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Related Experiment Videos

Safety database on fluvoxamine: analysis and report

W Wagner1, B Plekkenpol, T E Gray

  • 1Solvay Pharmaceuticals, Inc., Marietta, Georgia.

Pharmacopsychiatry
|May 1, 1993
PubMed
Summary
This summary is machine-generated.

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This review of fluvoxamine safety in depression shows that over half of patients experienced no adverse effects. Nausea was the most common side effect, leading to discontinuation in 15.1% of cases.

Area of Science:

  • Pharmacology
  • Clinical Trials
  • Psychiatry

Background:

  • Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) used to treat depression.
  • Understanding its safety and tolerability profile is crucial for clinical practice.

Purpose of the Study:

  • To review the safety and tolerability of fluvoxamine across numerous global marketing studies.
  • To analyze adverse experiences and treatment discontinuation rates in a large patient cohort.

Main Methods:

  • A comprehensive review of 54 worldwide marketing studies involving 24,624 patients treated with fluvoxamine.
  • Analysis of adverse experiences using COSTART body systems and assessment of discontinuation rates.

Main Results:

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  • 57.4% of patients experienced no adverse events; nausea (15.7%) was the most frequent side effect.
  • Digestive and nervous system adverse events were most common; 15.1% discontinued treatment due to adverse experiences.
  • Serious adverse events occurred in 2.5% of patients.

    • Conclusions:

    • Fluvoxamine demonstrates a generally acceptable safety and tolerability profile in depression treatment.
    • Nausea is a key adverse event to monitor, influencing treatment discontinuation.
    • Further research may explore risk factors for adverse events in specific patient populations.