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Eli Lilly faces first U.S. Trials over Cymbalta Withdrawal


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REUTERS: http://www.reuters.com/article/2015/08/03/us-eli-lilly-cymbalta-trial-idUSKCN0Q825220150803

 

 
Health Mon Aug 3, 2015 4:16pm EDT
Related: HEALTH
Eli Lilly faces first U.S. trials over Cymbalta withdrawal
NEW YORK BY JESSICA DYE
 
 

Eli Lilly & Co on Tuesday will confront the first U.S. trial over allegations it failed to warn users of its popular antidepressant Cymbalta that they could suffer severe withdrawal symptoms, including suicidal thoughts and electric shock-like sensations.

 

Plaintiff Claudia Herrera is one of about 250 people who have sued Lilly over Cymbalta, and the company faces three more trials later this month involving similar claims, according to a lawyer for Herrera, R. Brent Wisner.

These early trials will be a critical test for litigation over the drug, which had $3.9 billion in sales in 2013 before losing patent protection at the end of that year and brought in $561 million in the first half of 2015.

Cymbalta, part of a class of antidepressants known as serotonin and norepinephrine reuptake inhibitors, was approved by the U.S. Food and Drug Administration in 2004 to treat major depressive disorder. Later, approval was expanded to include generalized anxiety disorder and fibromyalgia.

 

Its label warns that 1 percent or more of users who discontinue Cymbalta may experience symptoms like nausea, irritability and insomnia, and that other symptoms such as sensory disturbances and seizures had been reported.

But plaintiffs suing Lilly allege that withdrawal symptoms are far more common, pointing to a 2005 analysis from the Journal of Affective Disorders that found more than 44 percent of patients reported at least one discontinuation symptom.

A Lilly spokeswoman declined to comment specifically on Herrera’s allegations and said that the company would vigorously defend that case and others.

 

According to Herrera’s lawsuit in California federal court, she started taking Cymbalta in 2006 for anxiety. When her doctor instructed her in 2012 to ease off gradually, she said that she suffered electric-like “zaps,” anxiety, spasms and suicidal ideation, among other symptoms.

Herrera accused Lilly of downplaying its warnings to make the drug more marketable. Lilly said in court filings that it gave sufficient warnings, and that her doctor was aware of the potential risks.

 

A similar case is set for trial in California starting Aug. 11.

Other Cymbalta lawsuits have been less successful. A New York judge last year granted Lilly a win in a case similar to Herrera's and twice, a federal judge in California has denied plaintiffs’ motions for class certification on consumer-protection claims related to Cymbalta marketing.

 

The California trials, and two more scheduled to start in Virginia in late August, will be the first opportunities for juries to evaluate the underlying claims.

 

“The success or failure of these cases will give us a good sense of how they are playing to these juries,” Wisner said. “Even if we lose, we have every intention of moving forward with the litigation.”

1987-1997 pertofran , prothiaden , Prozac 1997-2002 Zoloft 2002-2004 effexor 2004-2010 Lexapro 40mg

2010-2012Cymbalta 120mg

Sept. 2012 -decreased 90mg in 6months. Care taken over by Dr Lucire in March 2013 , decreased last 30mg at 2mg per week over 3 months. July 21 , 2013- last dose of Cymbalta

Protracted withdrawal syndrome kicked in badly Jan.2014 Unrelenting akathisia until May 2014. Voluntary hosp. admission. Cocktail of Seroquel, Ativan and mirtazapine and I was well enough to go home after 14 days. Stopped all hosp. meds in next few months.

July 2014 felt v.depressed - couldn't stop crying. Started pristiq 50mg. Felt improvement within days and continued to improve, so stayed on 50mg for 8 months.

Began taper 28 Feb. 2015. Pristiq 50mg down to 45mg. Had one month of w/d symptoms. Started CES therapy in March. No w/d symptoms down to 30mg.

October 2015 , taking 25mg Pristiq. Capsules compounded with slow-release additive.

March 2016 , 21mg

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Excellent find Fresh. Thanks for posting . This is huge stuff.

 

Hopefully the start of a recognition of wdl. Apparently in the next 12 months litigants will take GSK to court in the UK in respect of paxil for same reasons.

'Follower'

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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Last week went badly. Don't know about today. Two more in August. This is about the exspurt witness who's a sadist or a liar. Both.

 

:angry: "Douglas Jacobs" a psychiatrist. Full of SShRIt <_<

 

http://fiddaman.blogspot.co.uk/2015/08/lillys-cymbalta-expert.html

 

Begins like this:

 

Late last week a jury ruled that Eli Lilly and Co. isn’t liable for withdrawal symptoms including brain zaps experienced by a woman, Claudia Herrera, after she quit the antidepressant Cymbalta.

