Antidepressant Paxil May Increase Suicide Risk In Teens

An antidepressant that's been widely prescribed for teenagers since its approval by the Food and Drug Administration in the early 2000s may come with some dangerous side-effects in teenagers, according to a new analysis of clinical trials.

Researchers found that paroxetine, sold as Paxil, has no clinical or significantly different effects on depression from the placebo treatment, and may even increase the risk of some side effects seen in patients, including increased risk of attempted suicides and attempts at self-harm. The new analysis is based on study data published in the British Medical Journal.

In the original study, funded by GlaxoSmithKline (GSK), referred to as Study 329, scientists went to 12 psychiatric facilities between 1994 and 1998 with 275 adolescents who had been diagnosed with major depression for at least eight weeks. Participants were randomized in the trail to receive eight weeks of paroxetine, imipramine-another antidepressant that's sold as Tofranil-or a placebo.

These findings revealed that based on the Hamilton depression scale, paroxetine lowered participant depression scores the most, at 10.7, with the placebo second, at 9.1 and imipramine last, at 9.0. However, the study has received significant criticism as researchers believe the data is not statistically significant.

However, a reanalysis of the study found very different conclusions.

"We also learned a lot about incorrect reporting and the considerable fall out that can be associated with distorted data," said Jon Jureidini, a researcher at the University of Adelaide, in a press release. "Regulatory research authorities should mandate that all data and protocols are accessible. 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."

"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 pediatric and adolescent patients given antidepressants like paroxetine," the company said in its statement. "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."

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