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Study finds some Cymbalta withdrawal "severe and persistent"


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A non-profit organization chides the FDA about the dangers of stopping Cymbalta.

 

http://www.pharmalot.com/2012/10/just-like-that-trying-to-discontinue-cymbalta/

 

Just Like That? Trying To Discontinue Cymbalta

 

By Ed Silverman // October 8th, 2012 // 11:30 am

 

There has always been concern about discontinuing antidepressants and withdrawal symptoms. But a new analysis finds that anywhere from 44 percent to 50 percent of Cymbalta patients experienced withdrawal symptoms after clinical trials, and more than half were resolved within two weeks. Moreover, there was a “serious breakdown” at both the FDA and Eli Lilly in providing adequate warnings and instructions.

 

The analysis was conducted after the Institute for Safe Medicine Practices, after reviewing adverse events reported to in the first quarter of 2012 and found 48 case reports of drug withdrawal for Cymbalta. These included blackouts, suicidal thoughts, tremor, and nausea, and several cases involved hospitalization. This contrasted with an FDA safety review conducted in 2001 for the Cymbalta new drug application.

 

....

 

Meanwhile, Lilly studied withdrawal effects in nine early clinical trials for depression. ....

 

Lilly, subsequently, reported symptoms in 44 percent of patients who discontinuing Cymbalta after nine weeks or less, and 50 percent in longer trials. “About 10 percent of withdrawal symptoms in short-term trials were rated as severe and nearly 54 percent had not resolved after up to two weeks. What happened to these patients after two weeks is unknown. The outcomes of severe and persistent cases remain poorly studied,” ISMP writes.

 

What does the Cymbalta medication guide say? Not much: “Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.” Not surprisingly, ISMP called the patient guide is “materially deficient. It gives no hint of the persistence or severity of the symptoms known to occur.”

 

As ISMP notes, the guide does not address what the non-profit calls basic questions: What kinds of symptoms are most common? Should patients taper off the dose, and if so, how slowly? What should a patient do if depression or other symptoms recur? Is there a way to tell whether these are withdrawal symptoms or the previous illness returning? (read the prescribing information here).

 

ISMP writes that it was unable to identify patient info from the FDA or Lilly about discontinuation. When Lilly was asked, the drugmaker replied by writing that .... “If a consumer requests additional information we inform them to consult their physician because they know the patient’s complete medical history.” We have asked Lilly for comment and will update you accordingly.

 

While the prescribing information lists a dozen issues for doctors to discuss with patients before starting treatment, ISMP notes that withdrawal problems are not on the list, although Lilly did provide two summaries of responses the drugmaker offers doctors with questions – one focused on what was known about discontinuation risks and the other focused on tapering dosages, ISMP writes.

 

Was the summary sufficient? ISMP gives a mixed review. The summary cited two published studies and excerpted pertinent detail, including prescribing information and a synopsis of company studies, including the 44 percent incidence of symptoms in the depression trials and results of other studies. But there was little to no information on discontinuation or tapering dosages.

 

A one-page summary on discontinuation “merely reports that in only a few trials were the doses tapered, and then only over two weeks. Lilly’s response may well be limited because neither the company nor the government has adequately studied how to discontinue patients comfortably and safely, or how to manage those patients in which withdrawal symptoms are severe or persistent.

 

The upshot: ISMP concludes by writing that “....a major gap exists in our scientific understanding of the incidence and management of withdrawal syndrome cases that are severe and persistent.”

 

[uPDATE: The following day, a Lilly spokeswoman writes us this: The ISMP report "contains factual errors regarding the current FDA-approved product label and current FDA-approved Medication Guide for Cymbalta. These errors include, but are not limited to: The report claims that the “duloxetine Medication Guide does not contain clear warnings and useful instructions regarding potential discontinuation symptoms.” However, the current FDA-approved Medication Guide does outline potential serious symptoms.

 

The report also states that the 'duloxetine prescribing information only lists 12 topics for physicians to discuss with patients before starting treatment with duloxetine and that withdrawal problems are not on the list.' In fact, Section 17 of the current USPI (Patient Counseling) includes information on 20 topics for physicians to discuss with patients before starting treatment, and specifically includes information on discontinuation of treatment.

 

Finally, the report notes that the USPI only includes a single sentence to describe a tapering regimen. Yet this is discussed in detail in several areas of the current USPI. Lilly also believes the report incorrectly uses the word 'withdrawal' in place of 'discontinuation.' 'Withdrawal' corresponds to a different physiological and psychological mechanism, which denotes tolerance and/or abuse potential, and should be reserved for drugs with abuse and dependency liability. Antidepressants do not fall under this category. Lilly uses the word 'discontinuation' to describe symptoms of stopping medication throughout the current FDA-approved USPI and Medication Guide.]

