Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase.

Introduction: Use of herbal medicines (HMs) is widespread across the world, with many people relying on HMs for their primary healthcare or using HMs in the context of a healthy life style. HMs originate from plant material and, as such, are often seen as "natural" and believed to be (relatively) safe by patients. Hepatobiliary disorders have been associated with numerous HMs. Aim: This paper aims to analyze reporting patterns for hepatobiliary disorders associated with HMs use from reports submitted to the WHO global database of individual case safety reports (ICSRs) VigiBase. Methods: A data extraction in VigiBase, the WHO international database of ICSR reports, was performed by the Uppsala Monitoring Centre on 2019-01-16. The dataset contained all ICSRs where an HM was identified with the UMC-assigned ATC code "V90: unspecified herbal and traditional medicine" and where the HM was classified as being either the suspected drug or an interacting drug, and containing at least one adverse reaction in the MedDRA® System Organ Class (SOC) Hepatobiliary Disorders (HBD). Descriptive analyses in Excel 2013® were used to determine general characteristics of the reports in the broad data set, including total number of reports, reporting country and patient characteristics. For single suspect herbal reports, reports categorized as "serious" according to CIOMS criteria (CIOMS), 2001) were extracted. Results: In total, 2,483 reports describing with at least one ADR in the SOC HBD were extracted from VigiBase. In total, 780 (31.4%) reports concern only one suspect HM. However, for 188 reports of these reports (24.1%), the single suspect herbal preparation contains more than one herbal ingredient. The 592 reports for single suspect herbal preparations described a total of 764 ADRs in the SOC HBD. Jaundice was the most reported ADR for these reports. Conclusion: Almost 2,500 reports for HMs and with at least one ADR coded to the MedDRA® SOC HBD were retrieved from VigiBase. Of the HBD SOC HM reports, around 25% concerned a single herbal species as the suspect "drug." Substantial issues with coding of the suspect herbal drugs were found. In-depth causality assessment of the cases is needed to draw conclusions on the strength of the relationships.

An ethnobotanical survey of medicinal plants used for diabetes treatment in Rabat, Morocco.

Diabetes mellitus is a major public health problem in Morocco. The value of ethnobotanical information is now increasingly acknowledged. To inventory and to provide ethnobotanical information on some of the medicinal plants used in traditional medicine to treat diabetes in Rabat (Morocco), a survey was undertaken from March 1st to April 30th 2018. This survey was conducted using a semi-structured questionnaire targeting diabetic patients from the SOS Diabetes Center. 334 diabetic patients were interviewed. Of this group, 53.6% (34 men and 145 women) use medicinal plants to control their diabetes. 47.2% have type 2 diabetes and 52.5% have type 1diabetes. Thirty plant species belonging to 18 botanical families were recorded for the treatment of diabetes. The most represented families were Lamiaceae with 8 species followed by Fabaceae with 3 species. Based on the highest number of users, the most important species were Trigonella foenum-graecum L. (15.4%), Salvia officinalis L. (13.3%) and Olea europaea L. (10.8%). Leaves (47.5%), seeds (20.2%) and stem (17.6%) were the parts predominantly used to prepare the formulations, which were mainly infusions (50.9%), administrated by the oral route (98.9%). Some plants were used only by type 1 diabetics while others were used by type 2 diabetics. The observed adverse events related to the use of medicinal plants were represented by occasional heartburn in 2.2% of diabetic patients. This study is the first to collect and document information on medicinal plants and how they are used by diabetic patients. Calamintha alpina L. is reported for the first time at the international level as used in traditional treatment of diabetes and seven others were reported as new medicinal plants used to treat diabetes in Morocco. This will extend the list of plants already mentioned as used for diabetes. Further research should be carried out to validate the antidiabetic uses of most of these plant species.

Pharmacovigilance of herbal medicines in Africa: Questionnaire study.

In order to describe and evaluate Herbal Medicine (HM) pharmacovigilance in African countries who are members of the WHO International Programme for Drug Monitoring a survey questionnaire was sent to the national centres and national drug regulatory agencies of these countries. Data collection was carried out from October 1st to 31st December, 2014. Among the total of 39 African countries, 34 (87.2%) answered the questionnaire and 25 (64.1%) accepted to share their data in this publication. Spontaneous adverse reaction reporting for HM is voluntary in 7 (43.7%) countries. HM pharmacovigilance programmes covered suspected adverse HM reactions in 14 (87.5%) countries; HM information in 7 (43.7%) countries; HM dependence or abuse in 6 (37.5%) countries; medication errors in 5 (31.2%) countries; falsification and adulteration in 2 (each 12.5%) countries and HM-drug interactions in 1 (6.3%) country. Groups in countries encouraged to submit herbal reports were pharmacists and physicians (both n=15); nurses (n=13); herbal therapists (n=12); patients (n=11) and local manufacturers (n=8). The number of herbal reports received by most countries was very low or even insignificant. VigiFlow is used by 10 countries. Information from pharmacovigilance activities is disseminated using many means. Only five countries have regulatory status and quality control of their HM products. The participants identified a need for HM regulation, technical and training assistance, and funding as being major challenges to HM pharmacovigilance in countries. Particular attention to the development of pharmacovigilance of HM is required in Africa.

