A new study, published on September 17, 2015, has found that the antidepressant, paroxetine, commonly known as Paxil, is not safe for use among teens. This study directly discredits the 2001 study which claims that “paroxetine is safe and effective for the treatment of depressed adolescents.” The original study, funded by the drug’s marketer, was called into question by RIAT (restoring invisible and abandoned trials), an organization that calls for the “public release of data behind unpublished or questionable clinical trials.”
Dr. John Nardo, co-author of the new study, states, “our [study] says paroxetine is neither safe nor effective in the treatment of adolescents.” The study finds that the drug increases teen’s risk of self-harm or suicide.
In the original study, involving children aged 12-18, the children were split into three groups and each group was given three different drugs (Paxil, placebo, and Tofranil). “The new reanalysis revealed that neither Paxil nor high-dose imipramine [Tofranil] was more effective than a placebo in the treatment of major depression in adolescents. The researchers also considered the increase in harms with both drugs to be clinically significant.” The new study notes that the results seem to have been altered by the researcher’s decisions. Additionally, unfavorable data was omitted based on the idea that “differences between Paxil and placebo were not statistically significant.”
Dr. David Henry, co-author of the study, writes, “It's not clear whether it was deliberate or accidental, but it wrongly gave the impression that an antidepressant drug was effective and safe in children and adolescents. Where trials are going to determine treatment for very large numbers of people, we need to know they are effective and safe, and sometimes the results are wrong."
In 2003, the FDA gave Paxil a “black box” warning label. As such, the authors of the study do not believe patient health and safety since the initial study requires reanalysis.