Analysis of spontaneous adverse drug reactions to echinacea, valerian, black cohosh and ginkgo in Australia from 2000 to 2015

Hoban, Claire; Byard, Roger W.; Musgrave, Ian F.

doi:10.1016/j.joim.2019.04.007

Cited by 9 publications

(11 citation statements)

References 20 publications

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“…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…”

Section: Discussioncontrasting

confidence: 89%

“…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.…”

Section: Discussionmentioning

confidence: 99%

“…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.…”

Section: Methodsmentioning

confidence: 99%

“…Fields extracted from the case line listings were case number, year of report, sex, age, medicines, reaction and outcome. Classification and analyses included administration as a monotherapy (exclusive) or co-therapy (combined), demographic information (age and sex), severity (mild, moderate or severe, based on the Brown scale for generalised hypersensitivity reactions (table 1)) 15. The Brown scale also considers the body system effected along with the type of reaction.…”

Section: Methodsmentioning

confidence: 99%

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

Hoban

Byard

Musgrave

2019

Postgraduate Medical Journal

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Purpose of the studyThis study investigates spontaneous adverse drug reactions (ADRs) to glucosamine and chondroitin in the Australian population between 2000 and 2011, with a primary focus on hypersensitivity reactions.Study designCase reports of ADR to glucosamine and chondroitin sent to the Therapeutic Goods Administration between 2000 and 2011 were obtained and analysed. The demographic information and severity of the ADR were recorded for individual ADR cases. These reactions were classified according to the Brown et al grading system for generalised hypersensitivity reactions. This included mild hypersensitivity reactions (generalised erythema, urticaria and angioedema) through to moderate hypersensitivity reactions (wheeze, nausea, vomiting, dizziness (presyncope), diaphoresis, chest or throat tightness and abdominal pain), and more severe reactions (hypotension, confusion and collapse).ResultsIn this study of 366 ADRs to glucosamine and chondroitin preparations, 71.85% of cases (n=263) were found to have hypersensitivity reactions. Of these 263 cases, 92 cases were classified as mild (eg, pruritus, urticaria and lip oedema), 128 cases classified as moderate (such as dyspnoea, nausea and abdominal pain), and 43 cases classified as severe (including amnesia, gait disturbance, somnolence and hypotension). It is not clear whether the patients involved had a known shellfish allergy or underlying atopy.ConclusionResults of this investigation support the need for clear labelling on glucosamine and chondroitin preparations to raise awareness of possible adverse events for those predisposed to allergy or atopy in response to shellfish.

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Section: Discussioncontrasting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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

Hoban

Byard

Musgrave

2019

Postgraduate Medical Journal

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“…In contrast, there is enough evidence suggesting the common occurrence of adverse drug reactions (ADR) leading to patient morbidity, mortality, and implicating a financial burden on healthcare systems around the world. [1][2][3] The WHO defines an ADR as "any drug effect, which is a noxious, unintended and undesired effect and occurs at normal therapeutic doses." 4 The need to establish a mechanism to evaluate ADRs was felt to ensure medicine safety and monitoring because of the thalidomide disaster in the early 1960s that resulted in many babies born with malformed limbs.…”

Section: Introductionmentioning

confidence: 99%

An Exploration of Knowledge, Attitude, and Practices of Physicians toward Pharmacovigilance at Tertiary Care Hospitals in Khyber-Pakhtunkhwa Province, Pakistan

Sharif

Murtaza

Kharaba

et al. 2021

The American Journal of Tropical Medicine and Hygiene

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Drug safety assures the effectiveness, safety, and security of drugs, vaccines, and other biologicals to protect public health. Medication-related errors coupled with unjudicial medication practices often cause a catastrophic impact on the healthcare system globally. The present study aimed to assess the knowledge, attitude, and practice of physicians toward pharmacovigilance and barriers to adverse drug reaction (ADR) reporting at tertiary care hospitals in Khyber-Pakhtunkhwa (KP) province, Pakistan. A descriptive cross-sectional study was conducted among registered doctors working in seven tertiary care hospitals from seven administrative divisions of KP province of Pakistan from July 2019 to March 2020. During the study period, 358 physicians who fulfilled the inclusion criteria and agreed to participate completed and returned the validated structured questionnaires. Descriptive and inferential statistics were applied for data analysis. The majority of physicians had poor knowledge (81.3%) regarding pharmacovigilance along with poor reporting practices (94.9%), although (96.5%) had a positive attitude toward ADR reporting. A significant barrier identified was the unavailability of reporting forms (95.9%), whereas mandatory ADR reporting (96.2%) was the major factor to encourage ADR reporting. Physicians aged ≥ 41 and experience ≥ 11 years had significantly more knowledge than other categories (P < 0.001). Significant association (P < 0.001) of physicians’ knowledge and practice were found where 77.2% of the participants having poor knowledge reported poor practices. Physicians’ understanding of pharmacovigilance was suboptimal, although they have a positive attitude toward ADR reporting. Thus, there is a need for continuous education and training programs to support pharmacovigilance activities that could improve physicians’ understanding.

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Thai stakeholders’ awareness and perceptions of the patient adverse event reporting system for herbal medicines: a qualitative study

Worakunphanich

Suwankesawong²,

Youngkong

et al. 2023

Int J Clin Pharm

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Background In Thailand, the consumption of herbal medicines has been increasing. Adverse events (AEs) of herbal medicines have been identified through the spontaneous reporting system. However, the number of patients reporting AEs of herbal medicines remains limited. Aim To explore the awareness and perceptions about the patient reporting system and to explore attitudes towards safety of herbal medicines, experiences, and intention to report AEs of herbal medicines. Method Semi-structured in-depth interviews were conducted with stakeholders (patients, community pharmacists, village health volunteers, and consumers who had experienced submitting a complaint about health products to the Consumers Foundation). Additionally, a focus group discussion was held with stakeholders (academics, herbal medicine manufacturers, healthcare professionals, policy maker who was responsible for promoting the use of herbal medicines, pharmacovigilance staff, patient, and representative from patient organisations). The data were audio recorded, transcribed verbatim and analysed using thematic analysis. Results Fifty participants were interviewed and the focus group discussion included 12 participants. Patients had positive attitudes towards the safety of herbal medicines. Lack of awareness of the patient reporting system was identified. Nevertheless, all stakeholders acknowledged the importance of the safety monitoring of herbal medicines and indicated a willingness to report AEs via the patient reporting system in the future. A simple reporting system, a variety of reporting channels, the provision of feedback, and providing rewards would motivate patients to report AEs. Conclusion Although there is a lack of awareness, this provides a great opportunity to improve patient AE reporting system for herbal medicines in Thailand.

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Analysis of spontaneous adverse drug reactions to echinacea, valerian, black cohosh and ginkgo in Australia from 2000 to 2015

Cited by 9 publications

References 20 publications

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

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

An Exploration of Knowledge, Attitude, and Practices of Physicians toward Pharmacovigilance at Tertiary Care Hospitals in Khyber-Pakhtunkhwa Province, Pakistan

Thai stakeholders’ awareness and perceptions of the patient adverse event reporting system for herbal medicines: a qualitative study

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