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International Journal of Phytomedicine and Phytotherapy

Table 2 Reviews recommendations on pharmacovigilance of nephrotoxic herbal medicines

From: Overview on pharmacovigilance of nephrotoxic herbal medicines used worldwide

Recommendations Reference
medicinal plants are associated with the pathogenesis of renal diseases in order to update healthcare practitioners to keep abreast with the current information on the medicinal herbal therapies and consequences that may be associated with such health-seeking behaviors [41]
Some evidence was in line with the potential nephrotoxicity of plants and their reformers. Despite the lack of clinical research for evaluation of their renal damage, the herbs may be focused in term of their nephrotoxicity; and there is a need for further studies on the scientific basis of their nephrotoxicity [42]
Strict controls on the presence of adulterants within herbal medicines, labeling of dosages and contraindications, and manufacturing techniques must be maintained to ensure the safety of those consuming herbal medicines. [43]
Clinicians should consider herbal medicine use in patients with unexplained acute kidney injury or progressive chronique kidney disease. In addition, exposure to herbal medicine containing aristolochic acid may increase risk for future uroepithelial cancers, and patients require appropriate postexposure screening [44]
it is important that alternative medicines not be demonized as a whole, but that their use and consequences be closely observed and reported to build a more comprehensive understanding of their impact in our clinical practice and to foster research on the potential harm or, in some cases, possible benefits [45]
Considering the complexity of the toxic components and the diversity of their acting pathway, a lot of work needs to do on pharmacovigilance, “Omics” technologies, and administration of mixtures alleviating toxicities. Pharmacovigilance methods can be used for monitoring kidney toxicity traditional Chinese medicines safety. “Omics” technologies have the potential for the development of molecular markers hopefully allowing for detection of early changes in toxic kidney injury with high sensitivity and specificity. These researches may help us to deeply learn the mechanism of traditional Chinese medicines renal toxicity at the molecular and gene level [46]
Use of modern cell biological, biochemical, in vitro and in vivo techniques for the evaluation of medicinal plants safety is needed [47]
Herbal medicines related to either severe or moderate adverse events supported by a case report should be avoided. [48]
Cooperation between orthodox physicians and traditional practitioners is needed to bring together the full case details. Independent scientific assistance on toxicological investigation, botanical verification can be invaluable for full evaluation of any case report. Systematic pharmacovigilance is essential to build up reliable information on the safety of herbal medicines for the development of appropriate guidelines for safe effective use [7]
It is deemed necessary that a basic knowledge of the pharmacological aspects of phytotherapy be included in the regular Course of Medicine. [49]
Phytovigilance: A medical requirement and a legal obligation [8]
Need to incorporate pharmacovigilance of herbal medicine to the curriculum [50]
There is a need for herbal medicine regulation, technical and training assistance, and funding as being major challenges to HM pharmacovigilance in countries. Particular attention to the development of pharma- covigilance of herbal medicine is required in Africa. [6]
The use of indigenous drugs, herbal medicine and traditional materiamedica can only be understood through a combination of historical, ecological, economic, cognitive, and pharmacolog- ical approaches, while anecdotal references are lost in space and time. [51]
A demonstration of the safety of herbal medicines for registration purposes should include at least in vitro and in vivo genotoxicity assays, long-term rodent carcinogenicity tests (for drugs intended to be continuously used for > 3 months or intermittently for > 6 months), reproductive and developmental toxicity studies (for drugs used by women of childbearing age), and investigation of the effects on drug-metabolizing enzymes. [52]
Government organizations should assume responsibility to provide active guidance and effective regulation [53]