 

[ANOTHER UPDATE: This comes from ISMP's Tom Moore in response to the reply from Lilly: "The issue has nothing to do with alleged 'factual errors' in the QuarterWatch October report. On the eve of publication, the FDA approved new prescribing information for physicians and a revised Medication Guide for patients. QuarterWatch accurately described the many shortcomings with the existing FDA approved materials. These findings also apply the 'Important Safety Information' now posted on the Lilly’s Cymbalta web site (www.cymbalta.com).

 

"The new duloxetine materials differ from the earlier 2012 version but continue to display a serious lapse in information about duloxetine withdrawal effects. The Medication Guide now contains a list of symptoms that occur when patients stop taking duloxetine but the language is vague. (Without taper information what does 'stopping too quickly' mean?) The discontinuation issue is now even less prominent, included among 16 warnings or precautions, 20 counseling topics, and 12 important safety items for patients.

 

"These new materials reaffirm our concern about a serious lapse in Lilly’s information for both physicians and patients. It does not adequately describe the frequency, severity and persistence of side effects among patients trying to stop duloxetine, or provide a useful taper regimen.

 

"Lilly also complained about the use of the term 'drug withdrawal syndrome' to describe the serious symptoms reported by duloxetine patients trying to stop the drug. The term was selected because it was included on 33 of 48, or 69 percent, of withdrawal side effects cases reported by Lilly or directly to the FDA in the first quarter of 2012. In 2011, drug withdrawal syndrome was the second most frequently reported side effect of duloxetine including both patients taking the drug or trying to stop.]

Edited by Altostrata
added updates

This is not medical advice. Discuss any decisions about your medical care with a knowledgeable medical practitioner.

"It has become appallingly obvious that our technology has surpassed our humanity." -- Albert Einstein

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Excellent comment, as always, Alto.

Pristiq tapered over 8 months ending Spring 2011 after 18 years of polydrugging that began w/Zoloft for fatigue/general malaise (not mood). CURRENT: 1mg Klonopin qhs (SSRI bruxism), 75mg trazodone qhs, various hormonesLitigation for 11 years for Work-related injury, settled 2004. Involuntary medical retirement in 2001 (age 39). 2012 - brain MRI showing diffuse, chronic cerebrovascular damage/demyelination possibly vasculitis/cerebritis. Dx w/autoimmune polyendocrine failure.<p>2013 - Dx w/CNS Sjogren's Lupus (FANA antibodies first appeared in 1997 but missed by doc).

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  • 4 years later...

"a major gap exists in our scientific understanding of the incidence and management of withdrawal syndrome cases that are severe and persistent."

 

Finally! 

WARNING THIS WILL BE LONG
Had a car accident in 85
Codeine was the pain med when I was release from hosp continuous use till 89
Given PROZAC by a specialist to help with nerve pain in my leg 89-90 not sure which year
Was not told a thing about it being a psych med thought it was a pain killer no info about psych side effects I went nuts had hallucinations. As I had a head injury and was diagnosed with a concussion in 85 I was sent to a head injury clinic in 1990 five years after the accident. I don't think they knew I had been on prozac I did not think it a big deal and never did finish the bottle of pills. I had tests of course lots of them. Was put into a pain clinic and given amitriptyline which stopped the withdrawal but had many side effects. But I could sleep something I had not done in a very long time the pain lessened. My mother got cancer in 94 they switched my meds to Zoloft to help deal with this pressure as I was her main care giver she died in 96. I stopped zoloft in 96 had withdrawal was put on paxil went nutty quit it ct put on resperidol quit it ct had withdrawal was put on Effexor... 2years later celexa was added 20mg then increased to 40mg huge personality change went wild. Did too fast taper off Celexa 05 as I felt unwell for a long time prior... quit Effexor 150mg ct 07 found ****** 8 months into withdrawal learned some things was banned from there in 08 have kept learning since. there is really not enough room here to put my history but I have a lot of opinions about a lot of things especially any of the drugs mentioned above.
One thing I would like to add here is this tidbit ALL OPIATES INCREASE SEROTONIN it is not a huge jump to being in chronic pain to being put on an ssri/snri and opiates will affect your antidepressants and your thinking.

As I do not update much I will put my quit date Nov. 17 2007 I quit Effexor cold turkey. 

http://survivingantidepressants.org/index.php?/topic/1096-introducing-myself-btdt/

There is a crack in everything ..That's how the light gets in :)

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  • 5 weeks later...

