Antidepressant, OCD drug Paxil not safe or effective for teens, study reveals

The drug Paxil by the GlaxoSmithKline (GSK) Company has been found to be not safe for teens with depression.

A previous study on antidepressant Paxil (paroxetine) has been disproven by a new analysis published in the journal BMJ. According to Time, the previous study published in the Journal of the American Academy of Child and Adolescent Psychiatry found Paxil to be "generally well tolerated and effective for major depression in adolescents." However, reports of suicidal ideations among adolescents seem to say otherwise and that is why the US Food and Drug Administration (FDA) investigated the effectiveness of Paxil on teenagers. It was then reported that the antidepressant was not advised for depressed teenagers.

The reanalysis was conducted by the Restoring Invisible and Abandoned Trials (RIAT) team led by Professor Jon Jureidini of University of Adelaide. They looked into the data on the trials of the drug Paxil versus imipramine with placebo on depressed teens. According to a report in Eureka Alert, Jureidini and colleagues found that there was no significant difference among Paxil, imipramine or placebo in treating depression in teens.

"The original study says paroxetine is safe and effective for the treatment of depressed adolescents," said Dr. John Nardo, co-author of the new analysis, from the Emory University Psychoanalytic Institute, said via HealthDay. "Ours says paroxetine is neither safe nor effective in the treatment of adolescents. And I don't know of any example where two studies in the literature with the same data ever reached opposite conclusions."

Paxil drugmaker, GlaxoSmithKline, responded to the study:

"Importantly, the findings from this team's analysis appear to be in line with the longstanding view that there is an increased risk of suicidality in paediatric and adolescent patients given antidepressants like paroxetine," GSK stated, according to the report by The Guardian. "This is widely known and clear warnings have been in place on the product label for more than a decade. As such we don't believe this reanalysis affects patient safety."

GSK was fined with $3 billion dollars in 2012 for promoting paroxetine without reporting its drug safety information to the FDA, Time reports.

According to Brian Nosek of the University of Virginia, the new analysis by RIAT was "alarming" but a "good thing."

"It signals that the community is waking up, checking its work and doing what science is supposed to do—self-correct," said Nosek, a professor of psychology who is not involved in the study, in a report by the New York Times.