A rare re-analysis of clinical trial results has found that the antidepressant paroxetine--commonly known as Paxil--is not effective and may even be unsafe when used by teenagers.
Researchers at the University of Adelaide in Australia, using previously confidential trial documents, took another look at previous research to compare paroxetine and the higher-dosage imipramine with a placebo for effectiveness and safety in treating major depression among adolescents.
The original study from Brown University looked at 275 adolescents from 12 North American academic psychiatry centers from April 1994 to February 1998. The research team compared the effectiveness of paroxetine and imipramine with a placebo in teens with depression. They claimed paroxetine was safe and effective for adolescents in 2001.
In 2002, the FDA stated that the trial should have been considered a failed trial, yet that same year more than 2 million prescriptions for paroxetine were written for U.S. teens.
The new results, published in The BMJ (British Medical Journal), suggest that paroxetine and imipramine weren’t statistically or clinically different from a placebo and actually were tied to an increase in thoughts of suicide.
This new research highlights the importance of retracting the original study, which was not written by any of the original study’s authors, but rather a writer employed by the drug company – Glaxo