Kim: Status of reports of adverse events related to botanical herbal medicines with toxic precautions officially managed by Korean government: A descriptive analysis from WHO VigiAccess
Original Article
The Journal of Korean Medicine 2024; 45(1): 163-179.
Status of reports of adverse events related to botanical herbal medicines with toxic precautions officially managed by Korean government: A descriptive analysis from WHO VigiAccess
Department of Internal Medicine, Dongguk University Ilsan Oriental Medicine Hospital
Correspondence to:Mikyung Kim, Dongguk University Ilsan Oriental Medicine Hospital, 27, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, 10326, Tel: +82-31-961-9045, E-mail: 01mkkim@gmail.com
Received January 23, 2024 Revised February 12, 2024 Accepted February 16, 2024
Abstract
Objectives
This study was aimed to review the global status of adverse event (AE) reports and the characteristics of the reported AEs of plants managed as herbal medicines (HMs) with toxic precautions in Korea.
Methods
This is a cross-sectional quantitative study that analyzed information available through VigiAccess, a website that provides summarized statistical information from the WHO’s global AE database to the public. VigiAccess was searched in 8 Jan, 2024. Information on the total number of reports, number of reports by year and continent, and the age and gender of patients were obtained, and the types of frequently reported AEs were also reviewed.
Results
Data on the status of report submissions were obtained for a total of 9 HMs including Aconitum ciliare, Aconitum carmichaeli, Arisaema japonicum, Pinellia ternata, Euphorbiae Lathyridis, Croton tiglium, Strychni Ignatii, Strychnons nux-vomica, and Linum usitatissimum. The number of reports per HM was from 1 to 137. The most commonly reported type of AEs were gastrointestinal disorders in most of the HMs, followed by neurological disorders. Serious adverse events were reported only in Strychni Ignatii, Strychnons nux-vomica, and Linum usitatissimum, including one case of death.
Conclusions
This study shows the status of reported AEs of botanicals considered as HMs with toxic precautions in Korea based on real world data. However, when interpreting the findings of this study, readers should consider the significant limitations of this study mainly because of the characteristics of the data source.
X-axis: age range, Y-axis: number of reports for each herbal medicine
A. ciliare (n=2): Aconitum ciliare, A. carmichaeli (n=13): Aconitum carmichaeli, AJ (n=3): Arisaema japonicum, PT (n=17): Pinellia ternata, EL (n=1): Euphorbiae Lathyridis, CT (n=1): Croton tiglium, SI (n==26): Strychni Ignatii, SN (n=39): Strychnons nux-vomica, and LU (n=137): Linum usitatissimum
d: day, m: month, y: year
Fig. 3
Number of Reports by System of Organ Class (SOC)
A. ciliare (n=2): Aconitum ciliare, A. carmichaeli (n=13): Aconitum carmichaeli, AJ (n=3): Arisaema japonicum, PT (n=17): Pinellia ternata, EL (n=1): Euphorbiae Lathyridis, CT (n=1): Croton tiglium, SI (n==26): Strychni Ignatii, SN (n=39): Strychnons nux-vomica, and LU (n=137): Linum usitatissimum
BL: Blood and lymphatic system disorders; CA: Cardiac disorders; EA: Ear and labrinth disorders; EN: Endocrine disorders; EY: Eye disorders; GA: Gastrointestinal disorders; GE: General disorders and administration site conditions; HE: Hepatobiliary disorders; IM: Immune system disorders; INF: Infections and infestations; INJ: Injury, poisoning and procedural complications; INV: Investigations; ME: Metabolism and nutrition disorders; MU: Musculoskeletal and connective tissue disorders; NEO: Neoplasms benign, malignant and unspecified; NER: Nervous system disorders; PRE: Pregnancy, puerperium and perinatal conditions; PRO: Product issues; PS: Psychiatric disorders; REN: Renal and urinary disorders; REP: Reproductive system and breast disorders; RES: Respiratory, thoracic and mediastinal disorders; SK: Skin and subcutaneous tissue disorders; SO: Social circumstances; SU: Surgical and medical procedures; VA: Vascular disorders
hypercoagulation leukopenia thrombocytopenia atrioventricular block complete bradycardia cardiac failure cardiovascular disorder extrasystoles left ventricular dysfunction tachycardia thyroditis diplopia eye irritation lacrimation increased ocular hyperaemia papilloedema photophobia photopsia abdominal dyscomfort dry mouth duodenal ulcer dysphagia flatulence haematochezia irritable bowel syndrome lip oedema malabsorption peptic ulcer haemorrhage rectal haemorrhage salivary hypersecretion tongue oedema application site erythema application site pain chest discomfort chest pain drug interlerance feeling abnormal feeling hot feeling jittery gait disturbance herbal interaction infusion site erythema infusion site pain infusion site reaction infusion site swelling oedema pain therapeutic product effect decreased Budd-Chiari syndrome hepatic filure hepatic function abnormal hepatic pain hepatitis cholestatic hepatitis fulminant hepatitis ftoxic hepatocellular injury jaundice cholestatic portal vein thrombosis abscess candida infection diverticulitis eye infection viral herpes simplex herpes zoster nasopharyngitis urinary tract infection accidental exposure to product inappropriate schedule of product administration limb injury medication error scar vascular injury ALT increased AST increased bleeding time prolonged blood aldosterone decreased blood iron decreased blod potassium increased blood TSH abnormal blood TSH decreased blood urine present carbohydrate antigen 125 increased chest X-ray abnormal coagulation time prolonged cortisol decreased drug level below therapeutic full blood count heart rate increased HDL decreased INR decreased INR fluctuation lipids increased liver function test increased LDL increased RBC count thyroid function test abnormal WBC count decreased diabetes mellitus hypercholesterolaemia hyperglycaemia hypokalaemia lactose intolerance overweight weight loss poor arthralgia back pain breast cancer prostate cancer burning sensation cerebral venous sinus thrombosis cerebral venous thrombosis coordination abnormal diabetic neuropathy disturbance in attention dysgeusia generalised tonic-clonic seizure haemorrhagic stroke hypoaesthesia loss of consciousness memory impairment movement disorder neuropathy peripheral sedation seizure premature labour device breakage device kink device occlusion product formulation issue agitation behaviour disorder confusional state fear hallucination insomnia irritability poor quality sleep acute kidney injury crystal nephropathy renal impairment renal pain urinary incontinence breast pain heavy menstrual bleeding vaginal haemorrhage oropharyngeal pain respiratory distress rhinorrhoea tachypnoea throat irritation blister dermatitis contact dry skin nail ridging pain of skin prosriasis purpura rash papular skin fissures skin irritation urrticaria social problem stent placement blood pressure fluctuation flushing hot flush hypotension
Bold font and underline: serious adverse event, italic and underline: liver injury
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