Even more suicide attempts in clinical trials with paroxetine randomised against placebo

BMC Psychiatry. 2006 Nov 28;6:55. doi: 10.1186/1471-244X-6-55.

Abstract

Background: Following our previous publication we have received critical comments to our conclusions as well as new data that are strengthening our findings.

Results: With the new data, 11 suicide attempts among patients on paroxetine against 1 among patients on placebo, we found with a Bayesian technique that the posterior probability that medication with paroxetine is associated with an increased intensity per year of a suicide attempt is from 0.98 to 0.99, depending on the prior. We found that the comment to our article by GSK representatives contained errors, misunderstanding and unwillingness to accept Bayesian principles in the analysis of clinical trials.

Conclusion: We were in our previous publication, with preliminary data and a Bayesian approach, able to raise a concern that suicide attempts might be connected with the use of paroxetine. This suspicion has now been confirmed.

MeSH terms

  • Adult
  • Antidepressive Agents, Second-Generation / adverse effects*
  • Antidepressive Agents, Second-Generation / therapeutic use
  • Bayes Theorem
  • Drug Industry
  • Humans
  • Paroxetine / adverse effects*
  • Paroxetine / therapeutic use
  • Placebos
  • Randomized Controlled Trials as Topic / statistics & numerical data
  • Risk Assessment
  • Suicide, Attempted / statistics & numerical data*

Substances

  • Antidepressive Agents, Second-Generation
  • Placebos
  • Paroxetine