Did intense adverse media publicity impact on prescribing of paroxetine and the notification of suspected adverse drug reactions? Analysis of routine databases, 2001-2004

Br J Clin Pharmacol. 2006 Feb;61(2):224-8. doi: 10.1111/j.1365-2125.2005.02527.x.

Abstract

Aim: To document the impact on clinical practice in England of media attention around possible adverse effects of paroxetine.

Design: Analysis of national selective serotonin reuptake inhibitor (SSRI) prescribing trends and yellow-card adverse drug reaction reports, 2001-2004.

Results: From a steady state in 2001, paroxetine prescribing declined sharply from April 2002, coinciding with a USA regulatory action; the subsequent decline in paroxetine prescribing was 1.87% per month (95% confidence interval - 2.06, -1.68). Other SSRI prescribing increased by 1% per month until a major UK review of SSRIs in children in December 2003, after which prescribing plateaued. Media publicity was associated with short-term peaks in yellow-card reports related to paroxetine.

Conclusion: Falls in paroxetine and other SSRI prescribing in the UK coincided, respectively, with regulatory communications from the USA and the UK, but associations may have noncausal or other explanations. Reports of adverse reactions to paroxetine appeared to increase after adverse media publicity about the drug.

MeSH terms

  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Antidepressive Agents, Second-Generation / administration & dosage
  • Antidepressive Agents, Second-Generation / adverse effects*
  • Databases as Topic
  • Drug Prescriptions / statistics & numerical data
  • England
  • Family Practice / statistics & numerical data
  • Family Practice / trends
  • Humans
  • Mass Media*
  • Paroxetine / administration & dosage
  • Paroxetine / adverse effects*
  • Practice Patterns, Physicians' / statistics & numerical data
  • Practice Patterns, Physicians' / trends
  • Serotonin Uptake Inhibitors / administration & dosage
  • Serotonin Uptake Inhibitors / adverse effects*

Substances

  • Antidepressive Agents, Second-Generation
  • Serotonin Uptake Inhibitors
  • Paroxetine