FDA 2009 Report

Cymbalta (Duloxetine)

Discontinuation Syndrome

Issues of Scope, Severity,

Duration & Management

June 9, 2009

Cymbalta Discontinuation Syndrome

• Much anecdotal evidence has accumulated documenting the

injury, distress and life management impacts caused by

discontinuation of Cymbalta

– 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

– Physical and psychological disturbances adversely affect job function

and family/social relationships

• Employment risk

• Negative impacts on care of family members

Claims

1) Cymbalta discontinuation syndrome is more severe and much

more widespread than acknowledged by Eli-Lilly

2) Lilly sales representatives and marketing materials do not

adequately inform physicians about the likelihood and severity of discontinuation syndrome

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

Many websites document Cymbalta withdrawal trauma

anecdotally (1,000’s of Entries)

• What Winners Do:

http://www.whatwinnersdo.com/severe-cymbalta-withdrawal-symptoms/

• Cymbaltawithdrawal.com

http://www.cymbaltawithdrawal.com/

• Depressionforums:

http://www.depressionforums.org/forums/Cymbalta-Withdrawal-It-s-Pretty-

t13148.html

• Point of Return:

http://www.labelmesane.com/cymbalta_withdrawal.html

– Third party withdrawal assistance

• Why should a consumer need to pay to discontinue?

• Depression Hurts, Cymbalta Hurts More!

http://www.youtube.com/watch?v=yeq4gSfMXdo

• Youtube video

• Concise (2:30) description of the trauma and its effects

• Cafepharma:

http://www.cafepharma.com/boards/showthread.php?t=207484

– (Not Lily sponsored) drug rep page – The reps are aware of the issue

• If the reps know, why don’t the physicians know

Typical Cymbalta Withdrawal Anecdotes*

“May 15th, 2009 at 4:24 pm Day 38. My Doctor didn’t know or she didn’t tell me that going

off Cymbalta would be a serious life challenge. Perhaps there are patients that do not have

the withdrawal side effects (like consistent suicidal thoughts, the inability to control

incredible irritability that quickly turns to rage…over nothing…paranoia, dizziness, confusion,

brain zaps, dramatic change in eating patterns, helplessness, hopelessness, dysphoria…) I

guess there must be people out there that move easily back to a life without Cymbalta. But I

sort of can’t imagine it…”

“May 16th, 2009 at 11:47 am “Hey everyon! Wow, I thought I was going crazy. I went clean

and sober and to deal with the depression that comes with it, I was put on Cymbalta. I do

sixty mg. a day. I had a mishap with my insurance and they wouldn’t allow me to buy it

unless I paid an outrageous price of 120.00 for thirty pills. Well I opted to wait it out. 10 days.

Well I nearly went to jail. I was so confused I fought everyone in my family for no reason. I

even suffered broken ribs. It was far better than them “brain-zaps” They will certainly kill me.

I can’t seem to move my eyes without the utterly horrible feelings that come with such a

simple jesture. I tried explaining it to my family. (warning) Then I went to the doctor tried to

explain my symptoms and he thought I was crazy.

*Verbatim abstracts from the What Winners Do web site

 

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