A recent re-analysis of a 2001 study revealed that Paxil, or paroxetine, is unsafe and ineffective for teens.
According to The Guardian, the influential Study 329 examined the effects of GlaxoSmithKline's antidepressant paroxetine on teens under 18 and has declared that the drug was safe for children and adolescents.
However, it has been discovered to be a flawed study, failing to report actual facts about a side effect—the actual number of users who thought of suicide while on it. As such, drug regulators in 2003 announced that paroxetine, known as Aropax, Paxil, or Seroxat, was not to be prescribed to adolescents.
In the re-analysis published in the British Medical Journal (BMJ), researchers said that the beneficial effects of the drug on teens were actually far less than what the original study, whose authors were led by Martin Keller of Brown University, had suggested. Basing on the original study data that they acquired, the researchers said that this 2001 study has to be retracted.
"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," said Professor Jon Jureidini, of the University of Adelaide's Critical and Ethical Mental Research Group (CEMH),as per Medical Daily. He and his colleagues were responsible for the re-analysis.
The previous research evaluated the effects of the drug on young people. Two-hundred seventy-four children and adolescents diagnosed with major depression were either given the drug or a placebo. Wrong conclusions have been made, saying that paroxetine had helped those who had taken it, in comparison to those taking a placebo.
The earlier study also reported that five paroxetine takers in every one placebo taker had suicidal or self-harming behavior, but factual information showed 11 taking the drug and one taking a placebo had suicidal or self-harming behavior.
The US Food and Drug Administration in 2002 said that the trial should be considered a failure because the depressed youth taking paroxetine didn't do better compared to those taking the placebo. In the same year, however, due to the drug being promoted as having "remarkable efficacy and safety" based on the failed test, more than two million prescriptions of the drug were written for depressed US youth.
GSK was fined $3 billion in 2012 for the fraudulent promotion of the drug.
This is the first re-analysis of a drug study under Restoring Invisible and Abandoned Trials. The publication of the re-analyzed data "sets the record straight" and "shows the extent to which drug regulation is failing us," according to BMJ editor in chief Dr. Fiona Godlee.
