Tuesday, September 12, 2006

Yet More New Research on Antidepressants and Suicide

Uh-oh. David Healy is at it again.

Not good news for SmithKlineBeecham, the manufacturer of paroxetine (Paxil).

Healy and colleagues utilized data from a few sources in their latest article in PLoS Medicine:

1. The data submitted by GlaxoSmithKline on paroxetine for review by the Committee on Safety of Medicines Expert Working Group

2. Data from United Kingdom Drug Safety Research Unit (DSRU) prescription-event monitoring studies on paroxetine and fluoxetine

3. Legal cases in which the authors have given evidence. This is admittedly a little shakier, though still of interest.

4. E-mails from 1,374 patients in response to a BBC programme on paroxetine broadcast in 2002.

What did they find? Let's focus on data type 1 for this post...

*In clinical trial data provided by the manufacturer, participants taking Paxil were significantly more likely to show hostility (Odds Ratio = 2.10).

*The following data comes from trials NOT included in the previous bullet point: "In data from sertraline paediatric trials submitted by Pfizer, aggression was the joint commonest cause for discontinuation from the two sertraline placebo-controlled trials in depressed children. In these trials, eight of 189 patients randomised to sertraline discontinued for aggression, agitation, or hyperkinesis (a coding term for akathisia), compared with no dropouts for these reasons in 184 patients on placebo (95% CI, 1.72–infinity). When discontinuations for any manifestation of treatment induced activation (suicidal ideation or attempts, aggression, agitation, hyperkinesis, or aggravated depression) were considered, there were 15 discontinuations on sertraline compared with two on placebo, a relative risk of 7.3 (95% CI, 1.70–31.5; p = 0.0015) (p. e373)."

*Very limited data on healthy volunteers suggests increased hostility among people taking paroxetine.

*The link between akathisia (which is induced on occasion by antidepressants) and aggression as well as suicide is explored

Summary: There is certainly much more in the article than I can describe now (like data from the other three sources). It admittedly falls well short of a smoking gun, but it nicely summarizes research on the topic with a close eye on paroxetine. The evidence continues to slowly trickle down and it has often been inconsistent, but there is certainly enough data to suggest that at the very least we should insist on full disclosure of data from clinical trials, warn about possible aggression/suicidality side effects, and monitor patients for aggression/suicidality quite closely. Oh, and we should use psychotherapy first -- better results in the long term with many fewer side effects.

The full text of the article is here.


Fid said...

GSK have known about the perils of Seroxat (Paxil) fr nigh on 15 years yet sat on the information.



Check out my blog for the facts

CL Psych said...

I very briefly checked out your site and hope to have more time to examine it more closely at some point. With any luck, I'd like to post a little more info on SSRI's, including Paxil/Seroxat in the next few days. Thanks for the comment.