Global healthcare research firm BMJ has just announced that upon reanalysis of an antidepressant trial, it was found that the antidepressant paroxetine by GlaxoSmitKline (GSK) is, in fact, not safe or effective for adolescents when it comes to depression treatment. This conclusion is in stark contrast to findings from the original study published in 2001.
In 2001, SmithKline Beecham (which soon became known as GSK) funded a study in order to compare the effectiveness and safety of two antidepressant drugs when it comes to adolescents who have been diagnosed with major depression. This resulted in Study 329 working on an in-depth analysis of drugs paroxetine and imipramine with placebo.
The said study had then concluded that paroxetine was indeed “safe and effective” for treatment of adolescents. Moreover, this result was also published in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) in the same year.
The said study then came under heavy criticism the following year by the U.S. Food and Drug Administration (FDA). However, more than 2 million prescriptions for the said drug were said to have been written for both adolescents and children in the United States.
In 2007, the FDA had also proposed to makers of antidepressant medications to make updates in their black box warning when it came to “increased risks of suicidal thinking and behaviour” among young adults aged 18 to 24. This condition, known as suicidality, is found prevalent during the initial treatment stage or the first one to two months of undergoing antidepressant drug treatment. One of the drugs recommended to undertake such action was Paxil or paroxetine HCl. Furthermore,in 2012, GSK was fined $3 billion partly for promoting paroxetine fraudulently.
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The reanalysis was actually done as part of BMJ’s Restoring Invisible and Abandone Trials (RIAT) initiative. This study involving paroxetine was actually the first trial reanalyzed.