Rational Use of Herbal Products in Pediatric Patients Treated With Anticancer Drugs in the European Union.
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INTRODUCTION: The use of herbal medical preparation (HMP) is rising among pediatric oncology patients, often to manage treatment-related symptoms. Their effectiveness remains uncertain, and the risk of herb-drug interactions is underestimated. Objectives were to evaluate the benefit-risk balance of commonly used herbal medicines in pediatric oncology and provide evidence-based recommendations. METHODS: A retrospective review of herbal medicine-related inquiries submitted to the Angers Regional Pharmacovigilance Centre (2016-2019) was conducted. Fourteen medicinal plants were selected on the basis of their use for abdominal pain, appetite loss, nausea/vomiting, sleep, and anxiety. Their suitability for pediatric use, efficacy, toxicity, pharmacological mechanisms, and potential interactions with anticancer and supportive therapies were evaluated. Data were sourced from European Medicines Agency (EMA) monographs, PubMed, Memorial Sloan-Kettering Cancer Center (MSKCC), and pharmacological reference texts. Benefit-risk ratios and recommendation levels were assigned, and recommendations of proper use were summarized for herbal medicines without any objections. RESULTS: Six medicinal plants were deemed to have a favorable benefit-risk profile: leaf of peppermint, lemon balm and sweet fennel for abdominal pain; ginger for nausea and vomiting; lime tree and valerian for anxiety and sleep disorders. However, evidence remains limited, and product quality may vary. Sweet fennel and valerian should be used with caution in the presence of cytochrome P450 3A4 substrate. CONCLUSION: Some medicinal plants may be cautiously considered in pediatric oncology, but the risks of pharmacokinetic and pharmacodynamic interactions are substantial. This study proposes a shortlist of plants that may be considered and HMPs with potentially good benefit-risk ratios. These findings should not be interpreted as therapeutic recommendations.