The crux of the argument, it seems, was that Lilly faced claims of not disclosing, on the warning label for Cymbalta, that 44% of users, in its own studies, suffered discontinuation side effects. Instead, plaintiff lawyers argued, Cymbalta’s label initially disclosed that 2% or more experienced certain side effects.

Lilly's legal team hit back suggesting that  the 44% figure wasn’t relevant to prescribers because, in the same studies, 22% of subjects discontinuing a placebo also reported side effects. The label discloses the Cymbalta withdrawal side effects that occurred significantly more frequently than those of people who took a sugar pill.

Obviously, both sides would need more evidence to provide to a jury. Lilly's expert. it appears, may have tipped the balance.

Douglas Jacobs, a psychiatrist, told jurors there’s no evidence in the medical literature of withdrawal symptoms lasting for months. Herrera’s symptoms might have been a manifestation of her underlying depression and anxiety disorders,

It's classic pharma defence, blame the "illness" and not the drug. So exactly who is Lilly's expert, Douglas Jacobs? Well, he and Eli Lilly go way back.

2009: Cancer hospital said I had adjustment disorder because I thought they were doing it wrong. Their headshrinker prescribed Effexor, and my life set on a new course. I didn't know what was ahead, like a passenger on Disneyland's Matterhorn, smiling and waving as it climbs...clink, clink, clink.

2010: Post surgical accidental Effexor discontinuation by nurses, masked by intravenous Dilaudid. (The car is balanced at the top of the track.) I get home, pop a Vicodin, and ...

Whooosh...down, down, down, down, down...goes the trajectory of my life, up goes my mood and tendency to think everything is a good idea.
2012: After the bipolar jig was up, now a walking bag of unrelated symptoms, I went crazy on Daytrana (the Ritalin skin patch by Noven), because ADHD was a perfect fit for a bag of unrelated symptoms. I was prescribed Effexor for the nervousness of it, and things got neurological. An EEG showed enough activity to warrant an epilepsy diagnosis rather than non-epileptic ("psychogenic") seizures.

:o 2013-2014: Quit everything and got worse. I probably went through DAWS: dopamine agonist withdrawal syndrome. I drank to not feel, but I felt a lot: dread, fear, regret, grief: an utter sense of total loss of everything worth breathing about, for almost two years.

I was not suicidal but I wanted to be dead, at least dead to the experience of my own brain and body.

2015: I  began to recover after adding virgin coconut oil and organic grass-fed fed butter to a cup of instant coffee in the morning.

I did it hoping for mental acuity and better memory. After ten days of that, I was much better, mood-wise. Approximately neutral.

And, I experienced drowsiness. I could sleep. Not exactly happy, I did 30 days on Wellbutrin, because it had done me no harm in the past. 

I don't have the DAWS mood or state of mind. It never feel like doing anything if it means standing up.

In fact, I don't especially like moving. I'm a brain with a beanbag body.   :unsure:

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Just makes me sick.

 

Why dont they get a plaintiff to testify who never had psychological distress prior to the drug say, and was prescribed for off label use for goodness sake.

Then that arguement is silenced for good.

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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There will be more in other states.  

Let's hope other defense lawyers are able to identify some evidence in the medical literature of protracted withdrawal.

1987-1997 pertofran , prothiaden , Prozac 1997-2002 Zoloft 2002-2004 effexor 2004-2010 Lexapro 40mg

2010-2012Cymbalta 120mg

Sept. 2012 -decreased 90mg in 6months. Care taken over by Dr Lucire in March 2013 , decreased last 30mg at 2mg per week over 3 months. July 21 , 2013- last dose of Cymbalta

Protracted withdrawal syndrome kicked in badly Jan.2014 Unrelenting akathisia until May 2014. Voluntary hosp. admission. Cocktail of Seroquel, Ativan and mirtazapine and I was well enough to go home after 14 days. Stopped all hosp. meds in next few months.

July 2014 felt v.depressed - couldn't stop crying. Started pristiq 50mg. Felt improvement within days and continued to improve, so stayed on 50mg for 8 months.

Began taper 28 Feb. 2015. Pristiq 50mg down to 45mg. Had one month of w/d symptoms. Started CES therapy in March. No w/d symptoms down to 30mg.

October 2015 , taking 25mg Pristiq. Capsules compounded with slow-release additive.

March 2016 , 21mg

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