A comparison of patterns of spontaneous adverse drug reaction reporting with St. John's Wort and fluoxetine during the period 2000–2013

Abstract

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 ADRs provide insight to herbal dangers, especially when compared with patterns of a mechanistically similar conventional drug. The study compared the pattern of spontaneously reported ADRs 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 ADRs for St. John's Wort and fluoxetine were concerning females aged 26-50 years (28.6%, 22.8%). The organ systems affected by ADRs 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 ADRs similar to those of prescription medications.

Hypersensitive adverse drug reactions to glucosamine and chondroitin preparations in Australia between 2000 and 2011

“…Moreover, in the absence of allergy workup these reports may be misleading. On the other hand, the patterns of ADRs seen here is markedly different to other herbal medicines reported through the TGA system 14 15. In particular, Echinacea, a known allergen, had fewer reports associated with hypersensitivity (53%) and all were mild 15…”

“…These patients are also more likely to be using other medication(s) for the same or another medical condition. This is an important consideration when contemplating glucosamine and chondroitin administration, given that published data shows that ADRs to complementary medicines are most severe when taken concomitantly with conventional medicines 14 15. Regardless, this drug combination is often recommended as an adjunct to traditional prescription pharmaceuticals and non-pharmacological treatments 5.…”

“…Methods followed Hoban et al ,14 15 with the substitution of the Hartwig scale of severity for of the Brown hypersensitivity grading system 16. Briefly, ADRs to glucosamine were spontaneously reported by patients to their General Practitioners between 2000 and 2011.…”

A systematic review of St. John’s wort for major depressive disorder

“…Furthermore, a review of popular herbal preparations found SJW interacted with more medications than any of the other herbs and dietary supplements [54]. Post-marketing surveillance of spontaneous adverse drug reactions indicated that SJW produced a similar adverse event profile to fluoxetine, with mild and severe adverse events more common with SJW while life-threatening events were more common with fluoxetine but still occurred [55]. While reports of rare adverse events cannot be dismissed based on RCT data, it is noteworthy that SJW appears to have fewer adverse events than antidepressant medication in the reported comparative analyses.…”

“…This aspect is in particular relevant to patients with severe depression. Post-marketing surveillance in Australia found that, though SJW was not often given with an SSRI, there was a high proportion of adverse effects when this occurred, including a report of life-threatening serotonin syndrome [55]. While concerns about potential drug interactions will have prompted researchers to not provide patients with SJW in addition to standard antidepressant medication, we also did not identify studies that evaluated the effect of SJW treatment adjunctive to psychotherapy.…”