Side effects of cade oil in Morocco: an analysis of reports in the Moroccan herbal products database from 2004 to 2012.

Cade oil is a dark, faintly aromatic oil which is distilled from the branches and wood of Juniperus oxycedrus. Although this oil is known to have toxic effects related to its content of phenols, cade oil continues to be used in folk medicine. Because of this use, a determination of the safety and possible side effects of cade oil is required. The safety of cade oil is discussed based on the experience of the Moroccan pharmacovigilance herbal products database, and supported by literature. The data on the adverse effects of cade oil suggests that it could have life-threatening effects which can occur following topical exposure, ingestion or inhalation. Phenol's adverse effects involve a wide variety of organ systems such as the gastro-intestinal system, central and peripheral nervous systems, cardiovascular, liver and biliary systems, the urinary tract, skin and appendages, respiratory system. Platelet function, bleeding and clotting, vision, metabolism, and white cell and reticuloendothelial system function are also affected.

Safety monitoring of herb-drug interactions: a component of pharmacovigilance.

Adverse drug reactions, including those resulting from interactions between herbal medicines and conventional drugs, are a public health problem worldwide. The need for pharmacovigilance for herb-drug interactions (HDIs) is essential for the identification and assessment of risks of using herbal products (questionable safety, efficacy and quality), which are not always tested with rigor, or often not subject to approval by regulatory agencies. Spontaneous and active surveillance conducted by national pharmacovigilance centres permits a rapid detection of potentially harmful combinations of products. The incidence and prevalence of HDIs are difficult to predict because of the underreporting of adverse effects. It is important for health professionals, consumers, regulatory authorities and suppliers of herbal medicines to be aware of the possible adverse effects and drug interactions caused when herbal medicines are co-administered with conventional drugs. National pharmacovigilance centres continue to play a significant role in increasing awareness of drug safety, in this case with HDIs. The authors' objective for this paper is to provide awareness among policy makers responsible for the design of appropriate pharmacovigilance practices and therefore to highlight the importance of pharmacovigilance in the safety monitoring of HDIs.

Epileptic seizure induced by fennel essential oil.

An epileptic seizure is reported in a 38-year-old woman, known to be an epileptic patient. Although she was under antiepileptic treatment and had well-controlled epilepsy, she developed a typical generalised tonic-clonic seizure and remained unconscious for 45 minutes following ingestion of a number of cakes containing an unknown quantity of fennel essential oil. Involuntary diarrhoea accompanied her epileptic seizure. This reported case recalls the fact that fennel essential oil can induce seizures and that this oil should probably be avoided by patients with epilepsy. Labelling of products with fennel essential oil should refer to the risk of seizures, particularly for patients with epilepsy. An awareness programme should involve all stakeholders affected by this issue.

Drug interactions with herbal medicines.

The use of herbal medicines (HM) is on the rise among the global population. Although the safety profile of many herbal medicines is promising, accumulated data show evidence of significant interactions with medications, which can place individual patients at great risk. A range of electronic databases have been reviewed for articles published in this field: Medline, Allied and Complementary Medicine Database, HealthSTAR, AMBASE, CINHAL, Cochrane Library, as well as Internet documents and manually searched references in medical journals. In this review, we examined the literature from 1966 to 2006 and focused on the importance of the risk of drug interactions and potential side effects when HM are involved. We discuss these in light of the documented findings. A review of the problematic issues is given and recommendations are made in order to encourage the setting up of clinical trials on HM and herb-drug interactions.

[Botanicus and phytotox: data base of plant toxicology. Interest in emergency toxicology and in phytovigilance]. / Botanicus et phytotox: base de données de toxicologie végétale. intérêt en toxicologie d'urgence et en phytovigilance.

The purposes of this project were to summarize more than 279 standard botanical names and their 2294 vernacular ones (French common names, Arabic common names and Moroccan common names) for the first part of database named "Botanicus". The second part of this data base named "Phytotox", concerns relevant toxic data of 120 plants available in Mediterranean region. The database will be useful for emergency physicians, particularly of Maghreb and French- speaking countries. Botanicus and Phytotox permit to assist them in providing fast and appropriate answers to questions concerning adverse effects associated with plant use.

[Acute intoxication by redoul (Coriaria myrtifolia L.). Three observations]. / Intoxication aiguë par le redoul (Coriaria myrtifolia L.). Trois observations.

INTRODUCTION: Coriaria myrtifolla L. (Redoul) is a shrub of the Mediterranean area. Poisoning with this plant is often accidental, following ingestion of the plant's fruit that are often mistaken for blackberries. OBSERVATIONS: Having eaten Coriaria myrtifolla L. berries, three sisters suffered from acute poisoning. One died. COMMENTS: Toxic effects are characterized by digestive (nausea, vomiting, abdominal pain), neurological (obnubilation, convulsions and their complications), and respiratory disorders (polypnea, respiratory problems, apnea, short and superficial respiration) together with myositis of the pupils. Treatment of this poisoning is purely symptomatic. In the case of convulsions, rapid resuscitation in an intensive care unit in necessary.