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How To Share Cymbalta Concerns With My Psychiatrist


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#1 Ereinion

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Posted 28 August 2017 - 06:15 PM

In early May 2017 I started weaning off Cymbalta/dulexotine by decreasing my dosage from 60 mg to 30 mg. Now, 3 months later, I still have many withdrawal side effects, and some are actually increasing. I recently contacted my psychiatrist to tell her this, and she doesn't seem to think that it is related to withdrawal, since it has been 3 months since the change, but she would like to see me in several days anyway.

 

Here's my question: what is the best way to share with her my struggle and get her to understand that it really is possible for this to still be withdrawal? If possible, I would like her to understand that not only would I like to eventually get off it completely, but that I would hope she could become much more cautious about prescribing it to anyone else. Unfortunately, I wonder if she won't believe that I'm still having side effects, or that withdrawal problems are very widespread. 

 

I know most doctors are leery about information that people have read on the web, for good reason, but that doesn't mean that it is all untrue, and I have found tons of sites with information about how bad Cymbalta withdrawal can be. How can I get her to realize this without sounding like a conspiracy theorist?


#2 fishinghat

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Posted 29 August 2017 - 09:08 AM

I have a couple documents that I will post links to in a minute. They are from the FDA and the manufactures of Cymbalta. Maybe she will believe then.


#3 fishinghat

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Posted 29 August 2017 - 09:29 AM

I would print off both documents and maybe highlight the areas of concern for her convenience.

http://www.fda.gov/d...e/UCM172866.pdf

The following document was issued by the FDA warning of the severity of Cymbalta Discontinuation Syndrome.

Page 1
Cymbalta (Duloxetine) Discontinuation Syndrome
Issues of Scope, Severity, Duration & Management
June 9, 2009

Page 3
The effects of discontinuation can be severe and extend for weeks or even months

Extreme mood swings (anger, irritability)
Debilitating “Brain Zaps”
Physical and neurological problems

Page 4

Claims
Cymbalta discontinuation syndrome is more severe and much more widespread than acknowledged by Eli-Lilly

⦁ Lilly sales representatives and marketing materials do not adequately inform physicians about the likelihood and severity of discontinuation syndrome

⦁ Lilly Direct to Consumer (DTC) advertizing is misleading related to the probability, severity and complexity of Cymbalta discontinuation

⦁ Lilly has not developed and fielded a clinically proven protocol for safely discontinuing Cymbalta

Page 8

⦁ 2) Lilly sales representatives and marketing materials do not adequately inform physicians about the likelihood and severity of Cymbalta discontinuation syndrome

⦁ Unaware physicians unable to discuss Cymbalta benefit-risk profile (including discontinuation) with their patients

⦁ Physicians can not make an accurate comparative assessment of Cymbalta vs. alternatives

⦁ Patients can not make an fully informed choice to take the drug

⦁ Practical effects (common in anecdotal reports):Patient becomes totally distrustful of the physician who did not advise/warn them in the first place

⦁ Doctor /patient relationship is wrecked

⦁ Patient in distress refuses to ingest Cymbalta under any pretext

⦁ Tapering is taken off the table

⦁ Patient fires the doctor or the doctor disengages from the patient

⦁ Syndrome mood swings militate anger directed at the physician

⦁ Physician may deny syndrome even exists

⦁ Physician may jettison a newly “difficult” patient

⦁ Physician seeks to avoid malpractice implications

⦁ Patient becomes deeply suspicious of any psychotropic medication

⦁ Underlying problem may go untreated

⦁ This is a process flaw – there is no excuse for it


Page 9

⦁ Lilly Direct to Consumer (DTC) advertizing is misleading related to the probability, severity and complexity of Cymbalta discontinuation

Also states that “opening the capsule is required to taper”

Page 14

⦁ Lilly does not offer small dose Cymbalta formulations to facilitate tapering Patient required to open capsules and count drug beads

⦁ Patient may require compounding pharmacy services at his/her expense

⦁ Tapering may take weeks or months



https://dailymed.nlm...f2-c185fbad64ba

Cymbalta Drug Insert

2.7 Discontinuing CYMBALTA
Adverse reactions after discontinuation of CYMBALTA, after abrupt or tapered discontinuation, include: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see Warnings and Precautions (5.7)].


Section 5.7

Patients should be monitored for these symptoms when discontinuing treatment with CYMBALTA. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate [see Dosage and Administration (2.7)].

Section - Dosage and Administration
Discontinuing CYMBALTA: Gradually reduce dosage to avoid discontinuation symptoms (2.7, 5.7)

Section - Warnings and Precautions
Discontinuation: May result in symptoms, including dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue (5.7)

6.12 Postmarketing Spontaneous Reports
The following adverse reactions have been identified during post approval use of CYMBALTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions reported since market introduction that were temporally related to CYMBALTA therapy and not mentioned elsewhere in labeling include: acute pancreatitis, anaphylactic reaction, aggression and anger (particularly early in treatment or after treatment discontinuation), angioneurotic edema, angle-closure glaucoma, colitis (microscopic or unspecified), cutaneous vasculitis (sometimes associated with systemic involvement), extrapyramidal disorder, galactorrhea, gynecological bleeding, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity, hypertensive crisis, muscle spasm, rash, restless legs syndrome, seizures upon treatment discontinuation, supraventricular arrhythmia, tinnitus (upon treatment discontinuation), trismus, and urticaria.