Thanks for posting this.

'finally' seconded.

Yet i keep saying finally and nothing changes.

 

What happened to these patients after two weeks is unknown.

The medical profession should be deeply ashamed about this ignorance.

 

 

 

 

Thought for the day: Lets stand up, and let’s speak out , together. G Olsen

We have until the 14th. Feb 2018. 

URGENT REQUEST Please consider submitting  for the petition on Prescribed Drug Dependence and Withdrawal currently awaiting its third consideration at the Scottish Parliament. You don't even have to be from Scotland. By clicking on the link below you can read some of the previous submissions but be warned many of them are quite harrowing.

http://www.parliament.scot/GettingInvolved/Petitions/PE01651   

Please tell them about your problems taking and withdrawing from antidepressants and/or benzos.

Send by email to petitions@parliament.scot and quote PE01651 in the subject heading. Keep to a maximum of 3 sides of A4 and you can't name for legal reasons any doctor you have consulted. Tell them if you wish to remain anonymous. We need the numbers to help convince the committee members we are not isolated cases. You have until mid February. Thank you

Recovering paxil addict

None of the published articles shed light on what ssri's ... actually do or what their hazards might be. Healy 2013. 

This is so true, with anything you get on these drugs, dependance, tapering, withdrawal symptoms, side effects, just silent. And if there is something mentioned then their is a serious disconnect between what is said and reality! 

  "Every time I read of a multi-person shooting, I always presume that person had just started a SSRI or had just stopped."  Dr Mosher. Me too! 

Over two decades later, the number of antidepressant prescriptions a year is slightly more than the number of people in the Western world. Most (nine out of 10) prescriptions are for patients who faced difficulties on stopping, equating to about a tenth of the population. These patients are often advised to continue treatment because their difficulties indicate they need ongoing treatment, just as a person with diabetes needs insulin. Healy 2015

I believe the ssri era will soon stand as one of the most shameful in the history of medicine. Healy 2015

Let people help people ... in a natural, kind, non-addictive (and non-big pharma) way. J Broadley 2017

 

 

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  • Moderator
On 10/8/2012 at 5:39 PM, Altostrata said:

Lilly also complained about the use of the term 'drug withdrawal syndrome' to describe the serious symptoms reported by duloxetine patients trying to stop the drug. The term was selected because it was included on 33 of 48, or 69 percent, of withdrawal side effects cases reported by Lilly or directly to the FDA in the first quarter of 2012. In 2011, drug withdrawal syndrome was the second most frequently reported side effect of duloxetine including both patients taking the drug or trying to stop.]

 

 

On 10/8/2012 at 5:39 PM, Altostrata said:

Finally, the report notes that the USPI only includes a single sentence to describe a tapering regimen. Yet this is discussed in detail in several areas of the current USPI. Lilly also believes the report incorrectly uses the word 'withdrawal' in place of 'discontinuation.' 'Withdrawal' corresponds to a different physiological and psychological mechanism, which denotes tolerance and/or abuse potential, and should be reserved for drugs with abuse and dependency liability. Antidepressants do not fall under this category. Lilly uses the word 'discontinuation' to describe symptoms of stopping medication throughout the current FDA-approved USPI and Medication Guide.]

 

Urghh......I am feeling some withdrawal coming on?  There IS dependency liability.

 

Come on, come on, come on............when are they going to take some responsibility?  Pay attention?

 

Some have died.  I know one who did.  Suicide. 

 

Anyway.........glad this popped on up to the top again.

 

Grim.

 

mmt (Effexor survivor tonight)

2022 May- continuing with limited activity on site, just something I need to do right now

Started with psycho meds/psychiatric care circa 1988.  In retrospect, and on contemplation, situational overwhelm.

Rounding up to 30 years of medications(30 medication trials, poly-pharmacy maximum was 3 at one time).

5/28/2015-off Adderal salts 2.5mg. (I had been on that since hospital 10/2014)

12/2015---just holding, holding, holding, with trileptal/oxcarb at 75 mg. 1/2 tab at hs.  My last psycho med ever!  Tapered @ 10% every 4 weeks, sometimes 2 weeks to

2016 Dec 16 medication free!!

Longer signature post here, with current supplements.

Herb and alcohol free since 5/15/2016.  And.....I quit smoking 11/2021. Lapsed.  Redo of quit smoking 9/28/2022.  Can you say Hallelujah?(took me long enough)💜

None of my posts are intended as medical advice.  Please discuss any decisions about your medical care with a knowledgeable medical provider. manymoretodays

 

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