December 05, 2007

Psych Doc Loves Off-Label Uses

The anonymous psych doc who authors The Corpus Callosum over at Science Blogs--home of many a smart-seeming, but dumb-thinking neuro blogger--is all a-twitter over a new anti-depressant, Agomelatine. He can't wait for it to be approved so he can try some off-label for anxiety:

"Once the drug has been on the market for a while, say about a year, it might be worth trying it for off-label things, such as anxiety. I suspect it may find a role in treatment of insomnia even in the absence of a mood disorder."

Perhaps, he ought to try it on himself first, because we all know how successful off-label prescribing is for psych meds.

And it looks like the anonymous psych doc missed something:

"On 27 July 2006 the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMEA) recommended a refusal of the marketing authorisation of Valdoxan/Thymanax. The major concern was that efficacy had not been sufficiently shown."

Apparently, Novartis plans to file for approval next year. Stay tuned.

Posted by Philip Dawdy at December 5, 2007 08:53 AM
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The paper showing efficacy was published after July 27, 2006, which might account for why it was rejected at that date. The whole story may not be out yet, but the information that is available suggests that, at the very least, it doesn't have the discontinuation syndrome and sexual side effects of SSRIs. The one downside is that, as the anonymous psych doc points out, we don't yet know if it will precipitate a polarity switch.

I don't really understand your negativity toward this drug. It will provide an alternative to SSRIs, and it may turn out to be much safer. Additional pre-market studies might be able tell us more about possible side effects, but from what's available, they seem much milder than those of SSRIs.

Posted by: Simon at December 5, 2007 10:33 AM

From the psych at The Corpus Callosum that you link to:

The reason to be cautious, is that it is common for drugs to be released with great fanfare, often with unrealistic expectations about lack of particular adverse effects. The thing is, you never really know about the incidence of adverse effects until the drug has been given to tens of thousands, if not millions, of persons.

Which is what I was thinking about. I wouldn't dare get excited about a drug that is new to market and I think it takes a hell of a lot longer than a year to know if they are safe. It's been more than two decades and there are still asshats that claim SSRI's and atypicals are safe---certainly in contrast to the GREAT risk of depression and psychosis (or anxiety, or irritability---whatever off-label indication you've been given any given drug for)

No, I won't trust big pharma to come out with ANY drug I'm willing to take. I'm waiting for studies done on safe non-toxic substances that I'm already treating myself with just so I can prove that they actually working and spread the good news. Mother nature as pharmacy---all we can do now is experiment based on lots of anecdotes. We've got to move money around and start studying safe natural medicine so that it gains the credibility it deserves.

Posted by: Gianna at December 5, 2007 11:34 AM

Just because it's natural doesn't mean it's safe. Ephedra, belladona, and reserpine, a component of Indian snakeroot, are all natural products with the same kinds of negative side effects as many psych meds. Natural remedies have existed for thousands of years, but, ultimately, clinical studies will tell us no more about their safety than they tell us about the safety of novel synthetic antidepressants and antipsychotics.

Posted by: Simon at December 5, 2007 03:39 PM

I certainly didn't suggest all things natural are safe, now did I?

Posted by: Gianna at December 5, 2007 04:52 PM

that message got away from me...
In any case, no not all things natural are safe, but there are far more reports of pharmaceuticals being unsafe than any of the nutrients I choose to use. One must be educated and careful in any case. I can say I suffer no side effects from any of the nutrients I use. Nothing adverse. That's not to say I haven't had an adverse reaction to something natural, I have and I discontinued it immediately, something my psychiatrist never suggested I do when I became grossly impaired on psych meds.

Posted by: Gianna at December 5, 2007 04:59 PM

When I read this entry, all I saw were the words "off-label" and "anxiety"; due to a PCP/General Practioner doc rx me Prozac and Zyprexa in 2003 for "anxiety".

This is a dangerous thought process for professionals who write prescriptions for a living.

Posted by: Stephany at December 5, 2007 07:25 PM
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