Premium
A comparison of patterns of spontaneous adverse drug reaction reporting with St. John's Wort and fluoxetine during the period 2000–2013
Author(s) -
Hoban Claire L,
Byard Roger W,
Musgrave Ian F
Publication year - 2015
Publication title -
clinical and experimental pharmacology and physiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.752
H-Index - 103
eISSN - 1440-1681
pISSN - 0305-1870
DOI - 10.1111/1440-1681.12424
Subject(s) - fluoxetine , medicine , adverse effect , hypericum perforatum , antidepressant , medical prescription , serotonin reuptake inhibitor , drug , depression (economics) , clinical trial , reuptake inhibitor , pharmacology , drug reaction , psychiatry , serotonin , anxiety , receptor , macroeconomics , economics
Summary Herbal medicines are perceived to be safe by the general public and medical practitioners, despite abundant evidence from clinical trials and case reports that show herbal preparations can have significant adverse effects. The overall impact of adverse events to herbal medicines in Australia is currently unknown. Post marketing surveillance of medications through spontaneous adverse drug reaction ( ADR ) reports to the Therapeutic Goods Administration ( TGA ) is one way to estimate this risk. The patterns of spontaneously reported ADR s provide insight to herbal dangers, especially when compared with patterns of a mechanistically similar conventional drug. The study compared the pattern of spontaneously reported ADR s to St. John's Wort ( Hypericum perforatum ), a common herbal treatment for depression which contains selective serotonin reuptake inhibitors ( SSRI ), to fluoxetine, a commonly prescribed synthetic SSRI antidepressant. Spontaneous ADR reports sent to the TGA between 2000–2013 for St. John's Wort ( n = 84) and fluoxetine ( n = 447) were obtained and analysed. The demographic information, types of interaction, severity of the ADR , and the body systems affected (using the Anatomical Therapeutic Chemical classification system) were recorded for individual ADR cases. The majority of spontaneously reported ADR s for St. John's Wort and fluoxetine were concerning females aged 26–50 years (28.6%, 22.8%). The organ systems affected by ADR s to St John's Wort and fluoxetine have a similar profile, with the majority of cases affecting the central nervous system (45.2%, 61.7%). This result demonstrates that herbal preparations can result in ADR s similar to those of prescription medications.