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Original Fda Approval Of Cymbalta


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#1 ConnieStar

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Posted 22 September 2017 - 12:29 PM

This may not be news to older members of this forum, but I research Duloxetine in two medical journals I have subscriptions to.

The take away that struck me is from The Medical Letter, from 200 Issue 1193

 

CONCLUSION —
In the manufacturer’s clinical trials,
duloxetine
(Cymbalta)
, a new SNRI, was more effective
than placebo for treatment of depression, but in some
trials higher-than-approved doses of the drug were used
and the SSRI comparator was ineffective, raising ques-
tions about the validity of the results. Whether duloxetine
offers any advantage over venlafaxine
(Effexor)
or an
SSRI such as fluoxetine (
Prozac
, and others) remains to
be established. The manufacturer’s claim that duloxetine
is
the
antidepressant for painful physical symptoms

associated with depression is unsupported

 

Unsupported? Trials conducted by the manufacturer? These are red flags.

 


#2 fishinghat

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Posted 22 September 2017 - 05:03 PM

I have tons of documents like that from the court hearings over lawsuits. Eli Lilley said that there was no significant withdrawal in their original submission to the FDA and of course it was obvious very rapidly that that was wrong. In the first lawsuit a whistleblower came forward with documentation that Eli Lilley WAS aware and that even 2 suicides had occurred during testing. I don't remember how many millions they were fined. Once the dust settled on numerous class action lawsuits the courts ruled about warning patients about 'discontinuation syndrome' in a black box warning in the drug insert with the med. The court did N OT require the FDA to issue warnings to physicians and many still are unaware of all the changes that have been made to the Cymbalta  drug insert.

 

Sad Sad. I have quite a library stored up with medical journal articles on Cymbalta if you are curious. I would be glad to share. Oh by the way. Are you familiar with pssd?  A big issue with Cymbalta right know. Lets hope it doesn't hit you or any of your patients.


#3 thismoment

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Posted 22 September 2017 - 11:01 PM

I think it would be fair to say that PSSD (Post SSRI Sexual Dysfunction) is a range of symptoms, rather than all-or-nothing situation.

 

One of the insidious effects of these neurotoxins is this: they alter a great number of functions in a variety of ways-- some are subtly changed, some profoundly, and some things seem to improve. As you've all noted, it's a bit of a crapshoot. 

 

Therefore, I would like to include my take on PSSD-- please consider this: PSASF: Post SSRI Altered Sexual Function. For me, sex just became something different, something not quite the same; it was broadly unsatisfactory.

 

I can see how the altered event could lead to simply saying, "No thanks", and at that point one would rightfully add on the D, for Dysfunction. 


#4 fishinghat

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Posted 23 September 2017 - 07:38 AM

Agreed, Varied in its effects.



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