6. discontinuation symptoms: Do not stop Cymbalta without first talking to your healthcare provider. Stopping Cymbalta too quickly or changing from another antidepressant too quickly may result in serious symptoms including:
⦁ anxiety
⦁ irritability
⦁ feeling tired or problems sleeping
⦁ headache
⦁ sweating
⦁ dizziness
⦁ electric shock-like sensations
⦁ vomiting or nausea
⦁ diarrhea


#4 fishinghat

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Posted 29 August 2017 - 09:42 AM

A couple medical journal articles you can share with her.

 

http://www.aafp.org/.../0801/p449.html

It may be possible to discontinue medication more quickly if doses are low; discontinuation may take longer (three months or more) after maintenance therapy.

https://www.ncbi.nlm...ith agoraphobia

Discontinuation syndromes appeared to be fairly common even when performed with slow tapering and during clinical remission. In some cases disturbances persisted for months after discontinuation.


#5 fishinghat

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Posted 29 August 2017 - 10:09 AM

Another one...

Paroxetine (Paxil) and venlafaxine (Effexor) seem to be particularly difficult to discontinue and prolonged withdrawal syndrome lasting over 18 months have been reported with paroxetine. (See the following 3 references)

https://www.ncbi.nlm...pubmed/11347722
https://www.ncbi.nlm...pubmed/12008858
Gartlehner G, Hansen RA, Morgan LC, et al. (December 2011). "Results". Second-Generation Antidepressants in the Pharmacologic Treatment of Adult Depression: An Update of the 2007 Comparative Effectiveness Review (Report). Comparative Effectiveness Reviews. Rockville, MD: Agency for Healthcare Research and Quality – via NCBI Bookshelf.
 


#6 Ereinion

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Posted 30 August 2017 - 10:50 AM

This is wonderful! Thanks so much for all the information. I appreciate how thorough and helpful you are. If I may ask, how did you get so involved in this area?


#7 fishinghat

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Posted 30 August 2017 - 11:31 AM

Simple, I went through Cymbalta withdrawal, on this site, back in 2013. I had so much help from so many people that I decided to stay and repay the site for all it had done for me. I have a Master's in Physiology and was very familiar with doing medical literature for information and familiar with the biology involved so...I thought a perfect match. Always glad to help.


#8 Ereinion

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Posted 30 August 2017 - 01:41 PM

Thank you very much for giving back; it is great to have someone who has not only been there, but is also knowledgeable about the medical side of things. 

 

For some reason, though, I am getting an error message when I try to follow the link to the FDA article. I've tried searching their archives directly, and can't seem to find it there either. 

 

The message reads: 

Content Server Request Failed Unable to download 'UCM172866'. Unable to find latest released revision of 'UCM172866'.
Login ] 

 

Not sure if it is a link problem, or a problem with their site?


#9 fishinghat

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Posted 30 August 2017 - 02:37 PM

Hmmm, not good. I am having the same issue. I will keep working on it.


#10 fishinghat

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Posted 30 August 2017 - 06:03 PM

Wow, what a deal. I have tried everything I can think of and everything indicates that that document has been removed from their database. I think I know someone who has a copy of it so I will contact them tomorrow. Stay tuned.


#11 gail

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    5 months on cymbalta, scary side effects, to get help and to return the favor if I can.

Posted 31 August 2017 - 07:39 AM

Hi Ereinion,

You can Google FDA warning discontinuation cymbalta.

#12 Ereinion

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Posted 31 August 2017 - 10:39 AM

Hi Ereinion,

You can Google FDA warning discontinuation cymbalta.

I did do a Google search for that, and still am not able to find the specific document. I find many references to it in other sites and publications, but the actual document itself is proving to be elusive. 


#13 fishinghat

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Posted 31 August 2017 - 01:33 PM

Hi Ereinion,

 

I have contacted the FDA and they are having trouble finding that document but said they will contact me when they finish their search. I have also contacted a colleague in California who says  he may have a hard copy. He will let me know. I will keep working on it. I would like to have a copy for myself anyway.


#14 fishinghat

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Posted 31 August 2017 - 01:36 PM

I did find some slides that the fda prepared for a presentation on this document.

https://wayback.arch...e/UCM172866.pdf

#15 fishinghat

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Posted 31 August 2017 - 02:06 PM

That is basically the original document but the page numbers do not exactly match mine. All the information is there though. Print off the document including the cover page. Your dr shouldn't have any issue accepting this document.


#16 fishinghat

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Posted 31 August 2017 - 05:35 PM

By the way Ereinion, that drug insert link is a  National Institute of Health website (Gov.) but if you want the official FDA drug insert (identical) it can be found at https://www.accessda...0/022516lbl.pdf.


#17 kimmybc

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Posted 04 May 2018 - 03:33 AM

FH, were you able to get in contact with the FDA to have the document back up?

#18 fishinghat

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Posted 04 May 2018 - 08:42 AM

Hi Kimmybc

 

I did contact them and they will not be reposting the document but as it turns out the "wayback archive " link is a copy of the original document.





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