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Re: Duloxetine: antidepressant drug trial turns deadly

Posted by Rayray on April 11, 2004, at 11:54:28

In reply to Re: Duloxetine: antidepressant drug trial turns deadly, posted by snapper on April 3, 2004, at 0:08:40

> > My god, the article says the study used doses six times that considered therapeutic for depression! What kind of study is that? Why in the world would Lilly test duloxetine using what would generally be regarded as an overdose? That's totally bizarre.
>
> I could be wrong , but I believe that when they do clinical trials, and especially with "normal" healthy subjects; they do this because they are in a very clinical controlled atmosphere or supposedly- the thing being that if some one in the "actual depressed population" would ingest that amount, they need to know that they would recover 'with out' (what they say in med. terms ) without 'sequele' also in studies -I believe that should something serious occur such as unexpected and severe adverse side effects or reactions, they would be able to provide prompt and appropriate medical intervention...Unfortantely they most likely did not see the poor girl as a serious risk for a potential suicide possibility. Sadly they missed something- that sad severe adverse effect in this case turned out to be death!! just my thoughts!!
>
> Snapper
>

I understand the need for drug companies to test drugs on healthy volunteers and the need to establish safety thresholds. What I haven't seen discussed regarding the recent suicide victim in the duloxetine trial is the role played by abrupt cessation of these meds.

According to the Miami Herald (3/22/04), "Johnson had taken duloxetine for 20 days during the study, which included doses as high as five times normal, but she had been on a placebo for four days when she died, according to Lilly."

Posters to these highly valuable boards write frequently of the horror shows attending sudden stoppage of meds -- particularly Effexor from what I see. I wish drug companies would pay more attention to this.

It would be a shame if what may be a significant breakthrough like duloxetine is delayed or derailed by media sensationalism or inadequate analysis.

Personally, I feel like I am "pooping out" on Zoloft 150mg + 300mg Wellbutin per day and am not sure where to go next. I was hoping duloxetine would be the answer.

Does anybody know anything about the current release status of Cymbalta or does this summer still look like a bet?

Rayray



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URL: http://www.dr-bob.org/babble/20040407/msgs/335184.html