Drug thought safe for teenagers linked to suicidal and self-harming behaviours.
A common antidepressant thought safe for adolescents is actually ineffective, new research finds.
Worse, it has been linked to serious side-effects.
The drug is called paroxetine, which is marketed as Paxil, Seroxat and Aropax.
The conclusions come from a re-evaluation of a study — known as ‘Study 329’ — carried out in 2001 .
Study 329, which was funded by the pharmaceutical company GlaxoSmithKline, originally claimed paroxetine was effective and safe.
Not only were these conclusions wrong, the new analysis argues, but the drug has worrying side-effects.
Professor Jon Jureidini, who led the research, said:
“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.
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.
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.”
Professor Jureidini thinks pharmaceutical companies should make their data available for reanalysis.
“Our reanalysis of Study 329 came to very different conclusions to those in the original paper.
We also learnt a lot about incorrect reporting and the considerable fall out that can be associated with distorted data.
Regulatory research authorities should mandate that all data and protocols are accessible.
Although concerns about patient confidentiality and ‘commercial in confidence’ issues are important, the reanalysis of Study 329 illustrates the necessity of making primary trial data available to increase the rigour of evidence-based research.”
The research was published in the British Medical Journal (Noury et al., 2015).
Image credit: JLA