepressants Cure or Create Abnormal Brain States?

Joanna Moncrieff*, David Cohen

Funding: The authors received no funding to write this article.
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0030240&ct=1

These are some of the questions that patients have tried hard to bring out.
Some physicians heard their appeal.

It's all heartbreaking.
If it's not a crime putting children under these drugs I think the word must have another acceptation.

Posted by: Ana at June 1, 2008 10:29 AM

Sorry,
I made a mistake...
I've talked about children because I've just visited the post "Aussie Toddlers On Ritalin".
Here is the Cymbalta for chronic pain scandal.

The off-label scandal.


Posted by: Ana at June 1, 2008 10:39 AM

wow, that was an "eyefull". i just started cymbalta for rsd (a chronic pain condition), and have nothing good or bad to say about it yet. i have tried all kinds of meds since i was diagnosed over 10 years ago,incl anti-convulsants, opiates, anti-d's, and other pain meds, and the dx only came after i found a dr that didn't think i was just trying to get drugs. it seems that ALL meds have people that they work well for, and those who it created more pwoblems for. we are not exactly the same, esp in the brain, so it makes sense to me that meds might work for some, and not others. however, i find it hard to believe that the pharmeceutical co's don't know about more of the negative side effects when they put it on the market. everyone is in everyone elses pocket- that is what needs to change. informed conset is wonderful, but what if not all the info is given? how can that be "informed"?

Posted by: mariah at February 19, 2009 04:46 PM

I have been in chronic pain for four months (upper right abdomen). The doctors have not been able to find the cause of the pain and prescribed Elavil at first which made me tired and was told to use it at night and take Tylenol in the day because Advil was eating my stomach.

I had ended up taking anywhere from 20-30 Tylenol a day for almost 3 weeks (500mg for 10 days and 650mg extended relief for 3 days). I was then told this is very dangerous and could cause liver failure and should go to the ER. I did and they drew blood and gave me an IV of NAC which made me sick and told me not to take any Tylenol for 3 days and to follow up with my doctor.

I have been too afraid to take anything and been coping with the pain that just gets worse daily. I saw my doctor today and he gave me Cymbalta to deal with the pain.

I told my sister what has been happening and she said the way they treat me they sound like quacks. So I did a bit of research and found that Cymbalta was never approved to treat that type of pain. Not only that, but it can cause further liver damage in people who might be vulnerable (like someone who was just in the ER from an overdose of Tylenol).

I have not been able to get help from the doctors in the insurance network tied to the two big hospitals in Nashville. I tried to look for a new doctor associated with a different hospital, but the waiting list is so long.

I am at the point where I don't care if I just drop dead. I am NOT crazy. I am NOT imagining this pain. It keeps me up most nights. I feel it throbbing, stabbing, pulsing. At times, I feel a big knot in the area where my liver/gallbladder should be.

I just want the pain to stop and the doctors to stop treating me as if I am insane because they can't find anything.

Posted by: J Copeland at April 20, 2009 02:50 PM

J copeland:

Has anyone suggested an intercostal nerve block? A 5 min procedure where local anesthetic is injected where a rib meets the spine, just under the rib and deadens the nerve which runs under the rib from the spine to around your chest or upper abdomen. intercostal neuropathy is very painful, cause not always known, and a single injection has an immediate effect so it also diagnoses the condition. 2-3 more injections might be needed as followup if pain returns. Very simple and safe procedure. contact a pain management clinic for the procedure. They should have no problem trying it to drr if it works and it should not be very expensive (actually about $10 of supplies and the rest inflated fees). your symptoms are highly suggestive, especially if CTs, MRIs, gall bladder workeup, liver workup are all negative. Also cymbalta seem snot to affect this pain.

Posted by: GS at May 12, 2009 12:57 AM
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