Antidepressant was misrepresented as safe for adolescents

http://www.eurekalert.org/pub_releases/2015-09/uoa-awm091415.php

Public Release: 16-Sep-2015
Antidepressant was misrepresented as safe for adolescents
University of Adelaide

A University of Adelaide led study has found that a psychiatric drug claimed to be a safe and effective treatment for depression in adolescents is actually ineffective and associated with serious side effects.

Professor Jon Jureidini, from the University of Adelaide's newly created Critical and Ethical Mental Health Research Group (CEMH) at the Robinson Research Institute, led a team of international researchers who re-examined Study 329, a randomised controlled trial which evaluated the efficacy and safety of paroxetine (Aropax, Paxil, Seroxat) compared with a placebo for adolescents diagnosed with major depression.

Study 329, which was funded by SmithKline Beecham (now GlaxoSmithKline), was reported in 2001 as having found that paroxetine was effective and safe for depression in adolescents. However, Professor Jureidini's reanalysis showed no advantages associated with taking paroxetine and demonstrated worrying adverse effects.

"Although concerns had already been raised about Study 329, and the way it was reported, the data was not previously made available so researchers and clinicians weren't able to identify all of the errors in the published report," says Professor Jureidini.

"It wasn't until the data was made available for re-examination that it became apparent that paroxetine was linked to serious adverse reactions, with 11 of the patients taking paroxetine engaging in suicidal or self-harming behaviours compared to only one person in the group of patients who took the placebo," he says. "Our study also revealed that paroxetine was no more effective at relieving the symptoms of depression than a placebo."

"This is highly concerning because prescribing this drug may have put young patients at unnecessary risk from a treatment that was supposed to help them," he says.

•••••