Researchers have found that an antidepressant prescribed to adolescents and marketed as safe is not only ineffective, but comes with many adverse side effects. Professor Jon Jureidini, of the University of Adelaide’s Critical and Ethical Mental Research Group (CEMH), reexamined the study that first put the drug on the market to test the drug’s true efficacy, and came up with some concerning results.

The previous research, known as Study 329, evaluated the effects of paroxetine, better known as Aropax, Paxil, or Seroxat, in a controlled, randomized trial where a group of adolescents diagnosed with major depression were either given the drug or a placebo. The study was published in 2001, hastily concluding that paroxetine had helped those who taken it when compared to those taking the placebo, and that no major adverse health effects were shown.

“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,” Jureidini said.

When looking at the data again, however, Jureidini found that paroxetine exacerbated the symptoms of some of those participating in the clinical trial. In fact, 11 of the patients taking paroxetine over the placebo, engaged in self-harming behaviors and attempted suicide, while only one person taking the placebo reported having these behaviors in a follow-up. What’s more, paroxetine did not relieve any of the symptoms associated with severe depression any more than the placebo did.

“This is highly concerning because prescribing this drug may have put young patients at unnecessary risk from a treatment that was supposed to help them,” Jureidini said.

Jureidini also notes that it’s important data be transparent to both patients and doctors alike. By making research data and protocols more available to the public, it can be reviewed more in-depth for potential negative side effects not previously observed. Jureidini cites a 2013 international researcher consortium known as “restoring invisible and abandoned trials” (RIAT) that says any research that has not been disclosed to the public should be made available, and that all misleading, or incorrect information should be revised. “Study 329 was one of the trails identified as in need of restoration, and because the original funder was not interested in revisiting the trial, our research group took on the task,” he said.

They’re happy that they did. Not only were they able to uncover the dangers of taking paroxetine as an antidepressant, they learned more about how incorrect data could impact a population. "Regulatory research authorities should mandate that all data and protocols are accessible," he says. "Although concerns about patient confidentiality and 'commercial in confidence' issues are important, the reanalysis of Study 329 illustrates the necessity of making primary trial data available to increase the rigor of evidence-based research," he said.

Paroxetine is also prescribed for non-hormone related treatment for hot flashes in menopausal women, as well as other mental health disorders like OCD, anxiety disorder, and PTSD.

Source: Jureidini J, et al. BMJ. 2015.